Thursday, August 30, 2012

Rapid Diagnosis of Pneumonia Vital for Best Possible Outcome


Researchers at NUI Galway are involved in a new European project which hopes to deliver a cost effective tool for the speedy diagnosis of infections such as pneumonia.

The test would reduce diagnosis time from days to hours, so that the appropriate treatments can be administered as early as possible for the best possible outcome.

Respiratory tract infections, such as pneumonia, are amongst the top four major causes of morbidity and mortality worldwide. According to the World Health Organisation, pneumonia is the leading cause of death in children, killing an estimated 1.4 million children under the age of five each year.

“There is an urgent need for rapid diagnostic tests capable of identifying the large range of microorganisms and antibiotic resistances involved with infection”, explains Dr Thomas Barry of the Molecular Diagnostics Research Group at NUI Galway. “Speed and accuracy are key to appropriate therapy and survival of the patient. The ultimate objective is to develop new cost effective, user-friendly products that will be routinely used in hospitals. This could replace time-consuming and labour-intensive methods so that a diagnosis can be achieved within a couple of hours, rather than days or weeks.”

The diagnostic products for the rapid diagnosis of Respiratory Tract Infections, specifically pneumonia, will be based on a novel ‘sample-in, result-out’ technology platform.

The Molecular Diagnostics Research Group (MDRG) at NUI Galway is part of an international consortium involved in the project, funded by the EU's Seventh Framework Programme for Research and Development (FP7). A total grant of €6 million was awarded with the contribution to NUI Galway close to €1 million. The project, Rapid Identification of Respiratory Tract Infections (RiD-RTI), represents a unique partnership of SMEs, universities and hospitals from four European countries.

The MDRG at NUI Galway joins University College London, the French diagnostic company Genewave, the Finnish Biotech company Mobidiag, and Assistance Publique Hopitaux de Paris in this consortium.

The NUI Galway project component is led by Dr Thomas Barry, Principal Investigator of the MDRG which is based in Microbiology along with Dr’s Nina Tuite and Kate Reddington.

"Real-Life Tricorder" to be Tested on International Space Station


While still impressive, the capabilities of early "tricorders," such as the Scanadu and Dr Jansen's tricorder, fall well short of the Star Trek device that inspired them. But new technology to be tested on the International Space Station (ISS) brings the age of instant diagnosis of medical conditions using a portable device a step closer. The Microflow could also make its way into doctor’s offices here on Earth where it might help cut down on the number of follow up visits required after waiting to get results back from the lab.

The Microflow is a miniaturized version of a flow cytometer, which analyzes cells suspended in a stream of fluid as they pass single-file in front of a laser. As the suspended particle passes through the beam, various detectors positioned where the stream meets the laser can analyze the physical and chemical properties of the molecules or cells in the stream. Because they work in real-time, flow cytometers offer diagnosis in just 10 minutes of everything from infections, to stress, blood cells and cancer markers. They can also identify bacterial pathogens in food or water.

Despite the technology first being proposed in the 1950s and their forerunners appearing in the 1960s, modern flow cytometers are generally still only found in labs because they are bulky and can weigh hundreds of pounds – until now.

With the Micoflow, researchers at Canada’s National Optics Institute (INO) have managed to shrink the flow cytometer down to device the size of a toaster that weighs less than 10 kg (22 lb). Tasked with developing a portable technology that worked in space, the INO team needed to find a way to keep the fluid stream from becoming unfocused in the weightlessness of space.

The answer was to suspend a tiny amount of liquid containing the particles to be analyzed inside a small fiber-optic structure that is permanently focused. After the device detects the particles, the collected data is transferred to a USB key for analysis.

A Microflow technology demonstrator will be carried to the ISS by Canadian Space Agency (CSA) astronaut Chris Hadfield in December, 2012. If it functions in space as expected, it will provide astronauts with the ability to diagnose and treat themselves on long-duration missions without having to send samples back to Earth for analysis.

The technology also has obvious applications back on Earth, with the rapid testing of remote communities and disaster sites for infectious and other diseases providing an increased level of care while reducing costs. The INO says the technology could also be used for on-site quality-control inspections and tests in food and agricultural processing plants.

Charles River Acquires Accugenix


Charles River Laboratories International, Inc. announced that it has acquired Accugenix, Inc., the premier global provider of cGMP-compliant contract microbial identification testing, for approximately $17 million in cash. This acquisition strengthens Charles River's Endotoxin and Microbial Detection(1) (EMD) portfolio of products and services by providing clients with state-of-the-art microbial detection services for manufacturing in the biopharmaceutical, medical device, nutraceutical and consumer care industries. The acquisition is expected to be neutral to earnings per share on both a GAAP and non-GAAP basis in 2012. In 2013, it is expected to represent approximately 1% of total net sales and be slightly accretive to both GAAP and non-GAAP earnings per share.

Accugenix is an acknowledged industry leader in species-level identification and strain typing of bacteria and fungi that are recovered from manufacturing facilities. The company has invested in proprietary library databases which allow it to identify over 5,000 species of organisms. Utilizing state-of-the-art and proprietary in vitro technologies, coupled with scientific expertise and analysis, Accugenix excels in providing accurate, time-effective and cost-effective microbial identification services required to meet internal quality standards and government regulations.

James C. Foster, Chairman, President and Chief Executive Officer of Charles River said, "The acquisition of Accugenix is the first step in our broader strategy to become the premier provider of rapid microbial and endotoxin detection products and services to the biopharmaceutical industry. Over the next several years, we intend to enhance our capabilities through both product extensions and acquisitions. We believe that execution of this strategy will advance our position as the market leader in endotoxin and microbial detection."

Monday, August 27, 2012

NanoLogix Rapid Diagnostic Technologies Set to Enter Market Under FDA 510K-Exempt Status


NanoLogix, a biotechnology innovator in the rapid detection and identification of live-threat bacteria and microorganisms, announces it will begin commercialization of its BNP (BioNanoPore) and BNF (BioNanoFilter) diagnostic kits under FDA 510K-exempt status. The first product to be marketed will be the Petri-based BNP detection kit utilizing TSA media. Other nutrient media will be available by special order. Recently completed independent third-party research has demonstrated BNP diagnostic kits to be two to ten times faster at live bacteria detection than traditional methods. Following the BNP rollout, NanoLogix plans to commercialize its BNF technology, which third-party research documents as 18 to 72 times faster than conventional detection and identification methods. The company also plans to develop customized test kits for particular applications and client partners.

NanoLogix is also beginning sales of conventional TSA Petri plates. Both BNP kits and NanoLogix TSA Petri plates will be packaged in the company's proprietary inert-gas charged vacuum Flat Packs. A major third-party laboratory has documented these Flat Packs to have at least a one-year shelf life stored under normal conditions, compared to the 3-month shelf life of traditional Petri plates.

InGen BioSciences Inks Distribution Pact with Quidel and Diagnostic Hybrids in France


InGen BioSciences has signed exclusive distribution agreements in France with two major international players in the field of diagnostics in vitro, Quidel and Diagnostic Hybrids.

“These exclusive partnerships enable Ingen BioSciences meet the unmet needs of French biologists in the early detection of infectious diseases, bacterial or viral, to bring a pregnancy test effective and fast, and thus assist physicians in personalized care to their patients,” says Isabelle Buckle , CEO of InGen BioSciences.

Quidel Corporation (San Diego, California, USA) is a leader in rapid diagnostic tests. He chose the expertise of InGen BioSciences for distribution in France, of 14 of its tests showing a result in three to 15 minutes on seven different parameters in the fields of infectious diseases and reproductive health.

“The Quidel's product portfolio, marketed under the brand name of QuickVue, currently includes diagnostic tests for influenza, respiratory syncytial virus, Strep A, Infectious Mononucleosis, of Helicobacter pylori, Chlamydia and testing of pregnancy,” said Douglas Bryant, CEO of Quidel Corporation. “We are delighted with the opportunities we offer the expertise of InGen BioSciences for marketing our rapid diagnostic reagents in France.”

Diagnostic Hybrids (Athens, Ohio, USA) is a pioneer in the development of molecular virology tests, Quidel integrated. Diagnostic Hybrids has signed a strategic partnership with InGen Biosciences for marketing its tests Direct Fluorescent Antibody and Culture (DFA) that allow physicians to identify eight major respiratory viruses, including influenza virus, Influenza A H1N1, Metapneumovirus and three families of herpes virus (Herpes Simplex Virus, Cytomegalovirus, Varicella-zoster virus).

The group InGen BioSciences is a company flexible, responsive, customer-centric and in search of best innovations (in products and services) to meet the needs of doctors and biologists for their patients; InGen BioSciences develops and markets diagnostic kits in vitro and advanced controllers for clinical use (proprietary or licensed).

Affymetrix And Singapore-Based Start-Up PathGEN Dx Sign Partnership For Diagnostic Test Development For Pathogen Detection


Affymetrix, Inc. and PathGEN Dx Pte. Ltd., a spin-off molecular diagnostics company founded by researchers from the Genome Institute of Singapore, today announced they have signed aPowered by AffymetrixTM (PbA) Program agreement.

Under this PbA agreement, PathGEN Dx will develop an in-vitro diagnostic kit for comprehensive pathogen detection using their PathGEN® PathChip and is based on a patented, efficient, and accurate microarray-based protocol and analysis method. The kit will be comprised of PathGEN Dx’s proprietary reagents, an automated software package, and a contract manufactured GeneChip®microarray from Affymetrix. It will detect the presence of more than 70,000 viral and bacterial genomes from a wide variety of human samples, annotate the genomic information, and identify co-infecting pathogens.

Dr. Martin Hibberd, PathGEN Dx Co-Founder, said, “This will be the start of our development plan for a diagnostic microarray that we feel will ultimately help medical researchers and surveillance investigators identify the full range of viruses and bacteria in their samples.”

“We are very pleased to have PathGEN Dx join the Affymetrix’ PbA Program. This adds significantly to our PbA Program in which we help partners to develop novel molecular diagnostic tests that will potentially provide solutions for directing proper treatment for patients,” said Roger Schaller, Sr. Director of Global Business Development for Clinical Applications at Affymetrix.

“We are very proud that PathGEN Dx, the first spin-off from GIS, has achieved this collaboration that will significantly advance their reach to the clinical diagnostics global market. The journey first began in 2004 as a project in GIS, and then funded by Exploit Technologies in 2008 to clinically validate, productize, and develop the business strategy. This is an exciting next phase in PathGEN DX’s entrepreneurial journey and we look forward to greater success,” said Mr. Philip Lim, CEO of Exploit Technologies, A*STAR’s technology transfer arm.

“The Genome Institute of Singapore is pleased to support PathGEN Dx and look forward to incubating more startups in the future,” said Prof. Ng Huck Hui, Acting Executive Director of GIS.

This PbA Program agreement also provides PathGEN Dx access to Affymetrix’ international distribution network.

Dr. Christopher Wong, Founder of PathGEN Dx, added “We are pleased to join the ranks of other PbA Program partners, such as Roche Diagnostics and Pathwork Diagnostics in adopting the Affymetrix technology in our IVD product development program.”

Homeland Security Tests to Begin at T Stops in Cambridge, Somerville


The federal government Wednesday will begin releasing bacteria at Red Line MBTA stations in Cambridge and Somerville at set times to test sensors designed to detect biological agents that could be released in a terrorist attack.

The U.S. Department of Homeland Security and the Massachusetts Bay Transportation Authority said in a press release Monday that the harmless bacteria is non-infectious and the tests will be performed when the stations are closed.

The tests will begin Wednesday and will be held periodically over the next year at the Harvard and Porter Square stations in Cambridge and the Davis Square station in Somerville.

Signs will be posted in the MBTA stations one day before each scheduled test, according to the federal agency.

Biological detection sensors have been installed at the stations and the tests are being conducted in an effort to detect and minimize any impacts from an attack or accident involving hazardous biological materials in a mass transit system.

“A rapid alert from a detection system can locate and identify these materials and provide for immediate and appropriate response to protect people and contain the hazard,” stated DHS scientist Anne Hultgren in the agency's press release.

State and local health officials along with DHS and the MBTA held a public meeting in Cambridge in May to discuss the tests, and said that there was no known threat of a biological attack on subway systems in the Boston area or elsewhere, but the systems are vulnerable to such a strike.

“This detection system will be one of the first such installed in the country, and, if it proves to be effective, could serve as a model for other mass transportation venues throughout the nation and the world,” said MBTA Transit Police Chief Paul MacMillan in the joint press release Monday.

State health officials will be working with the DHS and MBTA to monitor the results of the tests. According to DHS, the bacteria that will be used is non-infectious and is approved as a food supplement. An environmental assessment of the tests planned for the MBTA stations found no significant impact on human health or the surrounding environment from the use of the testing material.

Friday, August 17, 2012

Accelr8 Technology Corporation Announces Headquarter Relocation To Tucson, Arizona


After a competitive multi-state process, Accelr8 Technology Corporation announced that it is moving its headquarters from Denver, CO to Tucson, AZ.

Founded in 1982, Accelr8 develops instruments used for the detection of pathogenic microorganisms. Its BACcel™ rapid diagnostic system, in development, is the first technology that is able to count and identify dangerous pathogens and their drug resistance expression within the same day of obtaining a patient specimen, instead of the two to three days required for standard methods. This speed allows for a significant improvement in the treatment of the over 1.7 million people in the US who contract a hospital acquired infection each year, and access to a multi-billion dollar market.

Accelr8 has selected Tucson as best meeting its needs for future high-growth plans. Accelr8 will bring high-skilled, high-wage jobs to Southern Arizona with plans to fill 65 positions over the next three years and the potential to grow to 200-300 employees in subsequent years. Headquarter positions include engineers, scientists, sales/marketing, management, finance, quality/regulatory and manufacturing. The company will occupy approximately 15,000 square feet of space in Pima County’s Herbert K. Abrams Public Health Center at 3950 S. Country Club Road. After a build out of wet lab space, the company is expected to be operational by early 2013.

“Accelr8 is developing a revolutionary product in the diagnostics area and we were impressed with the region’s emerging bioscience strength, innovation and support that can help ensure our future success,” said Lawrence Mehren, president and CEO, Accelr8 Technology Corporation.

“Accelr8 strengthens the biotechnology excellence our state has been building, while creating high-quality jobs for Arizonans,” said Governor Jan Brewer. “I am grateful to the Arizona Commerce Authority, TREO and other regional partners whose excellence and creativity produced infrastructure solutions to secure Accelr8 for Arizona.”

“We’re thrilled to attract a publicly-traded headquarters in a key, targeted industry,” said Joe Snell, president & CEO, TREO. “Accelr8 represents another building block as we emerge as a leading biotech hub.”

Wednesday, August 15, 2012

SIRS-Lab Completes Enrollment in Clinical Trial to Evaluate Pathogen Detection Test VYOO® for Patients with Suspected Sepsis


SIRS-Lab, the innovative molecular diagnostics company specialized in sepsis, today announced the successful completion of recruitment in its 1’000-patient trial. The prospective, blinded multicenter study involved 13 key medical centers across Germany and focused on ICU patients. Results are expected in early 2013. The evaluated VYOO(R) test detects the presence of genetic material from a broad panel of pathogens in whole blood, faster than current methods. The test covers bacteria, fungi and genes associated with antibiotic resistances. In parallel, further development for a new version of VYOO(R) was completed.

Principal Investigator of the trial, Professor Tobias Welte of the University Hospital in Hannover: “Detection of the sepsis-causing pathogen is an important prerequisite for choosing the adequate antibiotic or antifungal therapy, a key step for the survival of the patient. The trial is the first of its kind and of remarkable magnitude for molecular diagnostic testing for sepsis. It will deliver data about test utility compared to conventional methods to identify microbes in ICU patients with suspected sepsis.”

Barbara Staehelin, CEO of SIRS-Lab, about the study: “With the full enrollment of the trial, we reached one of the most important milestones in compiling the data for the market launch of our test. The centers have proven exceptional motivation throughout the trial and we are grateful to be so generously supported by the sepsis community. Together, we strive to lower the burden of this cruel disease.”

At present, traditional diagnostic methods often cannot identify the microbe responsible for the infection and can take several days to complete. Molecular diagnostics like VYOO(R) offer the possibility to test for a panel of microbes within a much shorter time. The results offer same-day, reliable and valuable additional information for clinicians, allowing rapid tailoring of the patient’s therapy.

During the study, SIRS-Lab has continuously invested in further automation of VYOO(R), reducing hands-on time for laboratory technicians to 70 minutes per run with an overall test time of 7 hours. The user gets the results data through software, fully integrated on the microarray reader. On-board positive and negative controls ensure test performance. SIRS-Lab obtained European marketing clearance (CE mark) for the current VYOO version in May 2012.

Sepsis occurs when microbes enter the bloodstream and trigger a severe inflammatory response by the patient’s body. This is often life threatening, and the search for the appropriate antibiotic or antifungal treatment can be a race against time. This is a challenging area for new diagnostics because the amounts of bacteria or fungi that cause the disease are extremely small. Sepsis affects more than 2 million people per year and is the second leading cause of death in hospitals.

Headquartered in Jena, Germany, with offices in Basel, Switzerland, SIRS-Lab is a molecular diagnostic company that develops and commercializes unique and innovative products to identify and monitor life-threatening infections, as well as technologies to enhance the performance of microbial molecular tests in a variety of fields. The company has developed a proprietary sample preparation technology LOOXSTER(R), that can increase the sensitivity of molecular assays for pathogens: This is used within VYOO(R), SIRS-Lab’s CE-marked molecular diagnostic test for blood-stream infections in hospitals.

BD MAX™ MRSA Assay Receives a CLIA Moderate Complexity Rating


BD Diagnostics, a segment of BD (Becton, Dickinson and Company), today announced that the new BD MAX™ MRSA molecular test has received a Moderate Complexity rating under the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88). Performed on the fully-automated BD MAX™ System, the assay is designed to rapidly and accurately identify patients colonized with methicillin-resistant Staphylococcus aureus (MRSA). A Moderate Complexity rating allows the BD MAX MRSA assay to be performed by a qualified laboratory technician.

"The BD MAX MRSA assay enables efficient use of labor in the laboratory," said Tom Polen, President, BD Diagnostics – Diagnostic Systems. "Healthcare institutions can now simplify and optimize their MRSA active surveillance testing in less than a minute of hands-on time per specimen with true walk-away automation."

According to a recent national survey conducted by the Association for Professionals in Infection Control and Epidemiology, more than three quarters of healthcare facilities in the United States now conduct active surveillance testing to detect patients colonized with MRSA. Active detection and isolation of MRSA-colonized patients have been shown to help prevent transmission and reduce the rate of MRSA infections in hospitals. Rapid detection with molecular methods helps decrease unneeded preemptive isolation and shortens the time that patients are not properly isolated.

Earlier this year, the BD MAX™ GBS assay for Group B Streptococcus received a Moderate Complexity rating. The BD MAX MRSA is the next assay to receive a Moderate Complexity rating. "This latest achievement further emphasizes our commitment to deliver a broad menu of molecular tests with a simplified, standardized workflow to help laboratories better meet the needs of healthcare providers," said Polen.

BD MAX is the first and only fully automated, bench-top molecular system designed to perform a broad range of molecular tests. This includes in vitro diagnostic assays, as well as user-defined protocols and life science research applications. BD MAX GBS and BD MAX MRSA assays are commercially available in the United States today, and more than 15 state-of-the-art assays are currently under development.

Saturday, August 11, 2012

Groups Slash Cost of Advanced TB Test for Developing Countries


An important new diagnostic test for tuberculosis is about to become more affordable where it’s needed most — in the developing world.

The U.S. government, the Bill & Melinda Gates Foundation and UNITAID, a global health-funding initiative, announced a plan this week to reduce the cost of cartridges for the test by 41% for 145 countries where the burden of tuberculosis is high. Cartridges for the Xpert MTB/RIF rapid diagnostic test will be $9.98 now in those countries as of Aug.6, down from $16.86. The prices will hold until 2022, the partners said.

The idea is to bring the cost more in line with that of the currently used method of diagnosing TB. The Xpert assay, developed by Cepheid, represents the first major advance in TB diagnostics in more than a century, reducing diagnosis of TB to hours from weeks.

The only method used in most laboratories in the developing world has been smear microscopy, developed in the 1880s. It requires visual detection of the TB bacterium under a microscope — and it easily misses TB in the millions of patients who are infected with HIV. TB is the leading cause of death among people living with HIV in Africa. Smear microscopy also can’t detect drug-resistant strains of TB, which are an increasing concern.

“We’ve seen Xpert as a real breakthrough, but the next thing is it has to be taken to scale,” says Joanne Carter, executive director of Results and Results Educational Fund, an advocacy organization that fights hunger and poverty globally. “Price has been a significant barrier to date.”

More than 8.8 million people were sickened with TB in 2010, with nearly 1.5 million deaths, according to the World Health Organization.

The price reduction won’t apply to all purchasers of the cartridges in developing countries, meaning they could still remain pricey in the private sector. And the price of the diagnostic machines themselves will still make the system unattainable for many in developing countries, said the Treatment Action Group, an independent AIDS research and policy think tank, and the European AIDS Treatment Group, a community organization.

Still, reducing the price of cartridges should help stimulate further investment as well as research and development, Carter said.

The U.S. government (including the U.S. President’s Emergency Plan for AIDS Relief and the Agency for International Development) and the Gates Foundation are investing $3.5 million each in the venture, though the final amounts from all partners will depend on the volume of cartridges sold.

Thursday, August 9, 2012

3M Software Boosts Contamination Detection


3M Food Safety has upgraded its Hygiene Monitoring System to improve identification of cleanliness and sanitation programs for the food and beverage industry.

3M’s Clean-Trace Data Trending Software Version 5.03 will help food and beverage processors to track and monitor cleaning and sanitation within manufacturing environments, claims the firm. Samples are taken using the Clean-Trace ATP Test Swabs, which are wiped on suspect surface areas to collect residues that may contain adenosine triphosphate (ATP), an energy molecule prevalent in organic materials.

Rapid Evaluation

The hardware, called the 3M Clean-Trace NG Luminometer, rapidly evaluates the sample and determines the presence and magnitude of potential contamination. The handheld Luminometer delivers a result in seconds and allows users to preselect their own “pass, caution or fail” levels, said the company. The Luminometer is docked to a computer or connected via USB cable and works with the software to allow users to make business decisions and comply with audit requirements.

“The Clean-Trace Data Trending Software allows customers around the world to almost instantly pinpoint where a sanitation problem occurs and address it at the source,” said Tom Dewey, 3M Food Safety global marketing manager. “Not only do they find contaminants in the manufacturing line, they can systematically identify trends with equipment, work crews and processes – even predict where future issues could happen.”

E. coli Test Validation

Meanwhile, 3M Food Safety has also announced it has received AOAC-PTM Certification (#071202) for its 3M Molecular Detection Assay for E.coli O157 (including H7) from the AOAC Research Institute’s Performance Tested Methods Program. The certification gives food processors greater assurance in safeguarding against pathogenic E.coli, said 3M. Sample food groups evaluated included raw ground beef, bagged spinach and sprouts.

The Molecular Detection System combines isothermal DNA amplification and bioluminescence detection to provide pathogen discovery in enriched food, feed and food process environmental samples. The PTM validation of E.coli O157 follows an earlier validation of the Salmonella assay from the AOAC Research Institute.

Wednesday, August 8, 2012

Invisible Sentinel Announces Product Launch of Its Foodborne Pathogen Specific Monoclonal Antibodies


Invisible Sentinel Inc., a life sciences company that develops rapid diagnostics for the detection of foodborne pathogens, announced today the availability of a suite of monoclonal antibodies specific for the four most prevalent bacterial foodborne pathogens. The antibodies detect E.coli O157, Listeria monocytogenes, Salmonella enterica, and Campylobacter jejuni, and are available for purchase on the Company's website.

The antibodies, produced in the Company's laboratories, will complement Invisible Sentinel's first-in-class diagnostic technologies that are planned to launch this Fall. The initial monoclonal products released are an important tool for the detection of foodborne pathogens, and can be utilized in research applications that require specificity and sensitivity. The Company plans to release additional specialty reagents to further accelerate research into microbial contamination and rapid detection strategies.

"We are committed to developing innovative technologies in food safety and are pleased to announce the availability of our specialized monoclonal antibody line," said Benjamin Pascal, CEO and co-founder of Invisible Sentinel. "The commercialization of our proprietary antibodies marks another important milestone for the Company during a very exciting Summer. We are currently seeking regulatory approval for our first-in-class diagnostic technology and anticipate commercialization of our diagnostic kits as early as this Fall."

Invisible Sentinel's ability to internally produce monoclonal antibodies helps to accelerate diagnostic development and expands the Company's product portfolio of innovative food safety technologies. The Company's patented and patent-pending diagnostic technology is designed to address the growing need for rapid, practical, and cost-effective detection methods for foodborne pathogens at the point of care.

The food industry is the first market that the Company is targeting, but its platform technology has the potential to provide valuable tools for additional industries including healthcare, veterinary, biodefense, and environmental testing, where rapid detection of target pathogens from unrefined samples is critical.

ABOUT INVISIBLE SENTINEL Based in Philadelphia, Invisible Sentinel develops diagnostic technologies for a safer food supply. The Company's focus is on developing rapid diagnostics that quickly provide accurate information about the presence of harmful pathogens. Uniquely designed for easy, practical use -- on-site and throughout the entire food distribution network -- Invisible Sentinel's proprietary diagnostic products promise to create a new standard for rigorous quality control.

Tuesday, August 7, 2012

Idaho Technology Provides FilmArray(R) Clinical Diagnostic Pipeline Update


Idaho Technology, Inc., a privately held clinical diagnostics company dedicated to providing the world's fastest, highest-quality instruments for pathogen identification and DNA analysis, today provided a development update on the Company's pipeline of clinical diagnostic test candidates, which are based on the Company's FilmArray system. Recently, the Company and its collaborators presented preliminary assessments of Idaho's development-stage blood culture ID (BCID) and gastrointestinal (GI) panels at the 2012 American Society for Microbiology (ASM) General Meeting in San Francisco, California. These panels represent Idaho Technology's most advanced clinical diagnostic test candidates, which pending successful clinical trials, will expand the current test menu for FilmArray, which includes the Company's FDA-cleared, CE IVD marked respiratory panel, FilmArray RP.

Kirk Ririe, Chief Executive Officer of Idaho Technology, said, "We are pleased to report these encouraging findings, which demonstrate the broad applicability of our FilmArray rapid diagnostic platform. We recently initiated clinical trials for our BCID panel and expect to launch the clinical evaluation for our GI panel in the first quarter of next year. Pending regulatory clearance, we expect the BCID panel to be available commercially in the U.S. and Europe in the first half of 2013 and the GI panel to follow early in 2014."

FilmArray BCID

The Company's BCID panel is designed to identify the numerous organisms that can cause sepsis, as well as detect the presence of selected antibiotic resistance genes. The FilmArray BCID panel is designed to detect about 90% of the pathogens isolated from positive aerobic blood cultures. Preliminary results when testing residual positive blood cultures at three external sites with a beta version of the FilmArray BCID panel showed good concordance between the FilmArray result and the gold standard of culture and biochemical identification. Rapid identification of a large range of pathogens in blood culture could improve the medical management of sepsis. The current version of FilmArray BCID tests simultaneously for eight Gram-positive and eleven Gram-negative bacteria, five yeast pathogens, and four antibiotic resistance genes. Given the promising results of the beta evaluations, clinical trials for the FilmArray BCID panel have been initiated with the goal of establishing the true product performance and to obtain FDA clearance and CE IVD marking for the FilmArray BCID panel.

FilmArray GI

The Company's GI pathogen detection system aims to rapidly identify GI pathogens from minimally processed stool samples. The current development version of the panel simultaneously detects 25 different diarrheagenic pathogens including bacteria, viruses, and protozoa. In one early phase study, de-identified patient stool specimens submitted for standard-of-care testing were re-tested using FilmArray GI. In this initial evaluation, the FilmArray GI panel had good concordance with standard clinical testing. In addition, because the multiplex testing with FilmArray GI panel is able to detect several pathogens from a single patient sample, the number of pathogens identified as compared to the pathogens identified when the same samples were tested according to individual tests ordered by physicians was significantly higher. These results highlight the potential advantage of simultaneous multiplex pathogen detection using FilmArray GI, which is able to identify pathogens for which pathogen-specific testing was not requested or is not currently available.

In a second early phase study, the ability of FilmArray GI to detect Clostridium difficile infection (CDI), the leading cause of diarrhea with rising incidence and mortality, was examined. This study also demonstrated good concordance between the results of the FilmArray GI panel when compared to the result obtained from an FDA cleared molecular assay. As with the previous study, in addition to detecting C. difficile, the FilmArray GI panel was able to detect other pathogens known to cause diarrhea both in samples that tested positive for C. difficile and those that tested negative for C. difficile. These data suggest the use of a multiplex system like FilmArray GI may be beneficial in rapidly and accurately diagnosing diarrheal infections.

The FilmArray GI and BCID panels are currently not FDA cleared or CE IVD marked, are not for use in clinical in vitro diagnostic procedures, and are not currently commercially available.

Mr. Ririe concluded, "In addition to our clinical diagnostic pipeline, we continue to gain significant traction in the market with placements of our FilmArray RP only one year since its commercial launch. As a profitable clinical diagnostics company, we are committed to providing rapid, actionable results and unmatched user-friendliness to meet the needs of clinical laboratories and health care providers worldwide."

Now, Blood Test Can Detect Bacteria/Virus Causing Septicemia in Seven Hours


Now, a blood test can detect the exact bacteria or virus that has caused septicemia — the most common life threatening blood infection — in a patient.

What's even better, the test will take only seven hours instead of four days at present.

The same test will also be able to tell doctors which antibiotics the organism is resistant to, saving precious time and increasing the patient's chances of survival. Scientists from the Centre for Cellular and Molecular Biology (CCMB) in Hyderabad have discovered a DNA-based diagnostic tool that can identify all 27 organisms that causes septicemia — an infection that leads to a dangerous build-up of bacteria in bloodstream.

Septicemia that progresses to septic shock has a death rate as high as 50%, depending on the type of organism involved.

CCMB director Mohan Rao said the Centre has transferred the technology to a private medical devices company to produce the diagnostic tool.

Rao said the project to develop the rapid diagnostic tool for septicemia was part of CSIR's New Millennium Technology Leadership Initiative. The CCMB team has been working on developing this tool for over three years.

"It is of vital importance to know which organism has actually caused septicemia in the patient so that the appropriate drugs can be administered. Till now, detecting the bacteria or virus took a long time as one needed to conduct a culture test. The new diagnostic tool has two different chips — one can detect the causative organism of septicemia in just seven hours instead of days and the other can gauge which drugs the organism is resistant to. At present the diagnostic chip is made of plastic. We are working on creating a similar paper based microfluidic chip," Dr Rao said.

Dr Rao added, "The tool can detect all known bacteria or viruses known to cause septicemia and are expected to be available in the market soon. We recently transferred the technology to a diagnostics company in Bangalore. The test is expected to cost around Rs 10,000. However, the price is expected to dip once advances are made to the tool."

The most common areas of infection that lead to septicemia include the abdomen, lungs, urinary tract, bone (osteomyelitis), central nervous system (meningitis) and heart (endocarditis).

With septicemia, the initial symptoms include accelerated pulse, rapid breathing, chills and high fevers that come on suddenly. These may lead to shock and a sudden decrease in blood pressure, and confusion or other mental changes.

Red spots may occur on the skin as a result of clotting problems in the blood.

Treatment of septicemia requires hospitalization, where intravenous fluids and antibiotics are given, along with supplemental oxygen.

Dairy/Milk Testing Instruments Measure Bacterial Levels


MOCON, Inc. is now making its new GreenLight® instrumentation available for dairy applications. The breakthrough oxygen-depleting technology for measuring aerobic bacterial levels can provide results for raw milk between 30 minutes and five hours. This compares to 48- to 72-hours required by the traditional, agar-based, standard plate count method.

The GreenLight® series was developed to deliver fast and precise bacterial load results in a cost-effective manner. Although other technologies exist which also offer fast results, their high cost-of-entry makes them cost-prohibitive for most companies.

GreenLight® instruments are ideal for anyone involved in raw milk testing including dairies, cooperatives, laboratories and farmers. They also provide valuable information for downstream processing, such as cheese making, when milk is a primary component.

"Raw milk testing is a time consuming processes that removes resources from other value-adding activities. GreenLight's speed, simplicity, precision and low-cost entry is an ideal productivity-enhancing tool," said Alan Traylor, business manager, food safety products, MOCON.

To conduct the test, the milk sample is simply poured into a bar-coded APCheck(TM) vial, which has built-in sensor material. Raw milk has sufficient nutrients so that added buffers/reagents or dilutions are not required before testing, unlike traditional testing methods which require three dilutions.

When the company's fully automated GreenLight® 930 is used, the vials can be batch loaded onto the 48-position carousel, or individually loaded at any time during the unit's "continuous" mode. As bacteria in the test sample multiply and respire, they consume oxygen. The change in oxygen is used to calculate the milk's colony forming units per milliliter. (Bacterial load is calculated in the PC and stored to a secure data base.)

There is also a smaller, more compact GreenLight® 910 which makes it easier for dairy farmers to use closer to the milk source.

"Since raw milk producers are compensated based on the bacterial level, it's important to be able to produce precise and fast results prior to pooling and/or transport. GreenLight® can make that happen in an affordable manner," Traylor said.

MOCON is now making the rapid GreenLight® assay with its dedicated reader available across the globe. The objective is to help improve dairy hygiene and assist farmers in obtaining the best price for their milk.

Luminex Corporation and University Hospital of Wales Collaborate During Olympic Games


Luminex Corporation announced that Public Health Wales is using Luminex's CE marked xTAG Gastrointestinal Pathogen Panel (GPP) for outbreak investigation activities during Olympic and Paralympic training and events taking place in Wales. Results of a substantial diagnostic validation of the GPP test conducted by The Public Health Wales Microbiology laboratory team at the University Hospital of Wales, Cardiff, are anticipated to be published in a peer reviewed journal.

Luminex's xTAG GPP received CE mark in 2011 and is the most comprehensive test available to diagnose gastrointestinal infections. xTAG GPP simultaneously detects fifteen of the most common disease-causing pathogens, including viral, bacterial and parasitic infections, such as norovirus, C. difficile, toxigenic strains of E. coli, Campylobacter, Cryptosporidium, and Salmonella, all within 5-6 hours. Innovations in diagnostic technology like xTAG GPP provide the potential for rapid identification of the cause of outbreaks of gastrointestinal infection and improved patient care.

"We are very pleased with the performance of the assay to date in our validations comparing it to our traditional methods," said Michael Perry, Clinical Scientist within the National Molecular Diagnostics Laboratory, Public Health Wales. "The ability to generate answers during a single work shift for a majority of the pathogens involved in gastroenteritis, compared to traditional methods which would have taken 2 days in some cases and much more work to return the same amount of information, is a significant advance."

"Seeing the contribution of our technology innovations and ability to make a positive impact in public health makes us very proud," said Patrick J. Balthrop, president and CEO of Luminex. "We are pleased to work with thought leaders like the Molecular Laboratory team at Public Health Wales, Cardiff, who continue to advance healthcare and public safety."

About xTAG Gastrointestinal Pathogen Panel (GPP)

xTAG GPP is a qualitative molecular multiplex diarrhea test intended for the simultaneous detection and identification of multiple gastrointestinal pathogens including bacteria, viruses, and parasites. The assay uses the proprietary Luminex xTAG Technology and the xMAP® Technology platform to detect multiple targets in a single sample. xTAG GPP can detect Hospital Acquired Infections (HAI) such as C. difficile or norovirus, foodborne illness agents like E. coli or Salmonella and common pediatric diarrhea causatives such as Rotavirus.

Wednesday, August 1, 2012

Micro Imaging Technology Introduces the MIT 1000 to Food Safety Industry Professionals


Micro Imaging Technology, Inc. announced that an important segment of the food safety community got its first look at its Rapid Microbial Identification System when it introduced the MIT 1000 at the Annual Meeting of the International Association for Food Protection (IAFP) in Providence, Rhode Island held July 22 through July 25, 2012.

"We could not have been more pleased with the reception that the MIT 1000 received at the conference," stated Jeff Nunez, MIT's Chairman and CEO, "and we expect our time and efforts to be well rewarded judging by the amount of interest and excitement our technology generated from potential users, consultants, professors, Universities, and competitors." Known to be the leading food safety conference worldwide each year, the IAFP is attended by more than 2,500 of the top industry, academic and governmental food safety professionals from around the world.

The MIT 1000 is a stand-alone, rapid laser based bacteria detection and identification technology; a software driven system that can detect pathogenic bacteria and complete an identifying test in less than five (5) minutes for pennies per test. In June 2009, the AOAC Research Institute (AOAC RI) awarded the Company Performance Tested Methods SM (PTM) certification for the rapid identification of Listeria. The AOAC RI provides an independent third party evaluation and expert reviews of methods and will award PTM certification to methods that demonstrate performance levels equivalent or better than other certified bacteria identifying methods. The MIT System underwent hundreds of individual tests, including ruggedness and accuracy, to earn AOAC RI's certification for the identification of Listeria.

"With the number of food-related illnesses and deaths on the rise each year, particularly involving Listeria, Listeria monocytogenes, Salmonella and E. coli, our technology and its rapid diagnostics could mean the difference between life and death," suggested MIT's Chief Scientist, David Haavig, PhD. "I was gratified to find that the goal of the IAFP conference was not to promote one technology over another, but to advance food safety overall. That's what the MIT 1000 will do and that's why it was good for us to be at this conference."

QIAGEN Automated Workflow with QIAsymphony RGQ receives AOAC Validation for Detection of Salmonella


QIAGEN announced that its mericon[R] Salmonella spp. kit in combination with the QIAsymphony RGQ automation platform has received validation from the AOAC Research Institute, an independent third party organization that evaluates analytical methods for use in food safety and other testing. The mericon[R] kit provides all necessary reagents for detection of Salmonella subspecies (or spp.) and runs on the QIAsymphony RGQ modular system, which automates entire workflows from food sample to the final result. The AOAC Research Institute validated the mericon[R] kit on QIAsymphony RGQ, as well as manual use, for low- and high-throughput testing of eight different food sample types. QIAGEN is exhibiting its technologies, including the Salmonella workflow, this week at the annual meeting of the International Association for Food Protection (IAFP) in Providence, Rhode Island.

"Achieving this validation of our QIAsymphony RGQ automated workflow in finding Salmonella, the most significant market opportunity in safeguarding food safety, adds further momentum to the dissemination of our instruments and test kits in the Applied Testing market. Our emerging food safety testing portfolio is very rapidly growing," said Dr. Dietrich Hauffe, Senior Vice President, Life Sciences Business Area, of QIAGEN. "As a result of this key certification, food industry labs can now process more samples and improve efficiency by automating their Salmonella workflow using our mericon[R] Salmonella spp. kit with QIAsymphony RGQ. This certification marks an important milestone, as further key assays in our broad food testing assay portfolio are targeting certification and a growing number of labs are adopting the QIAsymphony RGQ platform."

Sharon Brunelle, technical consultant for the AOAC Research Institute, said in a statement that QIAGEN "has demonstrated that the mericon workflow performs as well or better than the ISO reference method for selected foods, earning Performance Tested Method certification." AOAC Research Institute is a wholly owned subsidiary of AOAC INTERNATIONAL (AOAC), an international standards developing organization with a membership of more than 3,000 laboratory scientists and officials. The AOAC Performance Tested[SM] certification has international recognition.

Salmonella is a common bacterium in nature that can cause serious illness when ingested in contaminated food, drink or water. More than 1 million people a year in the United States suffer gastrointestinal sickness from Salmonella, which normally goes away after a few days but can be dangerous to elderly or vulnerable patients, according to the Food and Drug Administration. One type of Salmonella causes typhoid fever, a life-threatening infection that can produce high fevers and damage to vital organs or joints. Left untreated, about one in 10 patients with the typhoidal infection will die. The FDA estimates 1,800 people a year in the U.S. contract typhoid fever.

QIAGEN offers a range of innovative, high-quality solutions to help safeguard the food supply and continues to add content to address various threats to public health. QIAGEN's suite of food safety test kits covers all phases of testing for this global market, including DNA purification, screening for pathogens, genetically modified organism (GMO) detection, and ingredient authentication.

Diving Board Sensors Key to DNA Detection


A tiny vibrating cantilever sensor could soon help doctors and field clinicians quickly detect harmful toxins, bacteria and even indicators of certain types of cancer from small samples of blood or urine. Researchers from Drexel University are in the process of refining a sensor technology that they developed to measure samples at the cellular level into an accurate method for quickly detecting traces of DNA in liquid samples.

According to lead researcher Dr. Raj Mutharasan, a professor in Drexel's College of Engineering, the group's unique application of lead zirconate titanate (PZT) to current piezoelectric-excited cantilever sensor technology has created a way to conduct more sensitive and timely tests for DNA. This DNA test will allow for quick identification of harmful cells and bacteria.

"I equate this new technology to authorities trying to catch a criminal using latent fingerprints rather than a mug shot," Mutharasan said. "It is more precise, selective and sensitive. With the PZT sensor we can potentially detect DNA derived from a much smaller number of pathogens and in a much shorter period of time than current methods."

Cantilever Sensor Uses Electric Current for More Sensitive Measurements Cantilever sensor technology, which has been around for a little over a decade, detects its minute targets using a method that is relatable to a springboard bouncing with the movements of a diver. The "board" –or cantilever in this application– vibrates at a higher frequency when the diver jumps off and his or her mass is removed. Conversely, the vibration frequency of a cantilever would decrease when weight is added to it. Measuring the difference in frequency of mass-free versus mass-loaded vibrations allow researchers to detect cells or, in this case, DNA, in samples.

Mutharasan and his group combined the PZT material to the cantilever in an innovative design, which allows researchers to initiate the "springboard" effect by applying an electric current. This is an upgrade over the classical cantilever method which requires an external stimulus –a flick of the diving board– to set the system into motion.

Because PZT sensors are completely controllable, Mutharasan's group has discovered high-order vibration modes in certain designs that are sensitive to very small mass changes, on the order of one-billionth of a microgram, in liquid samples.

"Such high sensitivity enables us to measure biological molecules at a million-fold more sensitive than what is currently feasible," Mutharasan said.

A Second Advantage: Rapid Room-Temperature Replication of DNA

The PZT cantilever device is dually useful because it speeds up the process of replicating DNA in a sample. Replication is a necessary step in the testing process in order to improve the quality of the sample and positively identify the bacteria or cell of its origin, much like growing bacterial culture. Muthrasan's research group will conduct simultaneous amplification and detection of DNA that is expected to be carried out at room temperature and in a short time frame.

Typical replication can be time-consuming because the sample needs to be heated in order to begin the process. The advantage of the cantilever sensor is that double-stranded DNA can be unwound by vibrating the sensor at the proper frequency. This procedure essential step for replication can cut a typical detection process, which could take several hours, down to less than an hour.

The National Science Foundation recently awarded the team a grant to continue research into simultaneous DNA replication and detection using these piezoelectric vibrations. The key discovery that Mutharasan's team is building upon is its observation that DNA can be "melted" –a term describing the process of unwinding a DNA strand for replication– by application of mechanical energy to sensor surface via PZT.

With the PZT sensor's unique ability to test samples in liquids and at room temperature, Mutharasan can foresee applications in detecting food and water contamination, as well as use in the medical field. In early testing the PZT sensor has successfully detected DNA indicators for prostate cancer in urine samples, toxin-producing genes in pathogenic E. coli and an identifying gene of malaria-causing Plasmodium falciparum in patient blood samples. The technology is still likely to be three-to-five years from becoming commercially available for medical and environmental uses, according to Mutharasan.

Roka Bioscience Kicks off Atlas on Tour, a Mobile Demonstration Vehicle for the Food Safety Industry, at IAFP


Roka Bioscience introduced the Atlas on Tour vehicle at the 2012 International Association for Food Protection (IAFP) Meeting in Providence, Rhode Island. The custom-built 40-foot vehicle features a working Atlas System and provides an informational forum for food safety laboratories. The vehicle offers food safety professionals the opportunity to experience a full demonstration of the Atlas System, as well as interactive presentations on the technologies that power the system. The vehicle also contains a conference area where participants can discuss their specific testing needs with Roka Applications Specialists.

"The IAFP Meeting was the ideal location for introducing our Atlas on Tour vehicle to the Food Safety Industry and launching the tour," explained Paul Thomas, CEO and President of Roka Bioscience. "The tour gives our customers rare, direct access to a system that can revolutionize their laboratory testing. This type of innovation has to be shared, and we are thrilled to do so in such a personal and accessible way."

IAFP marks the first public stop for the Atlas on Tour vehicle. From there, the tour will take Roka and its Atlas System to industry, government, and academic sites, and trade shows across the United States. Roka's Atlas on Tour website www.atlasontour.com provides users with more details on the tour, the vehicle, and the Atlas System, as well as information on scheduling a visit at their location.

The Atlas System is an innovative fully automated molecular instrument for the detection of pathogens in food and environmental samples. This instrument utilizes a simple three-step procedure -- Enrich, Transfer, Automate -- and is capable of processing over 300 samples in 8 hours. The system's continuous workflow and high throughput provides greater efficiency, flexibility, and dynamic scalability to meet the ever-increasing demands placed on food safety laboratories. Customer evaluations have demonstrated a reduction in direct labor costs with the Atlas System in side-by-side comparisons with leading competitive methods.

The initial menu for the Atlas System includes the Atlas Salmonella Detection Assay and the Atlas Listeria Detection Assay, both of which are AOAC-RI certified. Additional assays are currently in development.

NanoLogix Featured in USA Today Group B Streptococcus (GBS) Awareness Campaign


NanoLogix, a biotechnology innovator in the rapid detection and identification of live-threat bacteria, is featured today in the USA Today Group B Strep (GBS) Awareness Campaign titled Your guide to Group B Strep. The campaign featured in the USA Today News Section promotes public education on the dangers of GBS in newborns and highlights the latest testing methods to help prevent the disease. Research using NanoLogix BNF technology, from the University of Texas Health Science Center in Houston (UTHSC), is featured in the campaign. While GBS culturing methods typically take 48 hours of incubation to obtain results, this research from UTHSC documents that NanoLogix technology can detect, identify and provide antibiotic sensitivity results for GBS in as little as four hours, four times faster than conventional methods.

"It's an honor to be included in this GBS awareness campaign," said NanoLogix CEO Bret Barnhizer. "The strong readership of USA Today is a tremendous opportunity to help pregnant women understand the dangers of Group B Strep and the critical importance early testing plays in the health of their newborns. We look forward to our rapid tests supporting the protection of many newborns and mothers from this life-threatening disease, both in the US and abroad."

According to Dr. James A. McGregor, M.D.C.M of Group B Strep International, "Untreated, Group B Streptococcus (GBS) infection is the most common germ-related killer of newborn babies. More accurate, rapid result tests for GBS can target use of antibiotic at birth with possible reduction of resistance to antibiotics and help avoid unnecessary disturbance of the healthy, protective bacteria inside mother and baby. Parents appreciate doctors keeping Group B Strep in mind to reduce possible infections before, during, and after pregnancy. Accurate rapid testing when labor starts or water breaks can help maximize protection from GBS infection for babies at birth."

Marti Perhach, CEO/Cofounder of Group B Strep International stated, "I first contacted NanoLogix about a year ago when I heard they were developing a new rapid test to detect Group B Strep. Having an accurate rapid test available is extremely important, especially as women may test negative during routine screening, but be positive during labor and delivery. Group B Strep International's mission is to promote awareness and prevention of Group B Strep disease in all babies throughout pregnancy and early infancy. As sponsors of July as International Group B Strep Awareness Month, we invited Nanologix to participate in our awareness campaign. We are so appreciative of their efforts in GBS awareness and the excellent information they have made available to the general public through USAToday.com." For further information on Group B Strep awareness and prevention, please visit www.groupbstrepinternational.org.

If Group B Strep-colonized mothers give birth before antibiotics can be administered, the bacteria can be passed to the newborn, causing life-threatening infections, such as meningitis and sepsis. According to the CDC, about 25 percent of women test positive for Group B Strep and on average 1,200 American newborns less than a week old contract the disease.

The 7-day campaign featured on USA Today.com will run until Monday August 6th. Also included in the GBS Awareness campaign are the Centers for Disease Control and Prevention (CDC), the Keck School of Medicine at the University of Southern California, the Center for Vaccine Awareness & Research, and the Group B Strep Association.

NanoLogix is a biotechnology company focused primarily on rapid diagnostics. Its products offer accelerated detection and identification of microorganisms. In addition to medical and homeland security applications, NanoLogix technology is applicable in pharmaceutical, industrial, veterinary and environmental testing. Patents granted to NanoLogix can be used in the areas of applied microbiology, soil microbiology and bioremediation, microbial physiology, molecular biology, pharmacology, pharmaco-kinetics, and antibiotic sensitivity.