Friday, January 23, 2015

U.S. Army Advances Bio-Threat Detector

The U.S. Army's second-generation Tactical Biological Detector, or TACBIO, will provide Soldiers with a lightweight, low-power, highly effective biological detector, officials said.

The Army introduced the original TACBIO in 2010, and it was named to the Maneuver Support Center of Excellence Top 10 List of Excellent Technologies.

A team of scientists and engineers from the U.S. Army Edgewood Chemical Biological Center, or ECBC, advanced the TACBIO into a more capable and lower cost detector called the TACBIO Gen II.

The new design captures performance and cost advantages associated with plastic parts.

The TACBIO Gen II is designed to rapidly detect the presence of an aerosolized biological threat and to provide an early warning to minimize exposure and casualties to the warfighter. The device exploits the scientific principle that biological aerosols will fluoresce and scatter light when exposed to ultraviolet light.

These signals can be used to detect the existence of a threat by using a light emitting diode developed under the Defense Advanced Research Projects Agency that replaces the larger and more costly UV lasers.

The detector is made of plastic, weighs three pounds three ounces and has a simple design that makes it easy to manufacture. ECBC designed, built and tested the system.

In quantities of more than 10,000 detectors, the TACBIO Gen II costs only $2,000, an $8,000 decrease from the first-generation TACBIO.

"With the cost per detector cheaper in bulk, it helps the Army and other users to perform raid detection where they can set out multiple detectors in a space," said Aime Goad, acting chief of ECBC's Sensors, Signatures and Aerosol Technologies branch. "More detectors mean less false positives with biological detection, ensuring that users can make accurate and fast decisions based on the detector results."

The TACBIO Gen II is small and light enough to be put out as a network and mounted to vehicles, robots, unmanned aerial vehicles and more to detect the presence of a biological threat.

Now that the detector is in use, Goad imagines several uses for the technology outside of the Army to the other services and civilian use.

The technology in the TACBIO Gen II could be changed to become an environmental detector to monitor air quality in hospitals, the Federal Aviation Administration could use it to monitor air quality during flights, or it could even be used in households to monitor for things like fungus or mold.

As a part of ECBC's Innovative Proposal Program, researchers are exploring the capabilities of how TACBIO Gen II is used to detect chemical agent.

ECBC transitioned the TACBIO Gen II to private industry through a patent licensing agreement and a cooperative research and development agreement for large-scale distribution and fielding. ECBC won the 2012 Federal Laboratory Consortium Award for Outstanding Technology Transfer.

The TACBIO and TACBIO Gen II have also earned two U.S. patents.

Thursday, January 22, 2015

Crystal Diagnostics Awarded AOAC-PTM Accreditation for the Rapid Detection of “Big 6” E.coli Food Pathogens

Crystal Diagnostics (CDx) Xpress System, a rapid and sensitive detection platform, announced today that it has received AOAC-PTM Certifications for the six non-O157 Shiga toxin-producing E. coli (serogroups O26, O45, O1O3, O111, O121, and O145; collectively referred to as STEC or the “Big-6”) as well as Escherichia coli (E. coli) O157, at 1 colony forming unit (cfu) per 325 g of raw ground beef and raw beef trim, or 200 g of raw spinach.

The CDx Xpress System combines proprietary liquid crystal technology with antibody-coated paramagnetic microspheres to selectively capture and detect STEC from food matrixes, faster than other commercial systems.

The USDA requires all federally inspected beef processors to test for these potentially deadly pathogens and Crystal Diagnostics becomes one of only seven companies to gain AOAC accreditation.

Dr. Gary Acuff, Director of the Texas A&M Center for Food Safety, stated “As regulatory agencies continue to tighten food safety requirements, it is likely that more and more pathogen testing will be utilized to verify process control. CDx has developed a unique detection system which is highly accurate, reliable, and takes about half the time required by the FDA reference method. This STEC test will be a welcomed addition to many food safety programs.”

According to CDx President and CEO, Jim Bruce, “Our goal for the past eight years has been to develop a novel technology which is much faster and more accurate than traditional rapid detection systems. These recent AOAC accreditations of our system confirm that we have done just that.”
CDx is currently developing additional protocols and kits for the detection of Listeria, Salmonella spp. and strain-specific Salmonella. The Company expects an AOAC certified Salmonella test by midyear, with Listeria shortly thereafter.

Wednesday, January 21, 2015

Hygiena Introduces an Easy-to-Use Rapid Salmonella Environmental Monitoring Test

Hygiena has introduced the newest addition to its line of rapid microorganism tests; InSite Salmonella is a rapid and convenient colorimetric Salmonella species test for environmental surfaces.

InSite Salmonella is a self-contained, ready-to-use swab test which contains a specialized liquid medium which changes color when Salmonella species are present in the sample. A color change from purple to bright yellow indicates presence, with positive results in as early as 24 hours from sample collection. The all-in-one test device eliminates the need for sample preparation materials, saving material and labor costs. Other environmental Salmonella species test kits require several complicated steps including measurement and mixing of media, sample enrichment, and transfer of enriched sample to the test device. InSite Salmonella’s convenient design eliminates the need for any special preparation, measurement, or enrichment outside the test device, simplifying the assay so any level user can successfully run the test, virtually eliminating the possibility of operator error.

Environmental pathogen screening, such as with InSite Salmonella, is a critical element of a comprehensive environmental monitoring program for certain food manufacturers. Not only does environmental monitoring verify sanitation is effective, it is also part of a well-designed preventive control verification program. The US Food and Drug Administration’s proposed rule for preventive controls in the Food Safety Modernization Act suggests emphasis on environmental pathogen monitoring for food processors with significant contamination risk. Accordingly, InSite Salmonella meets the needs of food processors for a rapid, convenient, and affordable environmental pathogen screening test kit.

InSite Salmonella joins Hygiena’s line of rapid microorganism tests, including those for Total Viable Count, Listeria species, Enterobacteriaceae, Coliform, and E. coli. Other products from Hygiena include the world’s best-selling ATP monitoring systems and convenient allergen prevention test kits.

European Inventor Armed with Lab-on-a-Chip Fights Infectious Disease

Some argue antimicrobial resistance (AMR), the ability of microbes to develop resistance to antimicrobial drugs, is a growing threat. Others say superbugs are already here, citing the increase in strains of antibiotic-resistant tuberculosis worldwide and the spread of staph infections.

There's little argument about this fact, however: if we are not in a post-antibiotic era now, we will be soon. Such an era would see patients dying from common infections caused by bacteria, parasites, virus and fungi, and from minor injuries.

In a study commissioned by British Prime Minister David Cameron, it was found that drug-resistant infections will reach global costs of $100 trillion and will add 10 million deaths a year, by 2050.

In the overall war against antibiotic resistance, the battle against hospital-acquired infections plays a major role. While infections can be caught anywhere, many of the antibiotic-resistant infections occur in hospitals and other medical facilities. Resistance is inevitable, but overly-broad prescriptions, inaccurate prescriptions and misuse of antibiotics exacerbate the problem. According to the Infectious Disease Society, up to 50 percent of antibiotic use is unnecessary or improperly used.

These infections that attack patients, making them sicker than they were when they came in with a previous illness, derail the name and purpose of health care. They cost billions of dollars. They cost thousands of lives.

While a recent report from the Centers for Disease Control and Prevention (CDC) in the U.S. reported a noticeable reduction in some cases of hospital-acquired infections, other infectious diseases, such as influenza and malaria, are becoming increasingly resistant to antibiotics and remain at large.

To be able to slow the development of drug-resistance, medical professionals must treat infections with accurate and specific antimicrobial drugs. The problem here, however, lies in the unknown. If the specific source of the problem (i.e. the bug causing the infection) isn't known, physicians often prescribe an overly-broad antibiotic, hoping it will eliminate the problem. Often it doesn't - it just puts the patient at risk and adds to the factors spurring on drug resistance.

To inspire companies to develop technology that would help physicians isolate the cause of infections and prescribe the right drugs in the right doses, Nesta and Innovate UK launched the Longitude Prize 2014. With a £10 million prize fund, the contest is an effort to combat the growing problem with a "cost-effective, accurate, rapid and easy-to-use test for bacterial infections that will allow health professionals worldwide to administer the right antibiotics at the right time."

One contender for the prize is Professor Chris Toumazou, winner of the European Inventor Award in 2014, and his company, DNA Electronics (DNAe). His semiconductor DNA sequencing technology, Genalysis, is a microchip that turns chemically encoded DNA into digital information that can help treat hospital-acquired infections - in particular, sepsis.

An increasingly problematic infection, sepsis, which results in inflammatory responses in the body triggered by chemicals in the bloodstream, can lead to severe organ failure and death. In the U.K. alone, sepsis kills over 37,000 people a year. The key to preventing this is early treatment of the infection with antibiotics and fluids.  

To ensure physicians use the correct drugs to treat these infections, Toumazou developed his semiconductor DNA sequencing technology around a small device the size of a USB stick.

"It was a eureka moment when I just took a microchip, and instead of putting electricity on [it], I put DNA, and the microchip turned on. It was sort of 'wow, I've got a really neat way now of sequencing DNA,' " Toumazou said excitedly.

The microchip technology is more than just neat, it's brilliant. On the surface of the microchip, when the electrical gate is peeled off, a chemically sensitive layer of silicon nitride is revealed. Immobilizing the DNA onto the surface and putting down the nucleotides, the building blocks of nucleic acids such as DNA, releases pyrophosphate, which brings on a pH change. The change essentially "turns on" the semiconductor, similar to how a pH probe works, except with the chip the nucleotide bases must be matching. While the chip is detecting the mutations, the DNA is also getting amplified.

"If the DNA matches, you got the mutation and it turns on the semiconductor, and if it doesn't match, it doesn't work," Toumazou explained.

So how can this device, smaller than a thumb, help fight sepsis infections in hospitals? It goes back to isolating the right bug, or the correct source of the problem, and eliminating the bug with a specific antibiotic rather than a broad one. But in the case of sepsis, isolating the bug needs to happen quickly.

"It's really all about speed," he says. The faster you can isolate the DNA of the bug, the sooner the proper antibiotic can be prescribed. It takes too long for hospitals to send cultures to the lab to identify the bug. While the culture is being developed, infections can turn deadly. The semiconductor microchip isolates the DNA of the bug in under an hour, giving physicians time to prescribe the correct, tailored antibiotic, often before pre-sepsis turns into full-blown sepsis.

The quicker the bug is isolated for any infection, the higher the chance the correct antibiotic will be prescribed. If broad or incorrect antibiotics are prescribed less often, medical professionals will contribute less to the development of antibiotic-resistant strains ringing in the post-antibiotic era.

"It's all down to making sure that you've got the right tailored medicine for that individual," Toumazou says. That's why he focuses on personalizing medicine based on quickly identifying mutations. He was inspired to develop tools for personal genetics after his son, Marcus, was found to have a genetic predisposition to renal disease. Marcus lost his kidneys at a young age. Toumazou believes that knowing about the predisposition earlier would have helped him manage Marcus's lifestyle and make it more comfortable. Marcus later received a kidney transplant, but went through a challenging period of time beforehand living with monitors and a dialysis machine.

If his son's medical difficulties were the motivators for Toumazou's interest in personalized genetics, Toumazou's experience as a professor at Imperial College London was the inspiration for his semiconductor microchip. Much of the idea for a device that combines speed and cost to fight infectious disease came from his encounters with clinicians at the school's hospital. These clinicians faced the nightmare of hospital-acquired infections everyday and he heard about the problem firsthand. He realized personalization was not only helpful, it was essential.

Genalyte Developing Differential Ebola Test for Maverick Chip-based System

During the Ebola crisis that swept through West Africa in 2014 and is ongoing in certain countries, efforts at dealing with the virus that has killed more than 8,000 people on the continent have been hindered by an inability to differentially diagnose Ebola from other similar ailments.

Now, though, Genalyte has developed a test that it says can tell whether a patient has Ebola or one of a number of other similar diseases, including hemorrhagic fevers, with a single drop of whole blood in about 10 minutes.

The panel currently has been developed to detect and differentiate the Zaire Ebola strain from malaria, Dengue fever, Marburg, and West Nile virus, while other disease indications, including Lassa fever, yellow fever, and HIV are also being developed for inclusion on the panel, which will target a total of 16 diseases, GenalyteP resident, CEO and Founder Cary Gunn told GenomeWeb last week on the sidelines of the 33rd Annual JP Morgan Healthcare Conference in San Francisco.

Called the Maverick Detection System, Genalyte's technology is a silicon chip-based method, in which blood is flowed over sensors embedded in the chip. The Maverick platform interrogates and reads the chip to detect proteins binding to the sensor in real time. Genalyte software then uses real-time binding measurements to quantify the concentration of proteins and generates a test result. Because there is no need for labeling or washing, the need for a central laboratory to run the test is eliminated, Gunn said.

While other methods, including those based on PCR, are more effective for the early detection of Ebola, Gunn acknowledged, he said that in some instances, such alternative technologies, which are more expensive and time-consuming, may not be the best option.

"What we're going for is broad spectrum, multiplexing," he said, adding that his firm's test targets the "differential diagnosis for someone who presents with the acute disease," rather than the screening of asymptomatic populations.

According to Gunn, such a technology would have had use during the recent outbreak in West Africa. In a report released last week, the World Health Organization noted that one underlying factor that prevented a more efficient response to the outbreak was confusion with other illnesses that presented similar symptoms and diagnoses to Ebola.

"All previous Ebola outbreaks occurred in countries with a number of long-tenured infectious diseases that mimic the early symptoms of Ebola and help keep the disease hidden," the report said. "The initial symptoms of malaria, for example, are indistinguishable from those of Ebola. … As a further complicating factor, the incidence of Lassa fever — which, like Ebola, is a viral hemorrhagic fever — is uniquely high in this West African region, with Sierra Leone recording the world's highest incidence of cases."

Genalyte's test, which costs $10, is robust, Gunn said, and does not need to be reflexed to another method for confirmation, adding it is a near-patient test and operates off a workflow that can be CLIA-waived. While access to electricity is needed to run the test, a clean room and liquid handling capabilities are not required, he said.

Genalyte is currently providing the test to African government agencies for evaluation. Gunn declined to disclose the cost of the Maverick instrument to run the test but said that Genalyte is negotiating pricing for West Africa. The system, he noted, would fit into a lab's broad testing abilities as it can also be used for testing aimed at infectious disease, allergies, and autoimmune disease.

Genalyte joins a growing number of companies and organizations that have hastened the development of an Ebola test as the Ebola crisis spilled over from Africa and fears were raised when a few cases reached the US. Scientists from the University of Arizona, for instance, are developing a handheld PCR-based device for the rapid detection of the virus. Also, Roche, BioFire Defense, and Altona Diagnostics each received emergency use authorization from the US Food and Drug Administration for their Ebola tests.

Meanwhile, the Massachusetts Life Sciences Center issued a $1 million challenge grant for the development of a rapid, disposable molecular diagnostic test for the Ebola virus.

Genalyte does not intend to seek an EUA for the Ebola test, Gunn said.

Genalyte, which was founded in 2007, has been developing its technology for a number of years, Gunn said, and the company has a number of its Maverick systems placed in government facilities. The purpose of its Ebola test is "to be ready for this the next time [an epidemic] comes around," he said, "and also to provide a test for a large number of other diseases that are a lot more common than Ebola. We would be happy if the Ebola test never showed up positive again."

Beyond Ebola

The Maverick system, he said, can detect up to 128 diseases from a single finger prick of blood "and then it's about how you bring that to market and … the applications, and infectious disease is one of the obvious applications." While infectious disease tests that run on the system are not available in the US, it is on Genalyte's roadmap, Gunn said.

Based in San Diego, the privately held firm spent its first few years developing its silicon chip technology, and its first product was an immunogenicity test launched to the pharmaceutical space. Genalyte can multiplex all isotypes of antibodies against the drug, "so we can see the entire spectrum of antibodies, including IgG4."

IgG4-related systemic diseases are marked by inflammatory cells that cause fibrosis and include autoimmune pancreatitis, Riedel's thyroiditis, and Mikulicz's syndrome. The company's main source of commercial revenues is derived from its pharma business, Gunn said.

As it seeks to move into the diagnostics space, Genalyte is focused on infectious diseases and autoimmune diseases. Gunn said that it also sees vaccine rejection testing, and immunogenicity testing as possible companion diagnostic opportunities down the road.

Scientist Invents Rapid Test Capable of Detecting Viruses

A research scientist of Liberian origin, Dr. Dougbeh Chris Nyan, has invented a diagnostic test that can detect and distinguish seven different viruses at the same time. The viruses include HIV, hepatitis viruses, and another virus called Dengue hemorrhagic fever virus (which has similar symptoms like the Ebola virus) infection.

As lead-inventor, Dr. Nyan developed the test while working at the Laboratory of Emerging Pathogens at the US Food and Drug Administration (FDA) in the United States of America. The test is what scientist called a rapid procedure that can give test-results in less than one hour by using the patient blood samples. According to the US Federal Registry publication of October 15, 2014 entitle “Quantitative Multiplex Methods for Rapid Detection and Identification of Viral Nucleic Acids”, the test has been patented by the US government.

Information available to the FDA and the NIH technology office, the US government may have an interest in filing an international patent application for Dr. Nyan’s inventions. Already, part of the test in diagnosis of Hepatitis B virus was published in May 2014 in a journal, called Clinical Infection Diseases. The test, which also has the capability of detecting Ebola virus and other tropical infections could be useful in countries that are now affected by the present Ebola epidemic. Ability for rapid diagnosis is a problem in many poor countries and places that do not have advanced health care systems.

Thus, this test is a major development that could empower health care workers with a quick means of diagnosing many viral diseases in countries with less resources. Dr. Nyan, who testified on September 17, 2014 to the US Congress on the Ebola crisis in West Africa also works as an unpaid volunteer with the Diaspora Task Force on the Ebola Crisis, with which he serves as Director of its Secretariat.  The Diaspora Task Force has carried out medical relief supplies to the Ebola affected region and is recruiting Diaspora medical personnel to send them to work in the region.

Also, Dr. Nyan is championing the creation of institute for disease control in Liberia and the region as a post-Ebola public health measure. A German trained medical doctor, Dr. Nyan also worked at the National Institutes of Health where he was trained in biomedical research. It can be recalled that Dr. Nyan in 1999 at the NIH developed a non-invasive diagnostic test for Helicobacter pylori infection. In a scientific environment where minorities and people of African descent are disadvantaged, Dr. Nyan hopes that his intellectual property rights will be fully protected and that the product of his invention will serve the poor and needed populations in society.

Tuesday, January 20, 2015

Abaxis, Inc. Announces USDA Approval of VetScan FeLV/FIV Feline Rapid Test

Abaxis, Inc., a medical products company manufacturing point-of-care instruments and consumables for the medical, research, and veterinary markets worldwide and providing reference lab services to the veterinary and research markets in the United States, today announced that the Center for Veterinary Biologicals of the U.S. Department of Agriculture (USDA) has approved its VetScan FeLV-FIV Rapid Test Kit for the detection of FeLV antigen and FIV antibodies from feline blood samples.

Clint Severson, chairman, president and chief executive officer of Abaxis, said, "The USDA approval of the VetScan FeLV-FIV Rapid Test kit is a significant step towards completing the Abaxis rapid test portfolio. Feline Leukemia virus (FeLV) and the feline immunodefiency virus (FIV) are retroviruses found in cats, and are among the most common infectious diseases in this species. FeLV-FIV testing is one of the most common tests performed by veterinarians treating feline patients, and Abaxis is proud to offer another high quality, cost-effective test to the veterinary market."

Dr. Craig Tockman, vice president of sales and marketing for North American Animal Health of Abaxis, added, "Veterinarians now have a choice as to what FeLV-FIV test to use when they screen and test their feline patients for these devastating illnesses. As part of the Abaxis rapid test portfolio offering single tests for vector-born and fecal diseases, veterinarians now have the ability to test for the diseases that are relevant to their practice and geographic location."

Vivione Biosciences Inc. Announces a Strategic Partnership with Sale of the RAPID-B System to AES Water Solutions

Vivione Biosciences Inc. ("Vivione") (VBI), announced today that it has sold the first of multiple RAPID-B systems for oilfield applications to AES Water Solutions, a wholly-owned subsidiary of HII Technologies. AES Water Solutions has deployed the RAPID-B system to its Eagle Ford and Permian Basins oil and gas operations to assess bacteria in pond, frac, and flow back water. Water pumped underground during the hydraulic fracturing process is often laden with bacteria, causing reservoir contamination and equipment damage. These fracturing fluids include materials like plant based gelling agents and other organic components that can be used as a food source for bacteria. Left untreated, bacterial contamination can create complications including corrosion of pipes, clogged wells, and infrastructure damage. These impediments can slow down production operations leading to costly remediation. It is far easier to kill bacteria in the frac fluids than remediate bacteria related problems in the formation or reservoir. To explain the scope of the problem, there are over 2,000 active fracturing rigs in US and Canada that are being moved about every 30 days. Each rig per location is using an estimated 4 to 6 million gallons of water, which need to be monitored and treated. According to the National Association of Corrosion Engineers (NACE) estimates total costs attributed to all types of corrosion are upwards of $200B. Microbiologically Influenced Corrosion (MIC) is estimated to account for as much as 40-50% of all internal corrosion.

RAPID-B answers the energy industry's need for a rapid, cost effective, onsite system that accurately enumerates the viable bacteria present in a fluid sample within 20 minutes of taking the sample. The RAPID-B system can provide valuable information that helps the operator treat each individual fluid source across the entire life span of a well; beginning with the drilling process and continuing on through the fracing, production and post-production cycles.

According to Kevin Kuykendall, Vivione's CEO, "Given our expertise in food safety and clinical applications, we believe if we treat oil wells with the same sensitivity that we do in testing meat, blood and urine, for the presence of dangerous pathogens, we can help oil and gas operators minimize and avoid costly complications. When we entered the Oil & Gas market with our innovative RAPID-B system, our strategy was to partner with forward-thinking, industry thought-leaders with a reference customer base who could readily appreciate the many benefits of our system. We strongly believe that AES Water Solutions is one of those organizations. We are very impressed with AES Waters' technology prowess and strong commitment to protecting the environment and their customers' assets. Their focus on using quantitative testing methods to assure their customers treatment plans are cost effective and individualized to meet the unique needs of each job. AES utilizes the AES HydroFlow chemical-free bacteria removal system on location to reduce bacteria encountered in ponds, tanks and during water transfer, prior to applying biocides. AES is employing the Rapid-B to analyze a baseline bacteria count in the water and subsequent remainder bacteria after treatment. The operator and stimulation service company have documented bacteria counts to determine the chemical dosing based on in-field data, which is a valuable improvement in the process, while saving considerable cost for bacteria removal. By using the RAPID-B technology, AES is setting themselves apart from other water management companies and oilfield service providers."

Mr. Kuykendall continued, "Due to the oil and gas industry facing current downward pricing pressures, it is imperative that operators and service companies are truly effective with water management activities. Microbial contamination can dramatically add to operating costs, asset replacement expenses, and curtail the ability to re-use water. Our strategic partnership with AES will deliver innovative technology to best address this significant issue."

Brent Mulliniks, AES Water Solutions President stated, "The challenge with any new, disruptive technology is to be able to quickly prove that it works. Studies and papers are great but there is nothing more powerful than taking a customer's sample and performing an immediate analysis in real time, on site, to show the nature and magnitude of the problem. We can then apply our technologies to kill bacteria and minutes later show that the customer's problem is solved using the RAPID-B system to prove the efficacy of our treatment technology. This gives our customers a lot of confidence and reinforces our image as being a technology and solutions driven organization."

Mr. Mulliniks continued, "AES Water Solutions is a total solutions provider for water management and oilfield services whose approach to water management is differentiate its frac water management services with new technologies enhancing value to its customers. The RAPID-B reinforces our ability to promptly provide customized customer solutions and prove their effectiveness on site in real time. Not only are AES's and Vivione's technologies highly compatible, our corporate cultures are as well, making for a powerful combination."

Monday, January 19, 2015

NIH awards $3MM Grant to Develop Rapid Diagnostic Test for Lyme Disease

Opko Health, Inc., a multinational biopharmaceutical and diagnostics company, and Immuno Technologies, Inc. announced that the National Institutes of Health (NIH) has awarded a $3 million grant to develop a rapid diagnostic test for Lyme disease. The phase II Small Business Innovation Research (SBIR) grant was issued to Immuno Technologies working in collaboration with Opko Diagnostics, LLC and Columbia University in the City of New York.

The goal of the grant is to develop a rapid diagnostic test based upon novel antigens that increase the specificity and sensitivity of the current laboratory assays and improve discrimination between early and late stage disease using Opko's Claros 1 in office analyzer. Combinations of these antigens have already been successfully demonstrated on Opko's microfluidic cassettes for the detection of Lyme disease using challenge panels from patients.

"Prompt diagnosis and treatment is critical to prevent disease progression, but current laboratory testing is difficult to interpret and time-consuming," said Maria Gomes-Solecki, president and CEO of Immuno Technologies, Inc. "The Claros 1 system can provide rapid, quantitative, multiplexed results, and coupled with well-selected antigens, can greatly improve diagnosis and management of Lyme disease."

"Our lab is pleased to participate in this collaboration to develop a point-of-care test for such a clinically important disease," said Samuel Sia, Associate Professor of Biomedical Engineering at Columbia University.

Lyme disease is a progressive disease with a wide array of largely non-specific clinical manifestations gradually developing from early to late stage. Moreover, Lyme disease is the most common tick-borne disease in North America and Europe and is one of the fastest-growing infectious diseases in the United States. According to recent estimates from the Centers for Disease Control, about 300,000 cases of Lyme disease occur in the United States each year.

"We look forward to development and commercialization of this breakthrough test that will address a large and growing global health challenge," said David Okrongly, president of Opko Diagnostics. "A rapid and more accurate in-office diagnostic for Lyme disease would be a game changer and help insure prompt and effective treatment for patients."

Immuno Technologies, Inc. focuses on translational research for infectious diseases. It does research and development of diagnostics and immuno preventive (vaccines) compounds.

Among the world's leading research universities, Columbia University in the City of New York continuously seeks to advance the frontiers of scholarship and foster a campus community deeply engaged in the complex issues of our time through teaching, research, patient care and public service.

DNAe Acquires nanoMR Own Complete Workflow for Point-Of-Need NGS-Based Blood-To-Result Diagnostic

DNA Electronics Ltd (‘DNAe’), the inventors of semiconductor DNA sequencing technology and developers of a new, revolutionary point-of-need test for blood infections, has on 15 January 2015 completed the acquisition of the entire issued share capital of nanoMR Inc. (‘nanoMR’), an Albuquerque based developer of a novel system for rapid isolation of rare cells in the bloodstream for a total cash consideration of approximately $24 million by way of a merger under the laws of Delaware, USA.

Integration of the two organisations is effective immediately, creating an 80+ strong team with facilities in the UK and the USA that will operate under the DNAe brand. The acquisition is a key strategic milestone for DNAe, enabling the Company to integrate nanoMR’s unique immunomagnetic Pathogen Capture System (PCS) with its own Genalysis® PCR and semiconductor-based DNA sequencing technology to create a complete blood-to-result solution.

The PCS can target multiple rare cell types such as those contained in bacteria and fungi from bloodstream infections at levels of 1 cell/mL or lower in less than 30 minutes, making it the ideal sample preparation technology for DNAe’s rapid point-of-need diagnostic tests. DNAe’s proven semiconductor DNA sequencing technology is already licensed to Thermo Fisher and is the core of the Ion Torrent™ Next Generation Sequencing (NGS) systems as well as to Geneu, a company selling the world's first in-store DNA test for personalised skincare.

DNAe is developing an integrated instrument and consumable cartridge that will deliver results directly from blood in 2-3 hours. Its first diagnostic product, a test for the rapid diagnosis of bloodstream infections, will identify pathogens in the blood as well as antimicrobial resistance genes. This will allow clinicians to treat patients with appropriate medication before the onset of sepsis, saving lives and reducing the time spent in hospital.

Professor Chris Toumazou, Chairman and CEO of DNAe said: “The acquisition of the nanoMR technology and team underscores our commitment to developing a complete point-of-need solution for diagnosis of infectious diseases, particularly those that cause sepsis, where speed and DNA-specific information can make the difference between life and death. nanoMR brings a game-changing technology, a wealth of scientific expertise and the potential for exciting new applications to DNAe.”

The combined company will continue to work on nanoMR contracts including the development of PCS and assays for potential infectious agents for the US Department of Health and Human Services Biomedical Advanced Research and Development Agency (BARDA) and will further invest in the development of PCS from its US facility. The UK-based operation will focus on developing Genalysis® technology as part of an integrated system.

nanoMR’s CEO Victor Esch said: “By combining our PCS technology with the powerful molecular diagnostic technology developed by DNAe we are in a strong position to create a blood-to-result system with unmatched versatility and performance. DNAe is the perfect match for nanoMR and we look forward to a great future as part of the combined team.”

DNAe is an ambitious company led by a highly experienced management team. It has strong financial backing, including major shareholder Genting Berhad, a Malaysian-based global investor with a growing portfolio of cutting–edge healthcare companies.

Tan Sri Lim Kok Thay, CEO and Chairman of Genting Berhad said: “This is a major value-creating deal for DNAe. The development of these ground-breaking technologies to address the huge unmet medical need for rapid point-of-need testing for sepsis, as well as other applications, makes it a stand-out company that we are proud to support. We are convinced that the acquisition of the nanoMR technology and the drive and commitment of the management team to accelerate development towards commercialisation will make a major contribution to the improvement of patient care.”

Friday, January 16, 2015

European Union Announces 8 New Projects for Ebola Vaccines and Rapid Diagnostics

The IMI Ebola+ programme was launched in response to the Ebola virus disease (EVD) outbreak that started in western Africa in 2014. The comprehensive programme contributes to efforts to tackle a wide range of challenges in Ebola research, including vaccines development, clinical trials, storage and transport, as well as diagnostics and treatments. It is hoped that the programme, which complements work being carried out with the support of other funding bodies, will help to make a difference in the current and future outbreaks. In addition to Ebola, the programme will also address related diseases, such as Marburg. Eight projects, with a total budget of over €200 million, have been selected for funding under the first Ebola+ Call for proposals.

Rapid Diagnostic Tests

There is an urgent need for fast, reliable tests to determine if someone is infected with Ebola or not. Three projects will pave the way for rapid diagnostic tests capable of delivering reliable results at the point of care in as little as 15 minutes.

Mofina

The Mofina project will develop a new diagnostic test that will deliver results in under 45 minutes on whether the patient has Ebola or a related disease such as Marburg virus. Crucially, the device is designed to work well in sites where high-end laboratory infrastructures are simply not available, while also protecting users from infection. The project will draw on two existing technologies: a conventional Ebola virus test, and a point-of-care molecular diagnostics platform. After testing a prototype of the system, the project partners will validate it in the field.

FILODIAG

The FILODIAG project aims to deliver an ultra-fast, accurate diagnostic instrument that will test for Ebola in under 15 minutes. Such a system could be used in both healthcare settings and at critical infrastructures like airports. Current tests for Ebola virus take a long time because samples must be heated and then cooled in each of the many processing cycles. This project will replace the heating/cooling steps with a technology based on laser-heated nanoparticles. Early tests of this technology have worked well. The project will add a step to concentrate the virus and refine and test the system before evaluating it in the field.

EbolaMoDRAD

The EbolaMoDRAD project aims to develop and validate in the field a rapid diagnostic tool that will be both simple and safe to use in low resource settings by people who may not have specialist training. At the same time, the project will implement a large-scale capacity building programme in West Africa with a strong focus on diagnostics, biosafety, and outbreak management. Finally, it will ensure its results are communicated widely, especially to public health bodies, charities, outbreak management teams, and local hospitals.

Future Plans

Further Calls for proposals under the Ebola+ programme are planned. These could address issues such as the development of a vaccine that offers broad protection against both Ebola and other, related viruses such as Marburg; the development of new treatments for Ebola; new vaccines that do not require extreme temperatures; and the generation of new diagnostic tests.

Thursday, January 15, 2015

PositiveID Readies Next Prototype for Handheld Pathogen Detector

A biological detection developer said Tuesday that it had completed the second-phase prototype design for a handheld pathogen-detection system.

PositiveID Corp. said it was the first major milestone in the development of its Firefly Dx product, which is a “real-time, handheld, polymerase chain reaction (PCR) pathogen-detection system.”

PositiveID already has started to build the prototype and expects to finish it in the first half of 2015. The company said it also expects the prototype to have the ability to test samples in less than half the time of its first prototype.

William Caragol, chairman and CEO of PositiveID, said the need for a product such as Firefly Dx is very high right now, and it can be used to detect a number of different pathogens.

“The market opportunities and critical need for a rapid diagnostic device like Firefly Dx, which can be used in the field without bulky lab equipment, are very significant,” Caragol said. “Whether utilized by the health care or defense communities for detecting various strains of influenza, biological weapons of mass destruction, Ebola, or other pathogens, Firefly Dx is designed to be a simple-to-use device that provides lab-quality, real-time PCR results anywhere, anytime, within minutes to save lives.”

PositiveID said that in the third quarter of 2014, it had accelerated the second-phase development of Firefly Dx and had partnered with Infinite Vision, a specialized engineering firm with expertise in biotechnology and medical devices.

“The company is now assembling the hardware components required to complete the second-phase device and build the prototype that demonstrates the functionality, speed, sensitivity and specificity of the Firefly Dx system,” PositiveID said.

Thursday, January 8, 2015

Real-time RT-PCR TaqMan Assay Discerns Latent TB Patients from those with Active Disease

Assay Accurately Differentiates Patients with Latent TB from those with Active Disease, According to Report in The Journal of Molecular Diagnostics

One of the roadblocks to the eradication of tuberculosis (TB) is the difficulty in identifying patients with latent TB infections (LTBI). Neither the tuberculin skin test (TST) nor interferon-gamma release assays (IGRAs) are capable of distinguishing active from latent infection or predicting the chance of reactivation. A new multiple-target, real-time reverse transcription-PCR (real-time RT-PCR) TaqMan assay targeting eight human immune markers can differentiate active pulmonary TB from LTBI, according to a study in The Journal of Molecular Diagnostics.

"The World Health Organization reports that one third of the world's population is latently infected with Mycobacterium tuberculosis (MTB). It has been estimated that in 5% to 10% of LTBI individuals, the infection progresses to an active disease state, and the conversion rate is greater in immunosuppressed individuals such as those with HIV," explains Hyeyoung Lee, PhD, of the Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University (Republic of Korea). "Therefore, rapid diagnostic tests and effective treatment of LTBI are important to reduce and control the TB burden."

In previous work, the researchers quantified interferon-g (IFN-g) mRNA expression levels as an indicator of IFN-g levels in an IGRA test. However, the results of IFN-g RT-PCR showed poor specificity and sensitivity, and the test could not be used to distinguish between active and latent TB.

With these results in mind, the investigators developed a multiple-target RT-PCR TaqMan assay that could target eight human immune markers: Th1-type factors (IFN-g, TNF-a, and IL-2R), Th2-type cytokines (IL-4 and IL-10), and IFN-g-induced chemokines [CXCL9 (MIG), CXCL10 (IP-10), and CXCL11 (I-TAC)]. MTB-specific, antigen-dependent mRNA expression levels were measured in blood samples from 28 patients with active pulmonary TB, 22 with LTBI, and 29 non-TB controls.

When five of the human immune markers were evaluated individually, three were found to be suitable for detecting active pulmonary TB: TNF-a, IL-2R, and CXCL10, with sensitivities ranging from 96.43% to 100%. Two individual markers, IL-2R and CXCL10, were able to detect LTBI, with sensitivities of 86.36% and 81.82%, respectively.

To optimize sensitivity, Dr. Lee and her colleagues used the assay to simultaneously detect multiple targets. They found that the combination of TNF-a, IL-2R, CSCL9, and CSCL10 could differentiate active pulmonary TB from healthy controls (P <0.001) and LTBI from healthy controls (P <0.01). More importantly, the combination could differentiate those with active pulmonary TB from those with latent infection (P <0.01). The combination had a sensitivity of 100% for active disease and 81.82% for LTBI. "These results imply that a combination of suitable single markers is very useful for the efficient diagnosis and differentiation of MTB infection," says Dr. Lee.

In a commentary published in the same issue of The Journal of Molecular Diagnostics, David H. Persing, MD, PhD, Executive Vice President and Chief Medical and Technology Officer of Cepheid, Inc., Sunnyvale, CA, notes that the work by Dr. Lee and colleagues presents an interesting and potentially promising alternative approach to measure immune responses to MTB.

Dr. Persing underscores the healthcare threat resulting from the burden of future TB cases emerging from within the latent pool. He highlights some of the shortfalls of TST, mainly the risk of false-positive results in patients who have received the bacille Calmette-Guérin vaccine and the need for skilled interpretation of the results in a follow-up visit. He cautions that IGRAs are also limited by their potential for false-positive and false-negative results, are technically challenging to perform reproducibly, and have less than ideal sensitivity, especially in those who are immunologically compromised.

"It is possible that one day a combination of selected antigen stimulation with multiplexed cytokine, chemokine, and interferon mRNA detection will lead to new ways of evaluating suspected TB patients for current and future disease risk," comments Dr. Persing. "With one third of the world's population at risk for recurrence, the investment in such technology is recommended."

Alere Receives FDA CLIA Waiver for Alere™ i Influenza A & B Test

Alere Inc., a global leader in rapid diagnostic tests, today announced that the U.S. Food and Drug Administration (FDA) has granted CLIA waiver for the Alere™ i Influenza A & B test, the only molecular test to detect and differentiate influenza A and B virus in under 15 minutes. Alere i Influenza A & B is the first-ever molecular test to receive a CLIA (Clinical Laboratory Improvement Amendments) waiver, which allows for broad use by healthcare providers, ranging from hospitals and physician offices to clinics and other healthcare settings.

"This milestone greatly expands the availability of molecular testing to a wide range of healthcare settings during this influenza season," said Avi Pelossof, Global President of Infectious Disease at Alere. "By making lab-accurate, actionable results available at the point of care, Alere i empowers healthcare providers to quickly identify and treat people with influenza – improving patients' clinical outcomes, protecting their communities, and reducing healthcare costs."

The Alere i test was cleared for marketing by the FDA in June 2014, and was made available in September for health facilities and laboratories licensed to conduct tests of moderate complexity under the CLIA program. With CLIA waiver, the test will be available in a significantly broader range of healthcare settings.

About the Alere i Influenza A & B test

Molecular testing involves the extraction and analysis of DNA or RNA strands to detect sequences associated with viral and bacterial causes of infections. Alere i Influenza A & B is the first molecular diagnostic test that delivers actionable, lab-accurate results in less than 15 minutes on a user-friendly platform. Unlike polymerase chain reaction (PCR) testing, Alere's proprietary Molecular. In Minutes™ (MIM) isothermal nucleic acid amplification technology (iNAT) does not require lengthy and complex thermo cycling or DNA purification, and can therefore deliver PCR-caliber results more quickly – and in a broad range of settings.

The clinical performance of Alere i Influenza A & B was established in a multi-center study conducted in the U.S., in which 630 nasal swab specimens, were evaluated with Alere i, and compared to an FDA cleared Real-Time PCR (RT-PCR) assay.

Additional tests on the Alere i platform are currently in development. Alere recently filed a 510k application for Strep A, and the company is planning to initiate clinical trials for a respiratory syncytial virus (RSV) test during the current respiratory season.

Tuesday, January 6, 2015

3M Food Safety Launches 24-Hour Aerobic Bacteria Indicator Test

Thirty years ago, 3M launched its first 3M Petrifilm Plate, the 3M™ Petrifilm™ Aerobic Count Plate, ushering in a solution that has been widely viewed as a step forward in ensuring the quality and safety of food manufacturers’ products and freeing space and productivity in their labs. Today, 3M Food Safety builds on that legacy by announcing the global launch of the 3M™ Petrifilm™ Rapid Aerobic Count Plate, the next generation of its trusted, accurate and easy test that can detect aerobic bacteria counts in just 24 hours for most food matrices.

The ability to accurately and efficiently enumerate aerobic bacteria is important to food and beverage processors, who need to make time-sensitive decisions critical to ensuring their product quality and the stability of their manufacturing processes. Proven to be as reliable as Standard Methods Agar, the 3M Petrifilm Rapid Aerobic Count Plate offers a faster time-to-result, technology that reduces the impact of spreader colonies, and a simplified inoculation area to drive greater efficiency and reduce costly retesting and delayed results. 3M Petrifilm Rapid Aerobic Count Plates also leverages a dual-sensing indicator technology for easy enumeration of colonies in raw material, in-process and finished product food testing as well as environmental air, swab or surface contact testing.

The new 3M Petrifilm Rapid Aerobic Count Plate has received certification (#121403) from the AOAC® INTERNATIONAL Performance Tested Methods℠ (PTM) program inserts. Specific studies performed as part of this certification involved comparison tests to the FDA BAM and USDA reference methods, along with robustness and lot-to-lot/stability testing.

“We are proud to be taking yet another innovative step forward with the seventeenth addition to the 3M Petrifilm Plate portfolio and our tenth product offering that delivers results in 24-hours or less,” said Jason Semerad, global marketing manager, 3M Food Safety. “Ultimately, this is about saving food and beverage processing plants time and capital while maintaining the highest degree of accuracy and reliability to ensure customers and their hard-earned brand equity are protected.”

Today, 91 of the top 100 U.S. food processing companies rely on 3M for their indicator testing needs. The sample-ready system uses an easy three-step process: Inoculation, Incubation and Enumeration. The system contains nutrients, a coldwater-soluble gelling agent, and a dual-sensing indicator technology that facilitates colony enumeration for most food matrices. Incubation temperatures are 32°C or 35°C.