Monday, December 29, 2014

Roche Receives FDA Emergency Use Authorization for the LightMix® Ebola Zaire rRT-PCR Test

Roche today announced that the U.S. Food and Drug Administration (FDA) has provided an Emergency Use Authorization (EUA) for the LightMix® Ebola Zaire rRT-PCR Test for use on patients with signs and symptoms of Ebola Zaire virus infection in conjunction with epidemiological risk factors, such as individuals traveling from West Africa. The test is used for the detection of Ebola Zaire Virus in whole blood samples using the large installed base of Roche's LightCycler® 480 or cobas z 480 instruments.

"The LightMix® Ebola Zaire test is an easy-to-use molecular diagnostic test providing a solution for healthcare professionals to quickly detect the virus and start patient treatment as early as possible," said Roland Diggelman COO, Roche Diagnostics Division. "As a leader in diagnostics, Roche is committed to providing testing solutions for the world's most challenging healthcare emergencies. The FDA's granting of this EUA supports our commitment to healthcare professionals working to combat this deadly disease."

The LightMix® Ebola Zaire rRT-PCR Test has also been CE marked by the test's manufacturer, TIB MOLBIOL GmbH, and is available for use on the LightCycler® 480 or cobas z 480 instruments in markets accepting the CE mark. In addition, TIB MOLBIOL GmbH has submitted an Expression of Interest (EOI) for Emergency Assessment by the World Health Organization Prequalification of the In vitro Diagnostics Programme.

About the LightMix® Ebola Zaire rRT-PCR Test

Manufactured by TIB MOLBIOL GmbH and exclusively distributed by Roche, the LightMix® Ebola Zaire rRT-PCR Test is a one-tube duplex assay for the simultaneous, qualitative detection of Ebola Zaire Virus (detected in the West Africa outbreak in 2014) and an endogenous human house-keeping gene used as an internal control. The end-to-end process from sample preparation of whole blood to results can be achieved for 96 results in just over 3 hours. The test can also be used for smaller numbers of samples with a manual extraction processes, as well as labs using Roche's MagNA Pure 96 instrument for high throughput automated nucleic acid extraction. The test was developed to be run on the LightCycler® 480 or the cobas z 480 qPCR instruments, allowing the response to be most effective through utilization of abroad installed instrument base.

About Emergency Use Authorization Status

  • This test has not been FDA cleared or approved;
  • This test has been authorized by FDA under an Emergency Use Authorization for use by CLIA High Complexity Laboratories and similarly qualified non-U.S. laboratories;
  • This test has been authorized only for the detection of RNA from Ebola Zaire virus (detected in the West Africa outbreak of 2014) and not for any other viruses or pathogens; and
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of Ebola Zaire virus under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Corgenix Announces New Grants to Advance Work on Ebola Test Kit

Corgenix Medical Corporation, a worldwide developer and marketer of diagnostic test kits, has been awarded two grants totaling $818,000 to advance the development of an Ebola rapid diagnostic test kit.

The grants were awarded to Corgenix by the Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation. Corgenix has selected three subcontractors to assist on the project: Tulane University, Autoimmune Technologies, LLC and Zalgen Labs, LLC.

“The scope and seriousness of Ebola virus outbreaks have resulted in an increased urgency to bring testing and products to market as soon as possible,” said Douglass Simpson, Corgenix president and CEO. “We thank the Gates and Allen foundations for their support and commitment to our efforts to accelerate the development of a rapid test.”

The Corgenix point-of-care test kit currently under development is designed to be used in any clinical or field lab to determine in a matter of minutes if a patient is infected with Ebola. Corgenix and the Viral Hemorrhagic Fever Consortium (VHFC), a collaboration of academic and industry members headed by Tulane University and partially funded with support from the NIH, have already developed the ReLASV® rapid test for the Lassa fever virus. The Lassa product is CE marked as a diagnostic test, enabling its use as a diagnostic product in Europe and other countries that recognize the European standard.

“Accurate, rapid, point-of-care testing will be critical to helping contain future Ebola and Lassa virus outbreaks,” said Robert Garry, Ph.D., professor of Microbiology and Immunology at the Tulane University School of Medicine. “This grant will help ensure that our consortium develops this diagnostic testing tool as quickly as possible.”

Current testing for the Ebola virus requires special biohazard handling and sending test samples long distances to special labs – a process that takes several days. This results in a critical loss of time to diagnose, treat and help prevent the spread of the virus. Development of the Corgenix Ebola test would enable rapid response to public health and bioterrorism threats posed by the deadly virus.

The Corgenix Ebola products are not currently cleared or approved by any regulatory authority for diagnostic use.

Monday, December 22, 2014

Arrayit Signs Cooperative R&D Agreement with the US Department of Agriculture to Develop Rapid Noroviruses and Foodborne Pathogen Detection Technologies

Arrayit Corporation announced that it has signed a Cooperative Research and Development Agreement (CRADA) with the United States Department of Agriculture (USDA) entitled "Rapid and Cost Effective Detection Technologies for Noroviruses and other Foodborne Pathogens." Under the terms of the agreement, Arrayit and the USDA Agricultural Research Service (USDA ARS) will develop and validate a rapid, portable, cost-effective and high-throughput detection system for the surveillance of multiple bacterial and viral foodborne pathogens including hepatitis, E. coli, Salmonella, Listeria, Campylobacter and Norovirus. The expected outcome is a commercial test that will be widely deployed throughout the lifecycle of food production and distribution to ensure that our food supply is safe for consumption.

The USDA seeks to expand economic opportunity through innovation to better nourish Americans by working cooperatively with the private sector. The USDA's $146 billion 2014 budget includes $123 billion of mandatory programs and $23 billion of discretionary spending for programs including food safety.

Arrayit and the USDA will utilize Arrayit's patented and proprietary DNA microarray platform and USDA's patent pending method to detect DNA sequences present in potentially life-threatening foodborne pathogens that periodically contaminate fruits, vegetables, meats, poultry and dairy products. According to the Centers for Disease Control and Prevention (CDC), foodborne illnesses afflict 1 in 6 Americans annually resulting in 128,000 hospitalizations, 3,000 deaths and more than $150 billion in economic losses.

Arrayit CEO Rene Schena states, "We are pleased to cooperate with the USDA to develop and commercialize rapid and cost-effective food safety surveillance based on Arrayit's widely used microarray technology and USDA's patent pending method. Deploying affordable, high throughput testing throughout food production and distribution will improve the quality of foods brought to market and further ensure public health and safety."

Quidel Receives Simultaneous FDA Clearance and CLIA Waiver for Its Sofia(R) Strep A+ Fluorescent Immunoassay (FIA) via the FDA's New Dual Submission Program

Quidel Corporation, a provider of rapid diagnostic testing solutions, cell-based virology assays and molecular diagnostic systems, announced that it has received marketing clearance and CLIA waiver by the United States Food and Drug Administration (FDA) for its Sofia Strep A+ Fluorescent Immunoassay (FIA) for the rapid detection of infections by Group A Streptococcus bacteria. These bacteria are the most common cause of bacterial pharyngitis and can also cause rheumatic fever and other potentially serious illnesses.

Sofia is the brand name for Quidel's next-generation, immunoassay system. The Sofia Analyzer and Sofia Strep A+ FIA combine unique immunofluorescence chemistry, advanced lateral flow technology, and failure alert and fail-safe systems designed to ensure reliable, objective, highly accurate, diagnostic results within five (5) minutes of application of the patient's specimen.

The linked-FDA clearance and CLIA waiver represent the first such achievement of any manufacturer under the FDA's new Dual Submission Program. This program requires a Pre-submission, and allows for simultaneous review of the 510(k) and CLIA waiver applications, substantially reducing the time and effort required for the FDA's review of 510(k) and CLIA waiver submissions that previously required two independent sequential submissions. Successful passage through the Dual Submission Program thus allows the diagnostic industry to pursue its commercial goals sooner, while also more quickly bringing new products to the marketplace where they can serve both physicians and patients.

The CLIA waiver designation for the Sofia Strep A+ FIA allows Quidel to sell the assay to all CLIA categories of laboratories in the United States, including the CLIA-waived segment of the market that is comprised of approximately 30,000 physician offices laboratories and 5,000 hospital emergency departments. It is anticipated that the clearance and CLIA waiver of the Sofia Strep A + FIA will further expand the placement of new Sofia instruments -- a process that has accelerated throughout 2014.

"We are pleased and very proud to receive the first joint clearance and CLIA waiver designation under the FDA's new Dual Submission Program. We can now provide our CLIA-waived customers with a highly accurate, quick and easy-to-use solution for the diagnosis of Strep A infections in our best-in-class Sofia format," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "Our customers love the Sofia platform, and because Strep A is our highest-volume product, we believe that our Sofia Strep A+ FIA has the potential to increase Sofia system installations and utilization well into 2015."

The Sofia Analyzer was 510(k) cleared in October of 2011, and Quidel's first Sofia FIA, the Sofia Influenza A+B FIA, received Clinical Laboratory Improvement Amendments (CLIA) waiver by the FDA in April of 2012. In addition to the Sofia Influenza and Sofia Strep A FIAs, Quidel also markets the CLIA-waived Sofia Respiratory Syncytial Virus (RSV) FIA and the Sofia hCG FIA. Quidel now provides a broad spectrum of FDA-cleared Strep A diagnostic assays that cover the full spectrum of market needs for this pathogen, including two assays on the Sofia platform (one CLIA-waived), three different assays on the QuickVue platform (two CLIA-waived), and two new molecular assays -- AmpliVue Strep A Assay and Lyra Direct Strep Assay (for Streptococcus pathogens of Groups A and C&G).

Roche Launches Next-Gen Viral Load Assay for CMV in Markets Accepting the CE Mark

Roche announced today the commercial availability of the cobas® CMV assay for use on the cobas® 6800/8800 Systems—further expanding the menu on the newest molecular diagnostic platforms from Roche. The new assay offers the exceptional performance that clinicians need when treating cytomegalovirus (CMV) infection in transplant recipients receiving anti-viral therapy.

"The unparalleled performance and unmatched flexibility of the cobas® 6800/8800 Systems allows laboratories to ensure rapid turn-around time for critical tests, like cobas® CMV, while still delivering routine viral load monitoring results," said Paul Brown, Head of Roche Molecular Diagnostics. "cobas® CMV is harmonized to the WHO standard to ensure that laboratories and clinicians can rely on this test, leading to increased quality of care and comparable results across different labs for patients infected with CMV."

This assay will be followed in the first quarter of 2015 by the cobas® HBV assay, completing the viral load monitoring portfolio for the cobas® 6800/8800 Systems. The cobas® 6800/8800 Systems, combined with the viral load assay portfolio, are designed to improve laboratory efficiencies while providing the rapid results needed to make informed treatment decisions.

The cobas® CMV assay and the cobas® 6800/8800 Systems are commercially available in markets that recognize CE-Mark and are not currently available in the United States.

About the cobas® 6800/8800 Systems

The cobas® 6800 and 8800 Systems are fully automated solutions designed for blood donor screening, viral load monitoring, women's health and microbiology testing. They are available in medium and high throughput models, respectively. Based on the Nobel-prize winning PCR technology, the systems are designed to deliver increased automation and throughput with shorter time to results, providing users with greater testing flexibility to increase overall workflow efficiencies.
The systems provide up to 96 results in less than 3.5 hours, and a total of 384 results for the cobas® 6800 System and 960 results for the cobas® 8800 System in an 8 hours shift.* Both systems allow for mixed batching, making it possible for labs to perform up to three tests in the same run with no pre-sorting required. The systems also enable up to eight hours (cobas® 6800) and four hours (cobas® 8800) of "work-away" time* with minimal user interaction.

Wednesday, December 17, 2014

U of T Engineering Team Delivers $1 Detection System for Measles and Rubella

U of T Engineering researchers have developed a paper-based diagnostic system for use in some of the world’s poorest countries. Awarded $112,000 by Grand Challenges Canada’s “Bold Ideas” initiative last month, the system is being touted for its potential impact on infant and maternal health in developing nations.

“Every hour, 11 infants are born with congenital rubella syndrome (CRS) and 18 children die of measles,” said researcher Alphonsus Ng (IBBME MASc 0T9, PhD Candidate), one of the lead designers of the technology.

Professor Aaron Wheeler (IBBME) and his team of researchers, including Ng, are developing a low-cost, portable system to detect measles and rubella infection status and immunity.

Using a small machine called the DropBot, health practitioners can run four concurrent tests on one droplet of blood. They insert a thin strip of paper, approximately one inch wide by three inches long, into a testing platform. Printed for less than a dollar by a standard ink jet printer, the paper has an innovative circuit-like design that actually generates light once the machine digitally manipulates the blood sample. The whole process takes 35 minutes.

In some of the world’s poorest nations, those 35 minutes could have life-changing impact.

Rubella—sometimes referred to as “German measles”—can be passed by pregnant mothers to their unborn children with devastating effects that can include severe developmental problems, blindness and stillborn births. The WHO estimates that approximately 110,000 children are born with congenital rubella syndrome (CRS) every year—but that statistic does not account for the number of women who miscarry or experience other pregnancy-ending complications from the disease.

“Vaccinating children is great,” explained Ng. “But the entire population still needs to be monitored, because there will still be vulnerable segments of the population, and that can lead to serious health risks.”

In the next 18 months, the team plans to test their technology on 200 patient samples in Vietnam.

“Vietnam is a hotspot for measles and rubella because they don’t have a common rubella vaccination yet,“ said Ng.

It’s also a country in dire need of diagnostic resources: Vietnam has only two diagnostic labs, one in the south and one in the north. Introducing a rapid, economical field diagnostic tool could have an enormous impact on this country of 97 million and lead to better-informed public health policies.

Testing the technology in the field will also allow the team to work on fine-tuning the technology specifically for the poorest nations.

“It costs us maybe a dollar to print the [paper] test chips, but printing these in an industrial setting would cut costs by another order of magnitude,” explained Ryan Fobel (IBBME PhD Candidate), one of the innovators behind the DropBot.

The team is also looking at ways to cut the cost of manufacturing the DropBot machine to a few hundred dollars, which would put the technology into far more hands, and potentially allow everything to be manufactured within the host country, generating local jobs.

“This is a great opportunity to bring digital microfluidics out into the field to address a real world problem,” said Wheeler. “I am proud to be working with such a motivated, enthusiastic team.”

Vivione Biosciences Announces Successful Completion of Its Early-Stage Pilot Study at the Cleveland Clinic

Vivione Biosciences Inc. is pleased to announce the successful completion of its early stage pilot study at the Cleveland Clinic focused on applying its RAPID-B bacterial detection platform to the primary screening of suspected urinary tract infections (UTIs).

"While our primary goal was to gather substantial data on clinical samples for later modification of the system's software algorithms, it was clearly evident from the first day forward we could accurately detect clinically defined UTIs at the time the sample arrived in the lab, in essence 18-24 hours faster than traditional methods," said Chief Medical Officer, Dr. Matthew Gombrich. "Our next phase will expand on the 100% sensitivity seen in this evaluation to determine the clinical specificity of the system in a larger clinical context," Gombrich continued.

"This is once again proof that RAPID-B has a place not only in the Food Safety sector, as was demonstrated by our AOAC approvals, but in the clinical realm as well. We're thrilled by these preliminary results and look forward to expanding the data for regulatory approval and commercializing the product for rapid, high sensitivity bacterial screening in the clinical setting. NIH estimates there are over 500,000 hospital-associated UTIs annually and we feel the RAPID-B system will offer an excellent means to both diagnose and lower costs associated with the disease," said Kevin Kuykendall, CEO of Vivione Biosciences.

The Vivione's RAPID-B platform, which is currently commercialized in both the Food Safety and the Oil and Gas sectors, is a highly sensitive and rapid platform for detecting bacteria in complex matrices (like beef or frac water). Vivione is currently applying the system not only to urinary tract infection screening but blood infections and meningitis screening as well. Vivione has also recently filed IP focused around rapid antibiotic susceptibility determination using the RAPID-B platform.

Tuesday, December 16, 2014

FDA Grants CLIA Waiver Expanding the Availability of Rapid Screening Test for Syphilis

The U.S. Food and Drug Administration today announced that it granted the first-ever waiver, under certain laboratory regulations, for a rapid screening test for syphilis, which will allow the Syphilis Health Check test to be used in a greater variety of health care settings.

According to the U.S. Centers for Disease Control and Prevention (CDC), about 55,000 people in the United States are newly infected with syphilis annually. During the 1990s, syphilis primarily occurred among heterosexual men and women of racial and ethnic minority groups; during the 2000s, however, cases increased among men who have sex with men (MSM). Men who have sex with men accounted for 75 percent of all primary and secondary syphilis cases in 2012.

This sexually transmitted infection, caused by the bacterium Treponema pallidum, can cause long- term complications or increase the likelihood of HIV transmission if not adequately treated. The syphilis bacterium can also infect the fetus of a woman during her pregnancy, causing infant death, developmental delays and seizures. CDC recommends that all pregnant women be tested for syphilis at the first prenatal visit. Those who are at high risk, live in areas with high rates of syphilis or were previously not tested should be tested in the third trimester and again at delivery. CDC also recommends screening at least once a year for syphilis for all sexually active homosexual, bisexual, and other men who have sex with men.

The FDA’s waiver is related to the Clinical Laboratory Improvement Amendments (CLIA), federal standards that apply to clinical laboratory testing on humans, with certain exceptions. Because the FDA granted a waiver under CLIA, the Syphilis Health Check test can be distributed to a variety of nontraditional laboratory sites, including physicians' offices, emergency rooms, maternity wards, other health care facilities, health department clinics, outreach sites, community-based organizations and other freestanding counseling and testing sites. The waiver also allows untrained health care workers to perform the tests on patients.

“The broader availability and easier access to this test should contribute to a higher rate of detection of syphilis infection,” said Alberto Gutierrez, Ph.D., director of the Office of In VitroDiagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health.

The test is performed by obtaining a sample of whole blood from a finger stick. Results are available in as little as 12 minutes and may be performed in the presence of the patient. All positive tests should be followed up with further syphilis serological laboratory testing and clinical evaluation before final diagnosis. The rapid result means that if a patient tests positive, a health care worker can obtain a second blood sample at the same office visit to confirm the test results through further lab testing. This increases the probability that patients, who might not return for a follow-up visit, will receive timely treatment.

The FDA first cleared the Syphilis Health Check test in 2011 and categorized it under CLIA as moderate- and high-complexity. The type of CLIA certificate a laboratory obtains depends upon the complexity of the tests it performs. CLIA regulations describe three levels of test complexity: waived tests, moderate complexity tests, and high complexity tests. The test was intended for use by prescription only to detect Treponema palladium antibodies in serum, plasma, and human whole blood.

The FDA granted a waiver under CLIA for the Syphilis Health Check test after the manufacturer submitted data demonstrating the test’s ease of use and accuracy. The agency reviewed data for finger sticks of whole blood samples from 417 subjects collected over the course of four months at three testing sites representing typical CLIA-waived sites, such as doctor’s offices. Twelve individuals not trained in the use of the Syphilis Health Check test performed the tests on the study subjects. Results showed that the Syphilis Health Check test, when used by untrained operators, performed with high accuracy. This is critical if the test is to be allowed for use outside of moderate- and high-complexity laboratories.

With the issuance of the waiver, the Syphilis Health Check test can be used by more laboratories as an initial screening test or in conjunction with other appropriate laboratory tests and clinical findings to aid in the diagnosis of syphilis infection. However, the test is not intended for use in screening blood or plasma donors.

The Syphilis Health Check test is manufactured by VEDA LAB of Alencon, France for Diagnostics Direct, LLC, based in Cape May Court House, New Jersey. It is also distributed by Trinity Biotech USA, Inc., of Jamestown, New York.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Monday, December 15, 2014

Fio Intelligent Devices to Automate Ebola Rapid Test Reading and Data Capture

Fio Corporation today announced that it has received a grant financed by the Bill & Melinda Gates Foundation to adapt its Fionet™ solution to connect rapid diagnostics and data in the fight against Ebola.

“In an outbreak, it is crucial for health workers to capture data at point of care — if health workers don’t get that data, no one gets that data. It’s equally crucial to treat immediately, on first encounter with the patient — but you can’t treat what you haven’t diagnosed,” said Dr. Michael M. Greenberg, Chairman and CEO at Fio. “Fionet fuses automated data capture with on-the-spot diagnostics. The Gates Foundation is accelerating our capability to be of service in the Ebola crisis.”

By integrating intelligent mobile devices for diagnosis, treatment, and data capture with cloud-based information services, Fionet will deliver complete, reliable data within minutes from frontline health workers to remote health managers and organizations responding to the Ebola outbreak.

Automatically reading Ebola rapid tests and connecting it all to the cloud

Only 18 laboratories in West Africa currently have the capacity to test suspected Ebola cases — four in Guinea, nine in Liberia, and five in Sierra Leone It can take days for blood samples to be transported to these centres from patients at triage, and for results to return. Further exacerbated by weak infrastructure, this can mean days in quarantine waiting to get results, increasing the chance of infecting, or being infected by, others.

Several companies are working to bring to market rapid diagnostic tests that can reliably detect Ebola within minutes from a pinprick of blood or sample of saliva. Grant funding will make it possible for Fio’s Deki™ Reader to objectively analyze results from these tests and then immediately transmit results and case reports to the Fionet database.

Patients will get results right away, so they can be instantly isolated, released, or tested for other causes of illness. All this frontline data, available to remote managers via secure online access, will help them make significant gains in containment. In real time, managers will be able to monitor the epidemic, identify hot spots, direct scarce resources and supplies to where they’re most needed, and track potentially infected contacts of patients.

Closing the gap between frontline reality and response

For every new case of Ebola, health workers must track down every person who was in contact with that patient during the preceding days and weeks. Those contacts must then be closely monitored for signs of illness. This is usually accomplished by recording data on paper forms, which are transported to data-entry centres and entered into an electronic database. Even one missed contact can keep the outbreak going.

Grant funding will contribute to the enhancement of Fionet mobile software to supplant this cumbersome process with digital data collection. Health workers will be able to instantly feed contact tracing data to Fionet via smartphones and tablets, reducing time lag between data captured in the field and response. With real-time access to interactive network maps of contacts, managers will be able to quickly identify others who might be infected and begin to arrest transmission.

Lasting value for health system strengthening in West Africa

Many West Africans suffering from diseases other than Ebola, but which also cause fever, are not being treated while awaiting Ebola test results. Fio’s Deki Reader, which will be configured to read Ebola tests, is already CE-marked for use with rapid diagnostic tests that detect malaria and dengue, two common causes of fever in West Africa.

“After adapting Deki Readers and Fionet to combat Ebola, this same technology will leave the health systems in West Africa better prepared to manage future outbreaks, as well as existing endemic diseases,” said Ian Fine, Fio’s Chief Technology Officer.

Sunday, December 14, 2014

Abbott Pathogen Detection Platform Obtains CE Mark

Abbott has announced its innovative diagnostic platform, known as IRIDICA, is now available in Europe and other CE-Mark recognized countries. The new platform can identify more than 1,000 infection-causing pathogens in less than six hours, versus the current standard of care (culture-based testing), which can take days. By identifying the cause of infections – such as bacteria, viruses or fungi – sooner, doctors can improve care for the critically ill.

Previously called Plex-ID, the next generation platform debuted in July, and has been praised for its ability to detect and identify pathogens that are rare or difficult to grow in culture.

"Doctors need better tools to diagnose people with serious infections," said Professor François Simon, M.D., Ph.D., Chief of Microbiology at Hôpital Saint-Louis, Paris, France. "For those with sepsis, the survival rate decreases each hour treatment is delayed. Often times, it’s because current tools cannot identify the source of infection in time for doctors to treat with the appropriate therapies."

IRIDICA uses a combination of sophisticated testing technologies known as Polymerase Chain Reaction/Electrospray Ionization Mass Spectrometry (PCR/ESI-MS) to rapidly identify infection-causing pathogens directly from a patient’s sample, without the need for culture. According to Abbott’s RApid Diagnosis of Infections in the CriticAlly IlL (RADICAL) study results, the technology was able to detect pathogens when the current standard of care did not. In the study, after retrospectively comparing the results of Abbott’s technology versus culture, an independent panel of physicians[i] reported it would have prescribed a different course of treatment in nearly 60 percent of cases evaluated. Additionally, analysis of the study results suggested that Abbott’s technology could help lower associated health care costs by 30 percent and reduce hospital stays for people with serious infections by up to eight days.

"Currently, when a person enters a hospital with a suspected infection, it may take several days before the source can be accurately identified, which can delay appropriate treatment," said David J Ecker, Ph.D., divisional vice president, R&D for Abbott’s Ibis Biosciences business. "IRIDICA can offer a better and faster way to detect and identify pathogens that cause serious infections and aid physicians in diagnosing and managing the critically ill."

IRIDICA also represents a step forward in the effort to combat the overuse of antibiotics. According to the World Health Organization (WHO), the overuse and misuse of antibiotics have driven the rise of antibacterial resistance, which is considered an increasingly serious threat to public health.

"Slower diagnostic methods, like cultures, have led to the overuse of broad-spectrum antibiotics and antimicrobials and an emergence of new resistant superbugs," said Jean-Louis Vincent, M.D., Ph.D., Professor of Intensive Care, Université Libre de Bruxelles, Belgium. "By identifying pathogens faster with IRIDICA, a doctor can quickly prescribe the most effective therapy, potentially limiting the indiscriminate use of broad-spectrum antibiotics."

IRIDICA currently offers five testing panels for pathogens that cause infections in the critically ill such as sepsis; other bacterial, fungal and viral infections; and ventilator-associated pneumonia.

Rapid Ebola Test Is Focus of NIH Grant to Rutgers Scientist

A Rutgers researcher has received a grant of nearly $640,000 from the National Institutes of Health to develop a rapid test to diagnose Ebola as well as other viruses that can cause symptoms similar to Ebola.

David Alland, a professor of medicine and associate dean for clinical research at Rutgers New Jersey Medical School – and the principal investigator for the project – says health workers would be able to take the test to small villages and other remote locations where the spread of Ebola has been especially rampant and diagnose patients where they live.
The test could be used wherever electricity is available, including power from car batteries, according to Alland. “That means diagnosis would take significantly shorter than the time it takes to get a test result now from a medical lab,” he says.

Alland, working with the California biotechnology company Cepheid, hopes to develop the test within the next 15 months – using genetic material from Ebola and other viruses that cannot cause or spread disease. Work in Alland's laboratory will not involve the use of live virus.

Alland and Cepheid previously used technology similar to the planned Ebola test to develop a rapid test for tuberculosis (TB) that is now widely used in impoverished areas of the world.

Photo: John Emerson
Researchers will adapt this cartridge, now used worldwide for tuberculosis screenings, to collect and test samples from potential Ebola patients.

The TB test on which the new diagnostic will be modeled was endorsed by the World Health Organization for worldwide use in 2010 and approved by the Food and Drug Administration last year for use in the United States. That test employs a small cartridge where a sample of a patient’s sputum is placed, which is then loaded into a machine for analysis. The result is available within two hours.

Alland says the Ebola test would employ a modified form of the TB cartridge while using the same machine to analyze small amounts of patients’ blood or samples taken from cheek swabs.
“The beauty of this approach is that there’s already a substantial supply of these instruments in developing countries because of the tuberculosis tests, so we can piggyback,” Alland points out. Cepheid, which markets the TB test, says more than 3,500 of the systems are now in use in the developing world.

As they produce their test for the Ebola virus, Alland and Cepheid also plan to create rapid diagnostic tests for other viral illnesses including chikungunya – a painful mosquito-borne disease that, according to the CDC, sickened more than 140 people in New Jersey this year after those people had visited tropical regions in the Caribbean and Asia and islands in the Pacific.

Along with their importance in the developing world, tests that can rapidly and accurately diagnose Ebola and other illnesses may have great value for modern hospitals in the West.

“Hospitals lose both time and money because they often need to isolate patients who might have infectious diseases,” says Alland. “The sooner health professionals can be confident about patients’ disease status, the sooner those patients can receive necessary treatment if they are infected – or be released if they are not.”

Saturday, December 13, 2014

Quidel Receives FDA Clearance for Its AmpliVue® Hand-Held Molecular Diagnostic Test for Bordetella Pertussis

Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced that it has received clearance from the United States Food and Drug Administration (FDA) to market its AmpliVue Bordetella Assay for the detection of Bordetella pertussis nucleic acids isolated from nasopharyngeal swab specimens obtained from patients suspected of having a respiratory tract infection attributable to Bordetella pertussis.

Pertussis, or whooping cough, is a very contagious disease caused by the Bordetella pertussis bacteria, which attach to the cilia that line part of the upper respiratory tract where they cause inflammation. [1] Pertussis is spread from person to person through the inhalation of bacteria from an infected person's cough or sneeze. Symptoms, such as a runny nose, low-grade fever, or mild cough usually develop within 5-10 days after exposure, but sometimes appear as long as 3 weeks later. Although whooping cough can cause serious illness in children and adults, it is most dangerous for infants and babies. According to the Centers for Disease Control and Prevention (CDC), about half of infants younger than 1 year of age who get this disease require hospitalization. [2]

The incidence of pertussis has risen steadily over the last few years. [3] Factors that have likely contributed to the increased incidence of pertussis include a decline in vaccine use, waning vaccine-induced immunity in adolescent and adult populations, failure to receive booster shots later in life, and continued circulation of B. pertussis in our population. [4-5]

The AmpliVue Bordetella Assay is an easy-to-use, self-contained, handheld disposable molecular diagnostic test with superb clinical accuracy. The assay requires no upfront extraction of DNA and generates an accurate result in approximately 75 minutes. Like all FDA-cleared AmpliVue assays, the AmpliVue Bordetella Assay is CLIA-classified [6] as moderately complex and does not require the customer to invest in expensive thermocycling equipment. This benefit, plus less laboratory space requirements, can significantly lower a laboratory's cost when adopting new molecular testing methods.

"We are pleased to receive 510(k) clearance for our AmpliVue Bordetella Assay -- our fifth assay in the AmpliVue format. We've shown that we can harness our proprietary HDA technology to develop fast, accurate molecular diagnostic assays with a menu that matters to our customers," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "Longer-term, we intend to leverage this technology for other molecular diagnostic applications that will be appealing to significant market segments and potentially to public health agencies worldwide."

Quidel's AmpliVue platform now enables laboratories of all sizes to perform highly sensitive and specific molecular tests. The AmpliVue Bordetella Assay expands to six (6) the list of detectable analytes for which this novel AmpliVue platform now has FDA clearance. These include Pertussis, C. difficile, Group A Strep, Group B Strep, HSV1 and HSV2.

3) CDC. Provisional Pertussis Surveillance Report. 2013.
4) Versteegh FGA, Schellekens JFP, Fleer A, Roord JJ. Pertussis: a concise historical review including diagnosis, incidence, clinical manifestations and the role of treatment and vaccination in management Rev Med Microbiol 2005; 16 (3): 79-89.
5) Atwell JE, Van Otterloo J, Zipprich J, Winter K, Harriman K, Salmon DA, Halsey NA, Omer SB. Nonmedical vaccine exemptions and pertussis in California, 2010. Pediatrics 2013; 132 (4): 624-30.
6) Clinical Laboratory Improvement Amendments of 1988 (CLIA).

STMicroelectronics, Clonit, and Institute Spallanzani Develop Accurate Point-of-Care Analyzer for Early Ebola Detection

Driven by the ambitious objective to quickly detect the Ebola virus in the blood at a very early stage to minimize further transmission, STMicroelectronics and Clonit, in collaboration with Italy's National Institute for Infectious Diseases Lazzaro Spallanzani, have developed, in a few weeks' time, a prototype portable analyzer able to identify the presence of the Ebola virus in less than 75 minutes.

The portable analyzer is based on the Real-Time Polymerase Chain Reaction (RT-PCR) molecular biology technique. The next step in development of the analyzer is to optimize the point-of-care Ebola-detection solution for large-scale deployment, including minimizing the threat of infection during the handling of the biological sample and lowering costs. This effort paves the way for enabling rapid diagnostic tests for Ebola as well as many other viruses that are much more widespread.

The prototype analyzer kit has been successfully tested for compliance with applicable international standards by the National Institute for Infectious Diseases Spallanzani, one of the two Italian institutions designated by the Italian Ministry of Health as a reference center for care and treatment of Ebola. The kit detects the presence of the Ebola virus with extreme accuracy in just a few microliters of human-blood samples and the accuracy of the result has been confirmed with a blood sample diluted up to a million times. The high sensitivity of the test allows the detection of the virus at a very early stage, which can significantly help limit the spread of the deadly disease.

The kit consists of four main components:

  • An extractor, on which the blood sample is loaded to extract the virus RNA ;
  • A stamp-sized silicon microchip, developed by STMicroelectronics' labs in Agrate Brianza and Catania, which acts as a miniaturized reactor and reproduces, in a micrometer scale, the entire process of amplification and screening of the extracted genetic material on which the extracted RNA is loaded, to be then reverse-transcribed into DNA and amplified according to the RT-PCR methodology.
  • Specific reagents, developed by Clonit, that are pre-loaded on the microchip to perform a Quantitative Real-Time PCR (viral load) in compliance with all standards and controls required by the international quality-control regulations;
  • A portable optical reader, also developed by STMicroelectronics, which detects the presence of viral DNA in the sample and sends the data to a PC that processes and presents them in graphical form.
  • In addition to accuracy, the speed and small size of the solution makes it very useful in urgent situations and for "field" diagnostics.

"This test will have important consequences for both medicine and public health," underlined Giuseppe Ippolito, Scientific Director at the Spallanzani Institute. "In fact, a quick diagnosis leading to the identification of patients with Ebola would result in the immediate implementation of isolation measures, thus reducing the risk of spread of infection in the community and enabling the immediate start of an appropriate treatment for the patient."

"With the development of this technique, the Institute once again meets the need of the scientific community and of the country to develop key technologies to cope with infectious diseases," added Valerio Fabio Alberti, Special Commissioner, at the Spallanzani Institute.

"We are proud to put our innovative capabilities and deep technology portfolio at the service of humanity and to bring our contribution to the fight against a serious epidemic that could threaten the entire world population," said Andrea Cuomo, Corporate Vice President, Advanced Projects, STMicroelectronics. "Once again, STMicroelectronics' Research demonstrates its capabilities for opening new opportunities for the microelectronics world."

"I consider this achievement of the Italian biomedical research an excellent example of collaboration between public and private organizations," noted Carlo Roccio, Clonit Chief Executive Officer.

Now the partners, in collaboration with other industry leaders in this field, are evaluating an integrated, completely self-contained, and fully automated disease-detection system capable of performing multiple analyses in parallel on a large number of samples. Time optimization, along with portability, automation, and integration will allow further cost reductions and produce a more efficient process with human intervention limited to sample taking, paving the way to affordable screening of Ebola and other viruses.

"The brilliant results of this cooperation stimulate our Institute to more vigorously pursue its mission to promote the development and validation of new technologies, in addition to testing the transfer of these new technologies into the national health system," concluded Valerio Fabio Alberti of the Spallanzani Institute.

Friday, December 12, 2014

Rapid Micro Biosystems Announces Availability of Bi-Directional LIMS Integration

Rapid Micro Biosystems, a leading provider of automated, non-destructive, rapid microbial detection, today announced the general availability of two-way integration to laboratory information management system (LIMS) through its industry leading Growth Direct™ System. The new capability allows quality control microbiology labs to save time and reduce errors associated with entry of final test results of environmental monitoring, bioburden and sterility tests.

The bi-directional LIMS integration uses widely supported comma-separated (CSV) files to communicate, allowing integration with most LIMS systems. Due to the flexibility provided by the communication method, integration is flexible and can be aligned to the specific needs of the quality control microbiology lab both initially and in the future.

The integration supports the use of LIMS or Growth Direct created barcodes that are applied to Growth Direct Cassettes. After sampling, the cassettes are loaded into the Growth Direct System, which performs the incubation, detection and enumeration of colonies. Final results are automatically uploaded to the LIMS system. This eliminates the need for microbiologists to manually count plates and key the colony forming unit (CFU) values into the LIMS system, reducing the chance of a keying error.

"Our two-way LIMS capabilities will not only save time, but will help reduce errors in the QC lab," said Julie Sperry, Rapid Micro Biosystems' Chief Commercial Officer. "The new functionality will help labs move closer to becoming paperless."

Neogen Acquires Assets of its Chinese Distributor

Neogen Corporation announced that it has acquired the food safety and veterinary genomic assets of its Chinese distributor, Beijing Anapure BioScientific Co., Ltd. (Anapure).

Anapure has been a distributor of Neogen’s food safety products for more than 10 years, and has also offered Neogen’s veterinary genomic services in recent years.

“As we’ve shown with our acquisitions of successful distributor partners in Europe, Brazil, and elsewhere, creating a direct presence in an important global market can accelerate our expansion into that market,” said James Herbert, Neogen’s chairman and chief executive officer. “China’s burgeoning middle class, with its rapidly growing demand for higher quality meat and dairy products, makes the country a substantial growth opportunity for Neogen products — both for animal production on the country’s farms, and in processing plants throughout China’s food processing and distribution industry.

“Acquiring these strategic assets from Anapure will give us direct access to the western and multinational food companies that have located in China, most of which are already Neogen customers elsewhere,” Herbert continued. “The acquisition will also allow us to build upon our existing Neogen China infrastructure to provide a foothold in Asia, from which we will be able to expand throughout the region.”

Anapure was founded in 1998, and has focused on food and environment safety testing, blood typing, and small animal disease diagnosis throughout China. Its food safety testing business includes more than 700 customers in the dairy, beverage and beer, animal feed, and meat and poultry industries.

Terms of the deal were not disclosed.

Neogen Corporation develops and markets products dedicated to food and animal safety. The company’s Food Safety Division markets dehydrated culture media, and diagnostic test kits to detect foodborne bacteria, natural toxins, food allergens, drug residues, plant diseases and sanitation concerns. Neogen’s Animal Safety Division is a leader in the development of animal genomics along with the manufacturing and distribution of a variety of animal healthcare products, including diagnostics, pharmaceuticals, veterinary instruments, wound care and disinfectants.

U.S. Food and Drug Administration Grants CLIA Waiver for Alere Determine™ HIV-1/2 Ag/Ab Combo Test

Alere Inc., a global leader in rapid diagnostic tests, announced that the U.S. Food and Drug Administration (FDA) has granted CLIA (Clinical Laboratory Improvement Amendments) Waiver for the Alere Determine™ HIV-1/2 Ag/Ab Combo test. Until now, the test has been available for sale in the United States to health facilities and laboratories licensed to conduct tests of moderate complexity. With this approval, the test will now be available for use in physician offices, clinics and other public health settings as well.

Alere Determine HIV 1-2 Ag/Ab Combo was FDA-approved in August 2013 as the first fourth-generation, rapid point-of-care test that detects both HIV-1/2 antibodies and free HIV-1 p24 antigen. Due to its capability to detect p24 antigen, which can appear in only days after infection and before the HIV antibody is detectable, Alere Determine HIV-1/2 Ag/Ab Combo may detect HIV infection earlier in the course of the disease. Earlier detection allows healthcare providers to improve clinical outcomes through earlier diagnosis and treatment of patients who test positive for HIV.

"CLIA Waiver of the Alere Determine HIV-1/2 Ag/Ab Combo will help facilitate accurate and early detection of HIV, which is critical to stemming the spread of HIV/AIDS in the United States, and will have a positive economic impact by bringing a critical healthcare service nearer to patients," said Avi Pelossof, Global President of Infectious Disease at Alere. "Broadening the test's availability to laboratories, physician offices, clinics and other public health settings, advances Alere's commitment to delivering reliable and actionable information through rapid diagnostics."

"I'm excited to learn that Alere Determine HIV-1/2 Ag/Ab Combo has been granted CLIA waiver and will be available for broader use in HIV screening," said Eugene Martin, Ph.D., Professor of Pathology & Laboratory Medicine at Rutgers University – Robert Wood Johnson Medical School and the Co-Director of NJ HIV, the Rapid HIV Test Support Program. "The promise of a fourth-generation, rapid HIV test is one that we all look forward to since it will allow screening locations to potentially identify early HIV infections, and to steer those who are most at risk of infecting others into treatment sooner."

According to the Centers for Disease Control and Prevention (CDC), there are approximately 1.1 million Americans living with HIV, and an estimated 180,900 (15.8%) whose infections have not been diagnosed. In 2011, the CDC estimated that there were 49,273 newly infected people with the virus in the United Sates, indicating that HIV remains a serious health problem. HIV testing is essential for healthcare and social services to improve the quality of life and survival for persons who have HIV.

Health Canada Extends DuPont™ BAX® System Certification for E. coli O157:H7 Testing

The Health Canada Microbiological Methods Committee has extended its approval of the DuPont™ BAX® System Real-Time PCR Assay for E. coli O157:H7 in the Compendium of Analytical Methods: Laboratory Procedures for the Microbiological Analysis of Foods. The BAX® System assay, published in the Compendium as MFLP-76, is now approved for testing composited samples of ground beef weighing up to 375 g.

Originally approved by Health Canada in April 2011, the BAX® System Real-Time PCR Assay for E. coli O157:H7 provides users with a rapid screening method for detecting E. coli O157:H7 – including non-motile strains and other atypical O157:H7 variants – in individual 65 g samples of raw ground beef and 375 g samples of raw beef trim. With this extended method approval, users also can elect to composite multiple ground beef enrichments into a single, larger sample before testing to quickly identify negative samples, greatly increase testing throughput and reduce the overall cost per test.

“Customers who perform a large number of pathogen tests every day – such as service laboratories and corporate testing labs – value a detection system that maximizes sample throughput and offers the greatest level of flexibility,” said Kathy Wilson, Canadian business manager, DuPont Nutrition & Health Diagnostics. “With the addition of composite sample testing as an approved protocol in the Compendium of Analytical Methods, we are proud to announce that the BAX® System can provide our customers with this additional time-, labor- and cost-saving alternative for ground beef testing in accordance with Health Canada regulations.”

Food processing companies around the world rely on the award-winning BAX® System to detect pathogens or other organisms in raw ingredients, finished products and environmental samples. The automated system uses leading-edge technology, including PCR assays with tableted reagents and optimized media, to detect Salmonella, Listeria species, Listeria monocytogenes, E. coli O157:H7 and STEC, Campylobacter, Staphylococcus aureus, Vibrio, and yeast and mold.  Many of these tests have been certified by AOAC and AFNOR and/or approved by government agencies in the Americas, Asia and Europe.

Rapid Microbiological Water Tester Wins ‘Product Innovation in Healthcare’ Category at IHEEM Awards

IDEXX Water (UK) , the global leader in rapid microbiological water testing, today announced that its Pseudalert test, for the 24 hour detection of Pseudomonas aeruginosa (P. aeruginosa), won the prestigious ‘Product Innovation in Healthcare’ Award at the Institute of Healthcare Engineering and Estate Management’s (IHEEM) annual Exhibition, Conference and Dinner, which took place in Manchester, UK, on the 7th and 8th October 2014. IHEEM is the UK's largest specialist Institute for the Healthcare Estates Sector, devoted to developing careers, provision of education and training, and registering engineers as Eng Tech, IEng and CEng.

The Awards recognise the work and commitment to excellence by public and private healthcare providers. The judging panel, which was made up of industry experts in healthcare and facilities management, awarded the top honour for innovation to Pseudalert, which uses a novel Bacterial Enzyme Technology to identify P. aeruginosa, giving either a presence/absence, or quantified result in 24 hours, less than half the time taken by traditional membrane filtration (agar based) methods.

Other companies shortlisted in the ‘Innovation’ category included Armitage Shanks, Bender UK, Britplas, Discrete Heat Co Ltd, Danfloor and Finegreen Associates.

IDEXX introduced the Pseudalert test into the UK healthcare sector earlier this year, to facilitate the rapid detection and identification of P. aeruginosa in hospital water systems. In areas where patients are most vulnerable to P. aeruginosa infection, such as high dependency units, neo-natal departments and burns wards, any ambiguity or delay in results, is potentially serious.

“We are deeply honoured to receive this recognition from the IHEEM judges, especially in view of the strength of the entries in this category,” commented Andrew Headland, Senior Business Manager, for IDEXX EMEA. “The award for Pseudalert is particularly pleasing as it illustrates that the health industry acknowledges the importance of rapid and regular P. aeruginosa testing in healthcare environments.”

Pseudalert is a well established method for rapid detection of P. aeruginosa in tap water, bottled water, pools and spas. The launch of Pseudalert in the healthcare sector comes after IDEXX completed a Pan European study in 2014 demonstrating that the product was suitable for use for this application. In June 2014, a statement was issued by IDEXX informing hospitals and facilities management organisations that Pseudalert is now compliant with the requirements of the HTM04 guidelines for hospital water testing.

The simplicity of IDEXX water testing solutions has seen other products widely adopted in testing laboratories around the world. Where access to microbiology laboratories is restricted, such as on cruise ships, oil rigs and even the International Space Station, IDEXX technologies have also been used.

Cepheid’s Xpert Norovirus Test Gets Green Light from FDA

Cepheid, a molecular diagnostics company, recently received clearance from the U.S Food and Drug Administration to market its Xpert Norovirus test.

The diagnostic test provides rapid diagnosis of Noroviruses in genogroup I and genogroup II.

“Norovirus exposure is an unfortunate fact of life,” Cepheid Chairman and CEO John Bishop said. “The associated illness can spread quickly in the hospital setting and be very serious, especially in young children and older adults. To actively manage the infection, clinicians have previously been forced to choose between accuracy and time-to-result when selecting a testing method — now, no compromise is required as Xpert Norovirus delivers both.”

Norovirus is a highly contagious virus and is the most common cause of viral gastroenteritis worldwide. Afflicting an estimated 21 million people annually, Norovirus is transmitted by contact with contaminated food and water, infected persons or contaminated surfaces.

“Xpert Norovirus enables on-demand molecular detection and differentiation of the GI and GII Norovirus genogroups, which together account for the vast majority of human infections,” Dr. David H. Persing, chief medical and technology officer at Cepheid, said. “Norovirus outbreaks require immediate implementation of targeted infection control procedures and this new test gives clinicians accurate results in as little as one hour.”

The Xpert Norovirus tests will begin shipping within the United States this month.

Wednesday, December 03, 2014

Ceres to Develop New Method for Detecting the Presence of Ebola Virus in Saliva

Ceres Nanosciences Inc. (Ceres) today announced the commencement of a development program, funded by the Gates Foundation, to use Ceres' Nanotrap® particle technology to develop a new method of detecting the presence of the Ebola virus in saliva. During the four-month performance of this program, Ceres will work in close collaboration with George Mason University and the United States Army Medical Research Institutes of Infectious Diseases (USAMRIID) to assess the ability of the Nanotrap technology to develop a more sensitive and safer Ebola virus detection method that uses saliva instead of blood.

Ceres, a biotechnology company located in Northern Virginia, has developed and commercialized a novel nanoparticle technology, the Nanotrap®, which provides powerful biofluid sample processing capabilities for a wide array of diagnostic applications and sample handling needs.

The Nanotrap technology was invented at George Mason under funding from the National Institutes of Health (NIH) for biomarker discovery applications and is being developed into commercial products by Ceres with continuing support from NIH, Defense Advanced Research Projects Agency, the Department of Homeland Security and the Commonwealth of Virginia.

The combined team of Ceres, Mason and USAMRIID will bring forward world-class research capabilities and resources to execute this project on a rapid schedule to address the dire need for better testing methods for Ebola.

"Detection and confirmation of the Ebola virus is limited by issues inherent in collecting blood samples for testing," says Ross Dunlap, CEO of Ceres. "These include exposure risk, lack of adequately trained personnel, sample storage requirements, and, in some cases, cultural objections toward blood collection. The potential increased sensitivity afforded by Nanotrap sample processing in saliva could enable safer, earlier and more accurate detection and response during an outbreak."

"The effective detection of Ebola, using a noninvasive sample collection method, such as saliva collection, coupled with a highly sensitive diagnostic test, all enabled by our Nanotrap particle technology, presents a very compelling solution for rapid identification of infected individuals at an earlier stage of infection," says Emanuel Petricoin, codirector of the Center for Applied Proteomics and Molecular Medicine at Mason and cofounder of Ceres.

Tuesday, December 02, 2014

IDT and Ubiquitome Partner to Develop Mobile Ebola Test

Integrated DNA Technologies (IDT), and Ubiquitome today announced a partnership to develop the Ubiquitome Freedom4 Real-Time RT-PCR Ebola Virus Assay for easy use in the field. This rapid test is designed to be run on Ubiquitome’s hand-held, battery powered real-time PCR device, the Freedom4.

IDT, a market leader in the manufacture of GMP quality products for use in molecular diagnostic tests, is leveraging its PrimeTime qPCR Assay platform to develop an assay that will provide accurate and consistent test results for Ebola virus disease.

Fitting in the palm of a hand, Ubiquitome’s Freedom4 instrument operates on battery power alone for up to six hours and delivers gold-standard real-time PCR performance wherever needed. The platform runs using an iPhone or laptop computer, is housed in a rugged aluminum casing and features a solid state design that includes laser-based optical detection, which is widely recognized as offering the highest performance in real-time PCR.

Paul Pickering, Ubiquitome CEO, said “The Ubiquitome Freedom4 Real-Time RT-PCR Ebola Virus Assay, run on the Freedom4, will allow rapid, accurate field testing of Ebola virus disease. This is important because regions affected by this disease are often far from an established laboratory.”

Stephen Gunstream, Chief Commercial Officer of IDT added, “The sensitivity and specificity of our PrimeTime qPCR Assays are well established. We are excited about how effectively we can combine IDT’s assay design expertise with Ubiquitome’s Freedom4 instrument to provide a field testing service for Ebola virus disease. This test will enable early detection and help control the spread of this devastating disease.”

Testing of the Ubiquitome Freedom4 Real-Time RT-PCR Ebola Virus Assay will be conducted by Battelle in Aberdeen, Maryland, USA.

Irish Luxcel Biosciences Develops “Game-changing” Rapid Method for Milk and Dairy Products

Luxcel Biosciences, with partners MOCON and Oculer, have developed a platform of rapid microbiology testing products that aim to improve global quality and hygiene programmes in milk and dairy production.

The series of tests, which can deliver same-day results, assess the quality of the milk right through the supply chain, from the dairy parlour to the finished product, and aims to target the world’s increasing demand for milk, which is expected to rise to 350bn litres in 2020.

Founded by Dr Richard Fernandes and Prof Dmitri Papkovsky, Luxcel Biosciences has operated from Cork as a spin-off company from University College Cork (UCC) to develop technology to monitor the growth and viability of cells for food, beverages and pharmaceutical safety.

Luxcel optical sensing technology monitors the ability of the bacteria to grow in the liquid milk itself, or in the milk powder, and claims to be a faster and more sensitive testing solution than standard technologies and makes up for the current standard’s downfalls.

Papkovsky explained how the new tests work. “Based on a patented and highly sensitive optical oxygen sensor technology developed by Luxcel Biosciences, the new easy-to-use GreenLight and Oculer tests provide highly sensitive and rapid measurement of micro-organisms that grow in the neat milk, causing spoilage of the finished product.

“Simply put, if something is breathing and growing in milk or dairy samples, the new GreenLight and Oculer tests will detect it.”

The global dairy industry is in the middle of an internationally driven boom, with ever-increasing demand from the world’s fastest-growing nations, China and India, as well as the abolition of EU milk quotas in 2015.

Saturday, November 29, 2014

British-Led Scientists Trial 15-minute Ebola Test in Guinea

British scientists announced trials on a 15-minute Ebola test in Guinea as French President Francois Hollande became the first Western leader to visit a country devastated by the epidemic.

The prototype is six times faster than current tests and aims to speed up diagnosis, the London-based global research charity Wellcome Trust and Britain's Department for International Development (DFID) said in a statement.

"A reliable, 15-minute test that can confirm cases of Ebola would be a key tool for effective management of the Ebola outbreak, allowing patients to be identified, isolated and cared for as soon as possible," said Val Snewin of the Wellcome Trust.

She said the test was designed to be suitable for remote field hospitals where electricity and cold storage are often scarce.

The trials, to be led by researchers from Dakar's Pasteur Institute at an Ebola treatment centre in Conakry in the coming weeks, will come as a welcome boon in Guinea which has lost 1,200 people to Ebola.

The biggest Ebola epidemic on record has claimed around 5,700 lives in Guinea, Liberia and Sierra Leone since the beginning of the year, according to the World Health Organization.

President Hollande pledged his support for Guinea after arriving in France's west African former colony on Friday.

He said he was bringing with him a message of solidarity to healthcare workers who "take risks to ensure the highest quality care", and a message of confidence, because "it was very important to tell the world that Guinea is still alive, still fighting".

He also wanted to call for vigilance, he said, because "the battle against Ebola isn't won".

- 'Very important sign -

The visit is the first by a French president since 1999, and comes after France pledged 100 million euros ($125 million) towards the fight against the epidemic in Guinea.

The money will help finance several care centres as well as 200 beds, some of which are reserved for health workers caring for the sick.

France has also pledged to set up two training centres for health workers, one in France and one in Guinea. In addition, French biotechnology companies will set up rapid diagnostic tests in Africa.

Hollande visited healthcare workers at Conakry's Donka hospital, which hosts the city's Doctors Without Borders Ebola treatment unit, alongside his Guinean counterpart Alpha Conde.

Before entering, both men followed the protocol of washing their hands and having their temperatures taken.

The French leader is also due to sign a cooperation agreement with Guinean authorities for the creation of a Pasteur Institute in Conakry by the end of 2016, the global medical research organisation said on Thursday.

"For the people of Guinea, the arrival of President Hollande is a very, very important sign," Conde said.

"If the president of a country as important as France can come to Guinea, that means anyone can come to Guinea."

- Heightened tensions -

The visit comes amid heightened tensions in Guinea over the government's handling of the Ebola crisis and criticism over curbs to free speech.

Conde said on Wednesday the use of force was entirely justified in battling the deadly Ebola outbreak.

"There are still people who think Ebola is fiction," Conde told a news conference in a country where an eight-member Ebola education team was murdered by angry villagers in September.

"We have an agenda which is to finish with Ebola as soon as possible and in Guinea this is possible," he added.

"If people don't want to be treated we will use force because we won't allow the illness to spread despite all our efforts."

Press advocacy organisation Reporters Without Borders has voiced concern about the attacks on press freedom under the pretext of the fight against Ebola.

Meanwhile the Guinean opposition coalition this week denounced the lack of consultation by the government over its strategy for fighting Ebola.

Hollande travelled to the Senegalese capital Dakar later on Friday to take part in a summit of French-speaking leaders that is likely to be dominated by the Ebola crisis as well as the recent unrest in Burkina Faso.

Hollande told a cheering crowd in Conakry that he would "launch a new appeal for international mobilisation. But France must lead by example".

The Federation of Red Cross and Red Crescent Societies urged the international community to refrain from "complacency" despite signs that the epidemic is stabilising in Guinea and Liberia.

"The progress made in the fight against Ebola must be regarded as confirmation that our collective approach is successful and encourage us to stay the course until the epidemic is really under control," said Elhadj As Sy, the head of the organisation.

In a separate development, Mali announced on Friday that it had, for the first time, successfully treated a patient with the virus.

"We announce the first case of treating a person with Ebola virus. This person was treated effectively," said Health minister Ousmane Kone at a press conference.

Wednesday, November 26, 2014

Romer Labs’ RapidChek Listeria NextDay AOAC Certification is Extended for Monitoring Food Samples

Romer Labs announced that its RapidChek® Listeria NextDay™ test system earned Performance-Tested MethodsSM (PTM) certification from the AOAC Research Institute for various ready-to-eat foods with a 27-48 hr. enrichment. The AOAC PTM certification extension for food samples validates RapidChek Listeria NextDay™ as equivalent to the USDA Food Safety Inspection Service’s (FSIS) 48-hour methodology for detecting all 6 Listeria species on food samples, including hot dogs, roast beef, frozen breaded chicken and meatballs and equivalent to the FDA BAM 48-hour methodology for various dairy products.  The RapidChek Listeria NextDay™ system had previously received AOAC PTM certification for monitoring environmental surfaces, including stainless steel, rubber, plastic and concrete under the brand name RapidChek Listeria F.A.S.T. ™.

According to the USDA FSIS, dozens of food product recalls within the last 3 years could have been prevented if the industry routinely followed the “test and hold” practice.  With “test and hold” now in place, many processors are moving from traditional 40-48 hour Listeria methods to faster rapid methods due to storage and spoilage costs.  The NextDay™ system is designed to provide food processors with the benefits of reduced material and processing costs as well as enhanced workflow and reduced time-to-results to meet these needs.

Michael Prinster, CEO at Romer Labs North America, said, “The extension of our AOAC-PTM certification for the RapidChek Listeria NextDay™ system will allow processors and testing labs to obtain next-day results for ready-to-eat food samples using the same cost-effective, accurate test system that has successfully been implemented in many facilities around the world for environmental samples.  RapidChek® Listeria NextDay™ will enable food processors to reach results faster, without comprising accuracy.  We are very pleased with this AOAC certification and believe that our test system will serve to further strengthen Romer’s position in the pathogen testing market.”

Tuesday, November 25, 2014

Thermo Fisher Scientific and Samsung Electronics to Collaborate on Point-of-Care Diagnostic Solutions

To answer the healthcare industry’s demand for better point-of-care (POC) diagnostics, Thermo Fisher Scientific Inc. and Samsung Electronics Co., Ltd. have formed a strategic collaboration. The companies will jointly design, develop and market new POC solutions in key applications, such as the detection of sepsis, drugs of abuse and therapeutic drug monitoring as well as the detection of cardiac problems and women’s health conditions.

“Samsung has developed a compelling and innovative suite of POC platforms,” said Marc Tremblay, Ph.D., president of Thermo Fisher’s clinical diagnostics business. “We look forward to working with Samsung to add some of our leading biomarkers and assays to their platforms to create a truly differentiated testing menu.”

“We are very excited to leverage Thermo Fisher Scientific’s strong commercial sales and service channels, as well as the potential to offer a broader range of tests to our customers and their patients,” said Soo-In Cho, president and head of the health & medical equipment business at Samsung. “This strategic collaboration combines the strengths of two industry leaders to accelerate POC innovation and more rapidly bring solutions to market.”

According to the National Institutes of Health (NIH), POC testing enables patient diagnoses in a physician’s office; an ambulance; anywhere in the field, including a home; or in a hospital. This facilitates more rapid diagnosis and treatment. In its “fact sheet,” the NIH writes: “Empowering clinicians to make decisions at the ‘point-of-care’ has the potential to significantly impact health care delivery and to address the challenges of health disparities.” (See

Monday, November 24, 2014

TECHLAB Develops Diagnostic for Tropical Disease

Vacationers might spend time finding the perfect souvenir to remember a trip. One thing they don’t want to bring home, however, is Montezuma’s Revenge.

According to the Centers for Disease Control, diarrhea is the most common travel-related illness, afflicting 30 to 70 percent of travelers. Unfortunately, there can be many different causes for diarrhea, with varying degrees of seriousness. Bacteria or viruses can make you feel sick within hours, but usually pass after a few days. Those who contract a parasite may not get sick for a week or two, but symptoms can persist for months. Without proper treatment, this kind of diarrhea is dangerous—even deadly.

TECHLAB®,Inc. (“TECHLAB”), a Blacksburg-based medical diagnostics firm, has developed a fast, easy-to-use diagnostic kit to identify Entamoeba histolytica, a protozoan parasite that can be acquired in many tropical and sub-tropical locales.

“Entamoeba histolytica infects an estimated 50 million people worldwide, causes not just diarrhea, but also colitis and liver abscesses, and is responsible for an estimated 100,000 deaths each year,” Tracy WilkinsCharlie Pennington, TECHLAB president, said.

The TECHLAB® E. HISTOLYTICA QUIK CHEK™ test is non-invasive and takes only 30 minutes to get results. The E. HISTOLYTICA QUIK CHEK™ test recently received the CE Mark for sale outside of the United States; review by the FDA for domestic distribution is pending. The test is quick and easy to read, requires no extra instrumentation, and provides sensitivity comparable to more labor-intensive techniques.

The E. histolytica parasite is difficult to diagnose because it resembles Entamoeba dispar, which does not cause disease. The TECHLAB® E. HISTOLYTICA QUIK CHEK™ test (“E. HYSTOLYTICA QUIK CHEK”) is the first rapid antigen test available that differentiates between E. histolytica and E. dispar. Other diagnostic methods that differentiate between the two organisms take hours to get results.

E. histolytica can be treated easily with oral antibiotics, while its look-alike, E. dispar, does not require treatment. Overprescribing antibiotics is dangerous for patients due to potential side effects and growing concerns about antibiotic resistance.

“Our newest diagnostic kit is a novel tool in the worldwide fight against diarrheal diseases,” Pennington said. While parasitic diarrhea is an uncomfortable and inconvenient affliction for adult travelers, it can be fatal for children who live in the developing world. “The diseases that cause diarrhea are preventable, but a few bouts of moderate diarrhea can cause cognitive impairment, growth stunting, and even death for children living in unsanitary conditions,” Pennington said. “We hope E. HISTOLYTICA QUIK CHEK can help travelers, but more importantly, we hope it can help improve global health.”

“E. HISTOLYTICA QUIK CHEK is an advancement for worldwide healthcare, but it is also an achievement for our local community. The test was developed and is manufactured in the New River Valley. The project has brought jobs and infrastructure improvements to the region,” David Lyerly, TECHLAB vice president of research and development, said.

Joel Herbein, TECHLAB senior research scientist and principal investigator for the E. HISTOLYTICA QUIK CHEK project, describes the importance of industrial-academic partnerships in producing medical diagnostics: “The TECHLAB launch of the E. HISTOLYTICA QUIK CHEK is a celebration of regional and international cooperation.” TECHLAB collaborated with William A. Petri, Jr.’s expert E. histolytica research team at the University of Virginia and Rashidul Haque’s clinical study site in Dhaka, Bangladesh, an area where E. histolytica is endemic. “Based on the combined strength of TECHLAB as a profitable manufacturer and a world renowned research group, we were able to secure $4.5M in biodefense initiative small business grants from the National Institutes of Health to help support the project,” Herbein said.

Founded in 1989, TECHLAB® Inc. is a global leader in developing and manufacturing premium diagnostics for diarrheal diseases. TECHLAB research teams focus on enteric diseases and the microbiology of the intestinal tract. TECHLAB offers diagnostic kits for colitis, parasitology, intestinal inflammation, and Shiga toxins. Headquartered in Blacksburg, Virginia, TECHLAB is dedicated to excellence in its diagnostics and research. TECHLAB diagnostic kits are available through its distributor and partner, Alere™, a leading global provider of diagnostic products and health information solutions. Together, TECHLAB and Alere provide high quality, rapid diagnostics for your enteric needs.

Chembio Signs Agreement With CDC Contractor to Develop a Multiplex Point-of-Care Test for Influenza Immunity

Chembio Diagnostics, Inc., a leader in point-of-care (POC) diagnostic tests for infectious diseases, today announced that it has entered into a follow-on, milestone-based development agreement with a private contracting organization acting on behalf of the United States Centers for Disease Control and Prevention (CDC), for a multiplex POC influenza immunity test utilizing Chembio's patented Dual Path Platform (DPP®) technology.

As a result of pandemic planning activities, the United States Department of Health and Human Services (HHS) and the CDC identified POC and high-throughput testing as a gap in influenza diagnostics. Rapid responses in the field — such as the vaccination, prophylactic treatment or isolation of patients — require POC diagnostic tests for influenza infection and immunity. Ideally, these tests should be fast, portable, self-contained and non-technical.

John Sperzel, Chembio's Chief Executive Officer, commented, "We are pleased to continue with this development program, which builds upon our experience and expertise developing multiplex POC assays using our proprietary DPP® technology, and we are pleased that the CDC and its contracting partner continue to see value in our DPP® technology. Our innovative and versatile DPP® technology is ideally suited to rapidly test for multiple influenza immunities, where rapid access to this information can guide treatment decisions and help avert widespread outbreaks."

The prior development work for a DPP® Influenza Immunity Assay was completed by Chembio between 2010 and 2013, pursuant to previous contracts with the same organization. The current project is being funded by the same organization and contemplates a timeline of three months to optimize the multiplex POC DPP® Influenza Immunity Assay to determine a person's influenza immunity status in the field or in an outpatient setting, while incorporating certain additional subunits of influenza virus proteins.

Thursday, November 20, 2014

i-calQ Receives U.S. Patent for Smartphone-Based Method of Rapid Diagnostic Testing

i-calQ LLC today announced that the United States Patent and Trademark Office has granted the company a patent for a method to test “biological samples and body fluids” using an inexpensive smartphone attachment to “quantify, interpret, and record point of care diagnostic testing, creating, in essence, a low cost, portable, easy to use system that can replace the traditional medical laboratory.”

i-calQ’s patented, low-cost technology consists of disposable test strips, a universal reader attachment that is compatible with all makes and models of smartphones, and a decision support app that reads quantitative results from disposable test strips, provides rules-based expert algorithm support to interpret the results and recommends additional testing, treatment, and follow-up. The app automatically prints the results and transmits the results using either mobile data network or wireless internet connection to a cloud database or electronic medical record.

Joel Ehrenkranz M.D., i-calQ’s chief medical officer, begin innovating in the field of smartphone-based point of care diagnostics while working in an Ebola epidemic in Uganda in 2007. He recognized how the inability to promptly diagnose Ebola was costing lives and allowing the epidemic to spread.

Seeing the potential for convergence of mobile phone technology and modern medicine to help control the 2007 Ebola outbreak, Dr. Ehrenkranz foresaw how smartphones could become an essential platform for the next generation point-of-care diagnostics.

“In the most remote part of Uganda where very little worked, mobile phones did,” Dr. Ehrenkranz said. “It suddenly became obvious that the essential features of mobile phones could be used as portable clinical laboratories to test and interpret results and transmit this information to a centralized public health database. In 2007 it was an just an idea, but in 2014, it is reality.”

Promoting Cost-Effective Health Care

i-calQ’s technology can increase the penetration of public health surveillance, bringing specialist expertise to anywhere a smartphone goes, be it be a remote medical clinic or the privacy of a patient’s home.

i-calQ’s technology also has positive implications for the health and fitness of Americans who are concerned about changes in medical services and costs.

In addition to professional medical applications, personal biometric monitoring using i-calQ’s technology can be used to monitor nutrition, fitness, stress, and fertility. i-calQ’s technology can be used to identify whether a particular vitamin or supplement might be beneficial and the correct dose to take.

“If used wisely, these tests could reduce the number of doctor visits, lower insurance and medical costs, help individuals improve their health and fitness, and give consumers some control over their healthcare options,” explains Pamela Turbeville, CEO of i-calQ.

Monday, November 17, 2014

FDA OKs Army's Diagnostic Tool for Skin Disease

Army scientists at Fort Detrick are hailing the Food and Drug Administration's approval of a tool they helped develop for rapidly diagnosing a disfiguring skin disease caused by sand fly bites in the Middle East.

The U.S. Army Medical Research and Materiel Command said Friday that the hand-held dipstick can produce results within 30 minutes. The previous method depended on laboratory tests of skin-lesion samples that often had to be shipped to the United States.

Lt. Col. Jeanne Norwood says rapid diagnosis means quicker treatment for the disease, called cutaneous leishmaniasis.

Leishmaniasis is a parasitic disease that is found in parts of the tropics, subtropics, and southern Europe. It is classified as a Neglected Tropical Disease (NTD). Leishmaniasis is caused by infection with Leishmania parasites, which are spread by the bite of phlebotomine sand flies. There are several different forms of leishmaniasis in people. The most common forms are cutaneous leishmaniasis, which causes skin sores, and visceral leishmaniasis, which affects several internal organs (usually spleen, liver, and bone marrow).

The Army says the disease affects millions worldwide, including U.S. service members. The World Health Organization reported a major outbreak in Afghanistan in 2010.

The device is made by Seattle-based InBios International Inc.

Friday, November 14, 2014

Test Developed for Rapid Diagnosis of Bloodstream Infections

A  new bloodstream infection test created by Univ. of California, Irvine (UCI) researchers can speed up diagnosis times with unprecedented accuracy, allowing physicians to treat patients with potentially deadly ailments more promptly and effectively.

The UCI team, led by Weian Zhao, assistant professor of pharmaceutical sciences, developed a new technology called Integrated Comprehensive Droplet Digital Detection. In as little as 90 mins, IC 3D can detect bacteria in milliliters of blood with single-cell sensitivity; no cell culture is needed.

The work appears online in Nature Communications.

“We are extremely excited about this technology because it addresses a long-standing unmet medical need in the field,” Zhao said. “As a platform technology, it may have many applications in detecting extremely low-abundance biomarkers in other areas, such as cancers, HIV and, most notably, Ebola.”

Bloodstream infections are a major cause of illness and death. In particular, infections associated with antimicrobial-resistant pathogens are a growing health problem in the U.S. and worldwide. According to the Centers for Disease Control & Prevention, more than 2 million people a year globally get antibiotic-resistant blood infections, with about 23,000 deaths. The extremely high mortality rate for blood infections is due, in part, to the inability to rapidly diagnose and treat patients in the early stages.

Recent molecular diagnosis methods, including polymerase chain reaction, can reduce the assay time to hours but are often not sensitive enough to detect bacteria that occur at low concentrations in blood, as is common in patients with blood infections.

The IC 3D technology differs from other diagnostic techniques in that it converts blood samples directly into billions of very small droplets. Fluorescent DNA sensor solution infused into the droplets detects those with bacterial markers, lighting them up with an intense fluorescent signal. Zhao said that separating the samples into so many small drops minimizes the interference of other components in blood, making it possible to directly detect target bacteria without the purification typically required in conventional assays.

To identify bacteria-containing droplets among billions of others in a timely fashion, the team incorporated a 3-D particle counter developed by UCI biomedical engineer Enrico Gratton and his colleagues that tags fluorescent particles within several minutes.

“The IC 3D instrument is designed to read a large volume in each measurement, to speed up diagnosis,” Gratton said. “Importantly, using this technique, we can detect a positive hit with very high confidence.”

A UCI spinoff, Velox Biosystems, is now further developing the IC 3D technology.

Cepheid Receives Grant to Develop Ebola Diagnostic Test

Molecular diagnostics company Cepheid said it received a grant of up to $3.3 million, co-financed by the Paul G. Allen Family Foundation and the Bill & Melinda Gates Foundation, to develop a diagnostic test for the deadly Ebola virus.

The Xpert Ebola test, which is expected to use saliva or a drop of blood to identify the virus, is likely to be offered on an emergency use only basis, Cepheid said on Thursday.

Cepheid and the Gates Foundation are also evaluating deploying the company's RemoteXpert cloud-based monitoring software to help track the spread of the disease.

Cepheid joins a list of diagnostic makers looking to develop tests to accurately and quickly detect Ebola, which has killed more than 5,000 people so far.

The U.S. Food and Drug Administration last month granted emergency authorization to two new Ebola diagnostic tests made by BioFire, a subsidiary of medical diagnostics maker BioMerieux .

Salt Lake City-based BioFire's tests can detect Ebola in blood or urine samples in one hour, a significant improvement on the 24 to 48 hour time frame that currently available tests take to pinpoint the disease.

Chembio Diagnostics Inc said last month that it had begun developing point-of-care diagnostic tests for Ebola and febrile illness in partnership with privately held Integrated BioTherapeutics Inc.

Monday, November 10, 2014

PositiveID Corporation Signs Agreement With U.S. Special Operations Command

PositiveID Corporation, a developer of biological detection and diagnostics solutions, announced today that it has signed a U.S. Special Operations Command ("USSOCOM") Cooperative Research and Development Agreement ("Agreement") with Special Operations Research, Development, & Acquisition Center, Science & Technology Directorate ("USSOCOM SORDAC-ST"), to further develop the Company's real-time PCR (polymerase chain reaction) pathogen detection system, Firefly Dx, for use across the USSOCOM mission space.

PositiveID's Firefly Dx is a point-of-need, handheld system designed to deliver molecular diagnostic results using real-time PCR chemistry. Firefly Dx is being developed to meet the growing need in military and healthcare markets for more rapid and accurate point-of-need diagnostics that will enable hospitals, physicians, deployed military personnel, and others to save lives. Firefly Dx is designed to derive results from a sample in less than 20 minutes, at the point of need, compared to two to four hours for a laboratory-based device, which could enable accurate diagnostics leading to more rapid and effective treatment at the point of care than what is currently available or non-existent with existing systems.

The objective of this Agreement is to provide a foundation for cooperative work between USSOCOM SORDAC-ST and PositiveID to continue the development of Firefly Dx for Special Operations Force ("SOF") applications, and to provide enhanced operational capability to USSOCOM assets. PositiveID will receive requirements, priorities, feedback, and human factors/human systems integration support to facilitate its ability to support SOF technology needs.

William J. Caragol, Chairman and CEO of PositiveID, said, "We are very proud to work in partnership with the Department of Defense and USSOCOM to help fill their need for novel technologies and systems that can be used to safeguard those who protect our country. We intend to utilize their expert guidance as we continue to develop the prototype of Firefly Dx."

FIND and QuantuMDx Partner to Develop Rapid Genome-based Diagnostics for Tuberculosis

FIND, a Geneva-based non-profit organization, is joining forces with UK diagnostics developer QuantuMDx Group to develop a combined solution for the rapid detection of tuberculosis and determination of drug resistance.

The time for full drug resistance profiling will be reduced from a week to less than half an hour based on the molecular detection of an extensive set of genetic markers by the simple handheld Q-POCTM device developed by QuantuMDx.

The uniqueness of the nanowire technology developed by QuantuMDx provides the potential to interrogate the bacterial genome with unprecedented precision, as it allows not only targeted detection of specific markers, but in addition (in a future evolution of the present system) genetic sequencing on the same technology platform.

Under the partnership, FIND is supporting the development of an appropriate and integrated sample handling compartment, while QuantuMDx continues its platform development.

Catharina Boehme, FIND’s CEO noted that "after an extensive screening of different Point-of-Care platform solutions amenable to the decentralized testing for tuberculosis, we concluded that QuantuMDx’s Q-POCTM system provides a unique set of capabilities which allows for the seamless integration of future genetic discoveries and hence will assure a long-term sustainability of the molecular testing approach for tuberculosis."

Elaine Warburton, CEO of QuantuMDx said, “Our strategic partnership with FIND is of immense importance to QuantuMDx. It not only affords us a wealth of experience and expertise in developing and commercializing a much-needed diagnostic device for developing countries, but also provides independent validation of our strongly held belief that the provision of low cost, truly point of care molecular analysis for speciation and drug susceptibility status is a practical and effective tool in helping support the early identification and eventual eradication of MDR-TB and other infectious disease humanitarian health challenges.”

Jonathan O’Halloran, QuantuMDx’s CSO and Q-POCTM inventor added, "Excitingly, our partnership with FIND will support us in navigating the complexities of commercializing a diagnostic device. Furthermore, with networked Q-POCsTM deployed in the field throughout the world we will have an early warning platform to monitor novel pathogens and emerging hotspots of drug resistance in real-time; a concept we like to call the Internet of Life."

Wednesday, November 05, 2014

MBio Diagnostics Awarded Contract for Diagnostic Development With the U.S. Army

MBio Diagnostics, Inc. announced today it was awarded a three-year development contract with the U.S. Army's Walter Reed Army Institute of Research (WRAIR) for the "Development of a Ruggedized Portable Cartridge Reader for Malaria Diagnosis."

Under this contract, MBio Diagnostics will develop a low cost, multi-analyte "point-of-care" (POC) diagnostic device for malaria with enhanced sensitivity, quantitation capabilities, and automated data capture and transmission, using the company's planar waveguide LightDeck® technology. The work will be carried out collaboratively with Dr. John Waitumbi of the United States Army Medical Research Unit-Kenya (USAMRU-K), which is a "Special Foreign Activity" of the WRAIR headquartered in Nairobi, Kenya. The USAMRU-K unit develops and tests improved means for predicting, detecting, preventing, and treating infectious disease threats important to the U.S. Military as well as conducts surveillance, training, research and response activities related to emerging infectious diseases threats.

Commenting on the contract, Chris Myatt, CEO of MBio Diagnostics, said, "We are thrilled to be working with Dr. Waitumbi and his team at Walter Reed's USAMRU-K unit to develop a key diagnostic for use in regions where malaria is endemic. This fits naturally with our infectious disease program, where we focus on diagnostics for HIV, influenza, and hemorrhagic fevers."

"We are looking for a high-quality diagnostic device that would strengthen monitoring and early care of deployed US Service Members and civilians in areas where malaria is endemic," said Colonel Rodney Coldren, Director of the Department of Emerging Infectious Diseases at USAMRU-K. "This contract begins the process of analysis and development."

It is estimated by the World Health Organization that malaria causes more than 600,000 deaths annually, with 90 percent of those occurring in Africa. Development of medical products for infectious diseases requires access to study populations in field sites where the disease agents are endemic as well as access to clinical trials centers capable of conducting high quality and regulated vaccine and therapeutic trials. Specifically, malaria, HIV/AIDS, enteric pathogens, influenza, hemorrhagic fever viruses, and arthropod-borne diseases are among the most important of the militarily-relevant infectious agents.

To date, malaria rapid diagnostic tests (RDTs) have significant limitations. MBio's planar waveguide technology has a needed and unique ability to combine sensitivity, quantitative analysis, batch processing, automated data capture and transmission, as well as ability to configure for a panel of febrile illnesses.

Tuesday, November 04, 2014

WholeHEALTH Products Announces Completion of its Global Distribution Rights for the Real Time PCR Rapid Ebola Test

WholeHEALTH Products will market its PCR Rapid Ebola Test directly to Africa and South American countries, while WholeHEALTH applies for FDA Emergency Use Approval (EUA) for the US market shortly.

The WholeHEALTH Products PCR Rapid Diagnostic Ebola Whole Blood Test can be done in 3 hours—a vast improvement over waiting days with the present testing.

WholeHEALTH Products' experienced CSO worked with China on the SARS virus, developed a Rapid Diagnostic Test for the H1N1 (Bird Flu), and is heading up the completion of the Rapid Real Time PCR Diagnostic Test for Ebola.

Some fever screening will begin, but the need for a rapid diagnostic test is paramount for airports, once a person has been detected to have a fever.  The fever is not the issue; the airports need to find out right away if this person has Ebola so further testing, quarantine and emergency care issues can be addressed.

WholeHEALTH Products' soon-to-be announced Rapid 15 Minute Lateral Flow Ebola Diagnostic Test will do just that; it will determine with 99% accuracy if the person has Ebola.  Once WholeHEALTH Products completes its Phase 3 in-house study, it will file for the EUA (Emergency Use Approval) for this test as well.

As of 10 October 2014, Africa has reported 8,376 suspected cases resulting in the deaths of 4,024.  Although the Ebola death rate is alarming, the possibility of the virus spreading is ultra critical.  There are several other viruses that kill hundreds of thousands or millions of people throughout the world, such as Dengue Fever, Malaria, HIV, and TB, but the spread of these diseases is not as easy as the spread of the Ebola virus.

Accelerate Diagnostics Announces Research Collaboration With CDC for Early Detection of Antibiotic-Resistant Biothreat Agents

Accelerate Diagnostics, Inc., an in vitro diagnostics company dedicated to providing solutions for the global challenge of drug resistant organisms, today announced that it has entered into a research collaboration with the Rapid Antimicrobial Susceptibility Testing Laboratory at the U.S. Centers for Disease Control and Prevention (CDC) to develop tests for the rapid analysis of antibiotic-resistant biothreat agents based on Accelerate's high-speed identification and antibiotic susceptibility testing platform.

Bacterial, biothreat agents and diseases such as anthrax, tularemia and plague pose significant national security and public health risks. While infections with these pathogens are rare in the United States, they can be disseminated or transmitted from person-to-person and result in high mortality rates. They therefore require special public health preparedness and surveillance so that any potential biothreat activity or disease outbreaks can be rapidly identified and contained. Early detection, isolation and treatment with effective antibiotics are critical to cure patients and limit the spread of disease.

Unfortunately, conventional testing methods available in hospital and public health labs can take several days to produce results. These methods are therefore unable to provide critical, time sensitive information to the healthcare community, denying caregivers the opportunity to manage infection and prevent outbreaks at the earliest stage.

Accelerate Diagnostics is developing a fully integrated, easy-to-use platform that provides high-speed identification and antibiotic susceptibility testing of pathogens, working directly from patient samples. The platform enables laboratories to provide critical microbiology results in hours instead of days.

As part of the collaboration with the CDC laboratory, Accelerate Diagnostics will use its expertise to develop assays for rapid identification of key bacterial biothreat agents, their virulence markers, and their antibiotic susceptibility and resistance profiles. The CDC will provide scientific expertise on the microbiology and molecular biology of biothreat agents, and will evaluate and optimize the performance of the platform, using its collection of biothreat agents. As part of the agreement, the CDC has purchased the Accelerate ID/AST platform for use in their laboratory.

"Early detection of highly infectious bacteria, including biothreat agents, and determination of their susceptibility to specific antibiotics are essential for patient management and protection of public health," said Larry Mehren, CEO of Accelerate Diagnostics. "We are honored and highly motivated to be working with the CDC on this critical public health and national security project."