Sunday, July 29, 2012

PositiveID Corporation Adds Chief Technology Advisor and Biodefense Expert as It Prepares for $3.1 Billion BioWatch Procurement

PositiveID Corporation, an emerging growth company and developer of sophisticated airborne bio-threat detection systems for America's homeland defense, today announced it has added Dr. Kimothy Smith as Chief Technology Advisor to the Company and its Microfluidic Systems ("MFS") subsidiary. The Company will utilize Dr. Smith's expertise in the areas of biosurveillance, biodefense, biosecurity, molecular genetics and diagnostics, as it prepares for the release of the final request for proposal from the Department of Homeland Security ("DHS") for BioWatch Generation 3, a $3.1 billion procurement for an early warning system designed to detect the intentional release of airborne biological agents. The Company believes its M-BAND system is one of the only technologies capable of addressing the requirements of BioWatch Generation 3.

Dr. Smith has served as a Senior Advisor for International Biodefense for DHS' Office of Health Affairs and was detailed to the U.S. State Department Office of International Health and Biodefense. Prior to this he served as the Acting Director of the National Biosurveillance Integration Center, where he set the vision and strategy of a U.S. government-wide effort to acquire, aggregate, integrate, analyze, interpret and disseminate all-source biosurveillance information from governmental and private sectors for epidemiological analyses and health protection.

Recently Dr. Smith was as a Senior Scientist for the Tahoe Research Initiative LLC, where he worked on global biosurveillance issues to build capacity and capability of public and veterinary health systems. Moreover, he was the Department of Homeland Security's first Chief Veterinarian and served as the Chief Scientist for the Office of Health Affairs. Prior to working with DHS, Dr. Smith worked at Lawrence Livermore National Laboratory LLNL, where he served as the Deputy Division Leader for Operations in the Counter-terrorism and Incident Response Division of the Non-proliferation, Arms Control and International Security Directorate. In this capacity Dr. Smith was responsible for maintenance and readiness of the laboratory's nuclear response deployment and assessment teams. He earned his Ph.D. in molecular epidemiology from Louisiana State University (1999) where he curated the worldwide Bacillus anthracis collection.

William J. Caragol, Chairman and CEO of PositiveID, said, "We believe that Kimothy's deep knowledge and experience in bioterrorism and biodefense strengthens our team as we move toward this important program."

Harper Government Teams With Canadian Researchers to Bolster Food Safety System

The Canadian Food Inspection Agency, Genome Canada and Alberta Innovates Bio Solutions are partnering in a $600,000 project that will help protect consumers from Listeriosis, a serious foodborne illness.

The project aims to map the genome of Listeria bacteria so that more rapid tests can be developed. Current test methods take at least five days. Genomic techniques could improve accuracy and cut testing time significantly, allowing the CFIA and industry to more effectively identify unsafe foods.

"The Harper Government is committed to improving Canada's already robust food safety system," said Agriculture Minister, Gerry Ritz. "Through investments in science and innovation, we are giving industry the opportunity to better identify and reduce risks for consumers, meaning safer food for Canadian families."

Gary Goodyear, Minister of State for Science and Technology, said: "This project is a step the Harper Government is taking to demonstrate how Canada's research leadership can be used to benefit Canadian society by investigating innovative and more timely techniques to protect our food supply."

Listeriosis is a serious concern for the food industry. Although healthy people are not often affected, the elderly, pregnant women and children especially can suffer serious complications.

In general, Listeria monocytogenes appears to be capable of survival regardless of freezing, dehydration and exposure to temperature regimes commonly used in the pasteurization of food. Given the seriousness of this bacterium as a food pathogen, its timely detection in food will help reduce the incidence of foodborne listeriosis.

Pierre Meulien, President and CEO, Genome Canada, said: "Genomics research will bring a new level of advanced innovation and technology to food safety. We expect to provide the means to enable both the food industry and food regulators to respond swiftly to food safety investigations by identifying a potentially dangerous food contaminant as quickly as possible to prevent or limit the impact of an outbreak."

Stan Blade, CEO, Alberta Innovates Bio Solutions, said: "While Canada and Alberta have an excellent reputation for food safety, we strive for continuous improvements through the application of science and innovation. We are pleased to support a program that will further our knowledge about Listeria and enhance Canada's reputation as a preferred supplier of safe food products."

The 18-month research project involves an investment of $250,000 each from Genome Canada and the Canadian Food Inspection Agency, and $100,000 from Alberta Innovates Bio Solutions. Through the Request for Applications, released today, participants have until October to submit proposals for funding.

Genome Canada is a catalyst for developing and applying genomic sciences that create economic wealth and social benefit for Canadians. We work in partnership to invest in and manage large-scale research and translate discoveries into commercial opportunities, new technologies, applications and solutions. We build bridges between government, academia and industry to forge a genomics-based public-private innovation focused on key life science sectors.

The Canadian Food Inspection Agency (CFIA) is Canada's largest science-based regulator. The Agency is dedicated to safeguarding food, animals and plants, which enhances the health and well-being of Canada's people, environment and economy.

Alberta Innovates Bio Solutions (AI Bio) is a publicly funded board-governed corporation that works with partners to identify, coordinate and fund research projects designed to help solve industry challenges with solutions that deliver economic, environmental and social benefits. Through this investment in science and innovation, AI Bio aims to help create new technologies and products that will grow Alberta's agriculture, food and forest sectors.

New Pall GeneDisc® System For Rapid Microbiological Monitoring Solution In Beer Production

Pall Corporation announced that it has launched a quick, easy and affordable test for beer-spoilage microorganisms based on its GeneDisc® Rapid Microbiology System

Utilizing real-time Polymerase Chain Reaction (PCR) technology, Pall’s GeneDisc test provides a fast, reliable and user-friendly detection method to identify typical bacteria that are known to spoil beer. The system yields consistently repeatable results and virtually eliminates operator error. Test results from a beer sample are available after enrichment and DNA isolation within one hour.

"For the first time, the benefits of PCR technology are available to brewers for routine, day-to-day use,” said Jonathan Pratt, president, Pall Food and Beverage. “The new GeneDisc system offers breweries an extremely easy-to-use and rapid test method to better ensure that products at every stage of the production process are free of spoilage organisms."

The Pall GeneDisc system features an exceptionally robust PCR platform combined with ready-to-use GeneDisc test plates. Using the GeneDisc plate for beer-spoilage bacteria, the system simultaneously screens for the presence or absence of 20 critical beer-spoilage bacteria, including the relevant species of Lactobacillus, Megasphaera, Pediococcus and Pectinatus sp. beer-spoilage groups.

With its intuitive touch-screen interface, built-in software and barcode reader, the system enables minimally trained personnel to routinely perform sophisticated biological sample testing for rapid decision-making. The flexible GeneDisc system also helps optimize work flow and offers the capability to process multiple samples simultaneously.

Learn more about the GeneDisc Rapid Microbiology System and the Beer Spoilage Plate at the World Brewing Congress, an international gathering of brewing industry professionals, July 28-31, 2012 in Portland, Oregon, booth # 855.

Monday, July 23, 2012

Life Technologies Develops Simplified SAME-DAY STEC Solution for Detecting Multiple Strains of E. coli in Ground Beef

Life Technologies Corporation announced today that it has developed a complete rapid molecular testing workflow for multiple strains of pathogenic Shiga-toxin producing Escherichia coli (STEC), a bacteria found in undercooked beef.

Meat producers require a faster and simpler method to accurately detect multiple STEC strains, which can include the well-known O157:H7 serotype as well as more than 100 non-O157 strains. The U.S. Department of Agriculture (USDA) now requires testing for the "Big Six" non-O157 strains (O26, O45, O103, O111, O121 and O145) that cause about 70 percent of non-O157 infection, but this testing requires new analytical methods.

The USDA Microbiology Laboratory Guidebook (MLG) method is the formal approach recommended by the USDA's Food Safety and Inspection Service (FSIS) for the testing and isolation of the "Big 6" STECs in ground beef and beef trim in the U.S. Life Technologies offers many of the reagents validated in the USDA FSIS MLG method.

While the MLG method provides confident results and isolation of the pathogen, the six -day process is too long, requires too many reagents, and requires significant technician training and processing, all of which drives up the cost.

Life Technologies has been collaborating with the USDA Agricultural Research Service (ARS) to validate assay designs against an extensive panel of both pathogenic and non-pathogenic STECs of various o- group and origin. The result is highly-specific, single-target PCR assays which can be multiplexed to provide high levels of accuracy for a high-throughput screening assay.

The Life Technologies workflow will provide faster, simpler detection with the same level of sensitivity and accuracy produced by the MLG method:

- Compatible with your existing testing program and simultaneously detects E. coli O157:H7 and the "Big 6" non-O157 E. coli in 375g of ground beef and beef trim samples.
- Detects as little as 1 to 5cfu of pathogenic STEC in your sample, with proprietary assay designs that lower chances for false positives and eliminate false negatives.
- Same day detection of pathogenic STECs. Clearance of 375g of ground beef and beef trim samples in as little as 10 hours.

"The more strains of E. coli that meat producers can quickly and accurately analyze, the more likely they can ensure that beef is safe for public consumption, and poses no threat of illnesses caused by foodborne bacterium," said Nir Nimrodi, Vice President and General Manager of Food Safety and Animal Health at Life Technologies.

Sunday, July 22, 2012

Idaho Technology Initiates Clinical Study for FilmArray® Blood Culture Identification (BCID) Panel

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 announced it has commenced a clinical trial to evaluate the Company's FilmArray Blood Culture Identification (BCID) Panel, which is designed to identify the numerous organisms that can cause sepsis, as well as detect the presence of selected antibiotic resistance genes. The study is being conducted at several hospital-based clinical laboratories in the U.S. The FilmArray BCID will be the second clinical diagnostic test to run on Idaho Technology's FilmArray pathogen detection system.

Kirk Ririe, Chief Executive Officer of Idaho Technology, states, "Initiating clinical studies for our BCID panel brings us another step closer to being able to provide more comprehensive, actionable information which may help guide treatment decisions and improve patient outcomes. It also marks an important milestone in the expansion of our FilmArray clinical diagnostic test menu. Many of our existing FilmArray customers have expressed strong interest in using our BCID panel, based on the streamlined workflow and rapid results offered by our system. We believe the additional menu offering will accelerate adoption and utilization of FilmArray in global markets."

Idaho Technology anticipates the trial will run through the end of 2012 and expects to submit a 510(k) to the Food & Drug Administration (FDA) in early 2013. Pending FDA clearance, the Company intends to launch FilmArray BCID commercially in the U.S. in the second quarter of 2013. The BCID panel will also be CE IVD-marked and offered for sale in the European Union in early 2013.

In parallel with the clinical study, Idaho Technology plans to offer select clinical laboratories limited access to FilmArray BCID as part of an investigational use only (IUO) program. The purpose of this program is to familiarize current FilmArray users with the investigational BCID panel.

About FilmArray BCID

FilmArray BCID is designed to provide hospital laboratories with a simple, more rapid system for identifying infectious microbes immediately following positive blood culture results. It provides 27 different tests for Gram-positive bacteria, Gram-negative bacteria, and fungal pathogens, the majority of which are identified at the species level. It is designed to correctly identify approximately 90% of all microbes commonly found in positive aerobic blood cultures. FilmArray BCID also detects the presence of certain antibiotic resistance genes. Rapid identification of a large range of pathogens in blood culture could improve the medical management of sepsis.

About Idaho Technology, Inc.

Idaho Technology, Inc. is a privately held clinical diagnostics company based in Salt Lake City, Utah. Founded in 1990, the Company currently holds over 70 patents related to polymerase chain reaction (PCR), including rapid PCR cycling. The Company has used its extensive patent portfolio to successfully market nearly 200 products to the clinical, research and military markets. The Company manufactures and distributes its proprietary diagnostic respiratory panel, FilmArray RP, which operates on its user-friendly FilmArray system, to hospital-based clinical laboratories in the U.S. and E.U. The Company also collaborates with various U.S. governmental agencies including the Department of Health and Human Services, and the Department of Defense. Among others, researchers, medical technicians, law enforcement officers, and soldiers in the field use company devices to detect or study disease-causing organisms.

Lakewood Ranch-based Rapid Pathogen Screening Sees Growth Opportunities

A company that has spent the past eight years developing a disposable diagnostic test for pink eye and other inflammatory diseases is now commercializing the product.

Rapid Pathogen Screening Inc. has signed a licensing agreement with a French development firm to market its patented test kits to optometrists, ophthalmologists and family physicians across the U.S. and in Europe.

The AdenoPlus kit allows clinicians to diagnose the highly contagious viral form of conjunctivitis, or pink-eye, within minutes during a medical office visit. Previously, health care technicians could only confirm pink eye with a culture swab or DNA test, expensive methods that took several hours or days.

The Lakewood Ranch firm also is working with the U.S. Department of Homeland Security on refining the technology for use in helping rapidly diagnose large groups of people in the event of a biological attack. As a result, RPS expects to add jobs and expand its facility.

"We're at the launching point, so to speak, of rapid growth and expansion of the company itself," said Dr. Robert Sambursky, RPS president, chairman and CEO. "Over the years, we foresee a significant amount of new hiring and expansions at our facility. I don't know exact numbers because it changes day to day."

The company develops point-of-care diagnostic tests that can be used to spot just about any virus or bacterial infection within minutes. The technology also can be implemented through various platforms with tests for urine, blood or any other bodily liquid. The initial RPS product was designed as a faster alternative to lab testing for pink eye, a highly contagious disease that results in some chronic damage for 30 percent of patients, Sambursky said.

A second version of the product -- AdenoPlus -- was released last year, making the test faster and easier to use.

Sambursky believes the technology will become a staple in health care, ensuring clinicians prescribe the correct medications and keeping patients from classrooms and office buildings where the virus can quickly spread.

Because pink eye has a vast overlap in signs and symptoms, it's historically difficult to catch early, Sambursky said.

RPS plans to mold the platform to fit other sectors that are under-served, or where on-spot viral testing is lax.

"This technology will improve medical care and bring costs down," Sambursky said. "We're not limited to what we can test for."

The company has also signed a contract with the Department of Homeland Security's Chemical and Biological Defense Division to develop a rapid test for emergency pandemic situations.

The test will use a finger stick of blood to quickly identify whether a person has a viral or bacterial infection, helping the government better respond with the appropriate treatment.

That product is still in the development stages, and company officials wouldn't elaborate much on the details of the contract or give a timetable for its roll out.

"It's basically intended to provide diagnoses in situations where we're trying to differentiate a viral infection from a bacteria infection with a finger stick of blood," said Marketing Manager Laura Lovejoy. "It can provide diagnoses should a biological attack occur."

Researchers Develop Rapid Diagnostic Test for Pathogens, Contaminants

Using nanoscale materials, researchers at the University of Georgia have developed a single-step method to rapidly and accurately detect viruses, bacteria and chemical contaminants. In a series of studies, the scientists were able to detect compounds such as lactic acid and the protein albumin in highly diluted samples and in mixtures that included dyes and other chemicals. Their results suggest that the same system could be used to detect pathogens and contaminants in biological mixtures such as food, blood, saliva and urine.

"The results are unambiguous and quickly give you a high degree of specificity," said senior author Yiping Zhao, professor of physics in the UGA Franklin College of Arts and Sciences and director of the university's Nanoscale Science and Engineering Center.

Zhao and his co-authors—doctoral students Jing Chen and Justin Abell and professor Yao-wen Huang of the UGA College of Agricultural and Environmental Sciences—used nanotechnology to combine two well-known techniques and create their new diagnostic test. Their results appear in the early online edition of the journal Lab on a Chip and were recently presented at the SPIE Defense, Security and Sensing conference.

The first component of their two-in-one system uses a technique known as surface enhanced Raman spectroscopy, or SERS, which measures the change in frequency of a laser as it scatters off a compound. Every compound displays a series of distinctive changes in frequency, or Raman shifts, that are as unique as a fingerprint. The signal produced by Raman scattering is inherently weak, but Zhao and his colleagues have arrayed silver nanorods 1,000 times finer than the width of a human hair at a precise angle to significantly amplify the signal. In previous studies with Ralph Tripp in the UGA College of Veterinary Medicine and chemist Richard Dluhy in the Franklin College, they demonstrated that the use of SERS with silver nanorods could identify viruses such as HIV and RSV isolated from infected cells.

"In a clinical setting, the sample that you obtain from patients typically contains bacteria or viruses as well as a lot of fluid—as in blood, urine or saliva—that contains biological agents that interfere with the signal you're trying to detect," Zhao said. "To develop a diagnostic that could be used at the point of care, we needed a way to separate those agents."

Once again, the scientists turned to nanotechnology to create a next-generation diagnostic test. Using traditional thin layer chromatography, or TLC, scientists blot a drop of sample onto a porous surface. They then apply a solvent such as methanol to the sample, and the sample components separate based on how strongly they're attracted to the solvent and the surface.

Study co-author Justin Abell, a doctoral student in the UGA College of Engineering, explained that TLC typically requires a large sample volume because the compound of interest soaks into the surface in addition to moving along it, like a stain on a rug. The silver nanorod surface that the researchers use, in contrast, allows them to use a miniscule amount of sample in a technique known as ultra-thin layer chromatography.

"In our case, the nanorods are acting as the detection medium but also as the separation medium," Abell said, "so it's a two-in-one system."

To test their method, the researchers used mixtures of dyes, the organic chemical melamine, lactic acid and the protein albumin. In each case, they were able to directly identify the compounds of interest, even in samples diluted to concentrations below 182 nanograms per milliliter—roughly 200 billionths of a gram in a fifth of a teaspoon. And while the detection of viruses using techniques such as polymerase chain reaction can take days or even weeks and requires fluorescent labels, the on-chip method developed by the UGA researchers yields results in less than an hour without the use of molecular labels.

The researchers are currently testing their technique with biological samples from Tripp's lab that contain viruses, and Zhao said preliminary results are promising. He adds that while his team is focused on health and food safety applications, SERS and ultra-thin layer chromatography can be used to detect compounds of all types—everything from forensic materials at a crime scene to environmental pollutants. His team also is working with colleagues across campus to create an online encyclopedia that would allow technicians to identify viruses, bacteria, biomarkers and pharmaceuticals based on their distinctive Raman shifts. "Every compound has a unique SERS spectrum," Zhao said, "so this is a very robust technology whose applications are practically endless."

IMDx Obtains CE-Marking for an Automated Molecular Test for Detection and Differentiation of Herpes Simplex Viruses 1 and 2

IntelligentMDx (IMDx) announced today that it has obtained CE-marking for its fourth automated, high-throughput molecular test designed and developed for the Abbott m2000 System. The IMDx HSV-1/2 for Abbott m2000 detects Herpes Simplex Virus (HSV) viral DNA and differentiates HSV-1 and HSV-2 in male and female genital or oral lesions and cerebral spinal fluid (CSF).

HSV is the most common cause of genital and oral lesions, but can also invade other human tissue, occasionally causing keratitis, encephalitis, meningitis, and neonatal sepsis. Globally, an estimated 4.0 billion people are currently infected with HSV and the worldwide incidence of HSV-1 infection is considered the second largest, surpassed only by incidences of the common cold.

"We are proud to play a role in easing the global burden of herpes virus infections through rapid and precise diagnostics." Says Dr. Alice Jacobs, MD, Chairman & CEO of IntelligentMDx. "Automated, high-throughput molecular diagnostics are becoming the method of choice for fast and reliable diagnosis of infections. The robust performance and automated nature of the IMDx HSV-1/2 for Abbott m2000 assay can aid in the diagnosis of patients and support faster treatment decisions."

The IMDx HSV-1/2 for Abbott m2000 assay offers a fully automated method for accurate testing of up to 94 patient samples simultaneously in less than 6 hours. Minimal hands-on time is required as results are obtained using a direct swab taken from a symptomatic male or female patient. When compared against clinical samples classified for HSV-1 and HSV-2 using culture and a molecular reference method, the IMDx HSV-1/2 for Abbott m2000 demonstrated 100.0% sensitivity and 97.2% specificity for HSV-1 and 100.0% sensitivity and 98.8% specificity for HSV-2.

The IMDx HSV-1/2 for Abbott m2000 assay is part of a series of infectious disease diagnostic tests designed by IMDx for use on the Abbott m2000 system. The IMDx CE-marked test menu for use on the Abbott m2000 system includes real-time PCR assays for the detection of Group B Streptococcus, vancomycin resistant Enterococci (vanA/ vanB) and toxigenic C. difficile.

This assay is CE-marked and not available for sale in the U.S. or Canada.

Friday, July 13, 2012

FDA, UC Davis, Agilent Technologies and CDC to Create Food Pathogen Genome Database

The Food and Drug Administration (FDA), the University of California, Davis, Agilent Technologies Inc., and the Centers for Disease Control and Prevention (CDC) announced a collaboration to create a public database of 100,000 foodborne pathogen genomes to help speed identification of bacteria responsible for foodborne outbreaks.

The database will provide a roadmap for development of tests to identify pathogens and provide information about the origin of the pathogen. The tests have the potential to significantly reduce the typical public health response time in outbreaks of foodborne illness to days instead of weeks.

Open access to the database will allow researchers to develop tests that can identify the type of bacteria present in a sample within a matter of days or hours, significantly faster than the approximately one week it now takes between diagnosis and genetic analysis.

Conceived by UC Davis, Agilent, and FDA and called “The 100K Genome Project,” the collaboration will be a five-year effort to sequence the genetic code of approximately 100,000 important foodborne pathogens and make this information available in a free, public database. The sequencing will include the genomes of important foodborne pathogens such as Salmonella, Listeria, and E. coli.

“This important project will harness the cutting-edge technology of genome sequencing to advance our understanding of and response to foodborne outbreaks,” says FDA commissioner Margaret A. Hamburg, MD. “FDA is pleased to contribute scientific and technical expertise necessary to create and maintain this foodborne pathogen database which will be fully accessible and have long-lasting impact on protecting public health.

The FDA is providing more than 500 already completed Salmonella whole-genome draft sequences, thousands of additional important food pathogen strains for sequencing, and bioinformatic support. FDA scientists also will participate in guiding the project and providing technical assistance when needed.

Agilent is providing scientific expertise, instrumentation, and funding to support a portion of UC Davis activities.

With the goal of making the food supply safer for consumers, the new database will significantly speed testing of raw ingredients, finished products, and environmental samples taken during investigation of foodborne illness outbreaks. This type of information also enables scientists to make new discoveries that drive the development of new methods to control disease-causing bacteria in the food chain.

The CDC will provide its foodborne disease expertise, strains to be sequenced and other information for use in the project. CDC experts will also serve on the steering committee for the project.

“Protecting the American population from foodborne illness is a public health priority and requires the combined efforts of public and private partners,” says Beth Bell, MD, director of CDC’s National Center for Emerging and Zoonotic Infectious Diseases. “We welcome the opportunity to join in an initiative that shows promise for advancing our technological capacity for foodborne disease surveillance and outbreak response.”

Identifying the pathogens responsible for foodborne illnesses and outbreaks is only one part of the public health response. Food safety officials still need to be able to determine which food or ingredient is contaminated and where it came from. This can be a challenge, especially when multi-ingredient foods are involved or the same ingredient is sourced from multiple suppliers around the world.

When used as part of an overall surveillance and outbreak investigation system, the genetic information in the new database, in combination with geographic information about the pathogens, will help public health officials more quickly pinpoint the source of contamination responsible for a foodborne outbreak.

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) will also collaborate on the project. "This initiative shows great promise as we look to improve our ability to identify and track down potential sources of foodborne outbreaks,” says USDA under secretary for food safety Dr. Elisabeth Hagen. “FSIS intends to submit important bacterial strains from our regulatory testing program for sequencing at UC Davis, and we look forward to the benefits this public database could provide federal, state and local public health agencies."

The genomic sequencing will be coordinated by UC Davis, which is also providing access to its collection of bacteria samples. The sequencing will be done at the newly formed BGI@UC Davis genome sequencing facility.

As sequences are completed they will be stored in the National Institutes of Health’s National Center for Biotechnology Information’s public database.

As part of its efforts for the collaboration, UC Davis is currently forming a consortium to support the 100K Genome Project. The consortium participants will draw from a variety of stakeholders including Federal, state, and local public health laboratories, food manufacturers, industries, and academic organizations.

Anagnostics, Molzym Co-developing System to ID Sepsis Pathogens

Anagnostics and Molzym announced a licensing agreement and partnership to develop hybcell Pathogens DNA, a system for the rapid identification of sepsis-causing pathogens from whole blood.

Anagnostics will in-license Molzym's SepsiTest sample preparation and combine it with its compact sequencing technology for pathogen detection. SepsiTest is for DNA extraction from samples with low loads of pathogens. The DNA microbial enrichment method is based on Molzym's technology called MolYsis, which enables up to 40,000-fold DNA enrichment over conventional technologies, according to Anagnostics. MolYsis removes DNA from dead microbes, allowing for the timely monitoring of successful antibiotic treatment.

Additionally, Anagnostics said that because the technology being developed will use whole blood, the need for microbiological breeding can be circumvented and test results can be achieved in four hours, compared to one or more days with other methods.

The first tests will be available in the late fall.

Anagnostics, based in St. Valentin, Austria, develops tests and systems aimed at the pharmaceutical and clinical diagnostics spaces. On Thursday, it announced genXpress Service & Vertriebs as its distributor in Austria. Molzym, based in Bremen, Germany, manufactures products for molecular diagnostics with a focus on technologies for the selective isolation of pathogen DNA from clinical specimens.

Wednesday, July 11, 2012

Micro Imaging Technology to Showcase the MIT 1000 at the International Association for Food Protection Annual Meeting

Micro Imaging Technology, Inc. announced that it will unveil the first commercial unit of its Rapid Microbial Identification System, the MIT 1000, at the Annual Meeting of the International Association for Food Protection (IAFP) in Rhode Island -- July 22 through July 25, 2012.

Each year, the IAFP hosts an Annual Meeting, providing attendees with information on current and emerging food safety issues, the latest science, innovative solutions to new and recurring problems, and the opportunity to network with thousands of food safety professionals from around the globe. Held in various locations throughout North America, this meeting has grown over the years to become the leading food safety conference worldwide. The IAFP Annual Meeting will be held this year in Providence, Rhode Island and will be attended by more than 2,500 of the top industry, academic and governmental food safety professionals from six continents.

"The IAFP is the perfect venue to introduce the MIT 1000 to the food safety community," stated Jeff Nunez, MIT's Chairman and CEO. "This annual gathering has become the leading food safety conference worldwide and offers us the opportunity to showcase what we believe will one day be the leading diagnostic technology used in the industry."

The MIT 1000 is a stand-alone, optically-based, software driven system that can detect pathogenic bacteria and complete an identifying test in less than five (5) minutes for pennies per test. According to MIT's Chief Scientist, David Haavig, PhD, "In the US alone, around 76 million cases of food-borne illnesses, resulting in 325,000 hospitalizations and 5000 deaths, are estimated to occur each year. The leading cause of these illnesses and deaths are three main strains of bacteria: E. coli, Salmonella, and Listeria. Rapid identification of these disease-causing pathogens in food is critical to the health and safety of all consumers."

The AOAC Research Institute (AOAC RI) awarded the Company in June 2009, 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.

Tuesday, July 10, 2012

BD MAX™ MRSA Assay Receives FDA Clearance

BD Diagnostics, a segment of BD (Becton, Dickinson and Company), announced it received FDA clearance to market the BD MAX™ MRSA molecular test in the United States. The assay is performed on the fully-automated BD MAX™ System and is designed to rapidly and accurately identify patients colonized with methicillin-resistant Staphylococcus aureus (MRSA). Rapidly and accurately identifying patients enables infection control measures to be implemented faster to reduce transmission and help prevent infection in vulnerable patients.

“The BD MAX MRSA assay is an easy-to-use, cost-effective method to identify patients colonized with this deadly superbug, which may support better outcomes for the patient and a safer hospital environment,” said Tom Polen, President, BD Diagnostics – Diagnostic Systems. “FDA clearance of the BD MAX MRSA test gives our customers a new level of automation to optimize MRSA surveillance testing.”

According to the Institute for Healthcare Improvement, the total cost burden to the U.S. healthcare system from MRSA infections is estimated at more than $2.5 billion annually. MRSA infections primarily occur in people who have been in hospitals or other healthcare settings. MRSA can spread among patients or healthcare workers via direct contact with colonized patients and/or hospital surfaces. Early identification of patients colonized with MRSA helps reduce the risk of transmission and infection, and helps to improve patient outcomes.

“BD MAX is an automated, bench-top molecular system designed to perform a broad range of molecular testing, offering unmatched flexibility and versatility,” said Thomas Davis, M.D., Ph.D., Professor, Pathology and Laboratory Medicine at the Indiana University School of Medicine, and Pathologist with Wishard Health Services and Indiana University Health Laboratories. “As the BD MAX assay portfolio continues to grow, the walk-away automation, standardized workflow and ease-of-use of the BD MAX System will allow laboratories to increase both the menu and efficiency of molecular testing to better meet the demands of clinicians.”

The BD MAX MRSA assay is the second test cleared this year by the FDA on the BD MAX System. This milestone represents further confirmation of BD’s commitment to rapidly expand its menu, enabling laboratories to offer a broad range of molecular tests that meet both their current and future clinical needs.

Saturday, July 07, 2012

Roche Announces FDA Approval of HIV Viral Load Test

Roche announced that a new HIV viral load test has been approved by the United States Food and Drug Administration (FDA) and will be commercially available in the US later this year. Like other innovative Roche HIV tests, this one targets two highly conserved regions of the HIV-1 genome and avoids any regions which are current drug targets, thus providing increased reliability as compared to other single target assays should a mutation occur.

“The approval of the Roche HIV test expands the availability to more laboratories, clinicians and patients,” said Paul Brown, PhD, Head of Roche Molecular Diagnostics. “Roche is committed to developing new diagnostic tools such as this highly innovative HIV ‘dual target’ test to help improve the ability of physicians to monitor viral load and properly treat people living with HIV.”

The COBAS® TaqMan® HIV-1 Test, v2.0 utilizes the FDA-approved High Pure System Viral Nucleic Acid Kit for manual specimen preparation and the COBAS® TaqMan® 48 Analyzer for automated amplification and detection.

Roche’s dual-target approach for HIV viral load testing ensures enhanced reliability of results and increased confidence in assessing viral loads even in the face of the rapidly growing genetic diversity of HIV-1.[1],[2] This approach targets two highly conserved regions of the HIV-1 genome and avoids any regions which are current drug targets, thus providing reliable test results even with rare mismatches in primer/probe binding sites and when mutations are present. Since Roche first introduced this innovative dual-target approach for monitoring HIV-1 patients on antiretroviral therapy in 2008, over eight million tests have been performed worldwide on Roche fully automated real-time PCR platforms.

MedMira Wins $4.2 million U.S. Army Contract to Commercialize Rapid Triple Test

MedMira Inc., (MedMira), a developer of rapid diagnostic technology and solutions, announced today that it has been awarded a U.S. Army Medical Research Acquisition Activity (USAMRAA) contract to develop and commercialize a rapid test capable of simultaneous detection of HIV and Hepatitis B and C.

The contract, awarded through a competitive bid process, involves a two-year base period and a 10-month option with a value of USD$4,266,144, if all options are exercised. MedMira presented its technology and multiple rapid test, which met the U.S. Army's advanced technology readiness level requirements. The Multiplo Rapid HBV/HIV/HCV Antibody Test resulting from this contract award will be deployed on the frontlines of military healthcare for use in emergency screening for transfusion transmitted diseases where no FDA approved donor screening tests are available. The military could also put the test to use during pre and post deployment screenings and civilian disaster relief efforts.

"We are thrilled to receive this new contract from USAMRAA for the development and commercialization of our Multiplo test. This contract award demonstrates the excellent fit between MedMira's technology and products and military requirements. We have built a lasting relationship with the U.S. Army, delivering advanced diagnostic solutions that reduce the need for militaries to undertake ground-up development work," said Hermes Chan, CEO, MedMira Inc. "MedMira's technology and products are elegantly simple, portable, fast, and high quality. All of these attributes are mission critical in deploying diagnostic healthcare solutions on the frontlines of military healthcare."

Chan continued, "Our team recently attended a conference focused on military pre-hospital trauma management where we heard first hand of the need for a multiple rapid HBV/HIV/HCV test from many of the leading experts, military personnel, and medical professionals in this field."

Under contract number W81XWH-12-C-0151 the U.S. Army will fund all development costs and associated fees in obtaining a U.S. Food and Drug Administration (FDA) premarket approval (PMA) for this multiple rapid test. The scope of work under this contract will see MedMira advance and fully commercialize a multiple rapid test that will simultaneously detect three of the most serious infectious diseases, namely HIV-1/2, Hepatitis B, and C antibodies within three minutes using just a small drop of blood. Once approved, the product will be supplied by MedMira directly to the U.S. Army and to other customers throughout the world, both military and civilian, via the Company's distribution network.

"A multiplexed test for transfusion transmitted diseases provides an enabling technology that will be used to mitigate risk in austere environments where emergency blood collections are necessary to save lives of severely wounded war fighters," said Colonel Richard Gonzales, Product Manager, U.S. Army Medical Materiel Development Activity.

MedMira is a leading developer and manufacturer of flow-through rapid diagnostics and technologies. The Company's tests provide hospitals, labs, clinics and individuals with reliable, rapid diagnosis for diseases such as HIV and hepatitis C in just three minutes. The company's tests are sold under the Reveal®, Multiplo™ and Miriad brands in global markets. MedMira's rapid flow-through HIV test is the only one in the world to achieve regulatory approvals in Canada, the United States, China and the European Union. MedMira's corporate offices and manufacturing facilities are located in Halifax, Nova Scotia, Canada.

AOAC Certifies Neogen's ANSR Salmonella Assay

Neogen received Performance Tested Method Certification from the AOAC Research Institute for its new ANSR Salmonella assay, designed for fast detection of Salmonella in food and environmental samples.

Neogen introduced the ANSR rapid pathogen detection system with the Salmonella assay in May. The certification independently confirms the performance of the assay as equivalent to that of the FDA or USDA reference methods for Salmonella detection, the company said.

“ANSR is the solution for those customers who want fast and accurate results in an extremely easy-to-use format, and this certification is a confirmation of the method and the technology used in the ANSR pathogen detection system,” said Gerry Broski, food safety marketing director for Neogen.

The ANSR system uses an isothermal DNA amplification process and fluorescent molecular beacon technology for detection of a targeted pathogen, the company said. The AOAC approval covers the use of the ANSR system to detect Salmonella in food matrices for raw ground beef, raw ground turkey, chicken carcass rinse, hot dogs, oat cereal and sponge or swab samples from stainless steel, plastic, ceramic tile, sealed concrete and rubber environmental surfaces.

GPs Set for Rapid Access Diagnostics During Olympics
Saturday July 7, 2012
GPs in London will know the exact cause of gastrointestinal disease within 24 hours, as the NHS prepares for a likely increase in vomiting and diarrhoea due to the influx of visitors for the Olympics.

The Health Protection Agency said they will install new rapid diagnostic tools in laboratories as part of their ‘Games Ready' strategy in an effort to reduce the risk of outbreaks of infection.

The new diagnostic tools reduce the processing time for gastrointestinal illnesses to 24 hours rather than several days by analysing the DNA of samples, rather than growing cultures.

The new technology will be used for the duration of the Games, but if judged to be a success, it could replace traditional disease detection methods in the future.

An increase in gastrointestinal and respiratory diseases is expected due to the influx of visitors coming to the UK for the Olympics, though the HPA assures that this will be no different to the usual increase in vomiting and diarrhoea GPs expect in the winter months.

The HPA is also working with the RCGP to raise awareness in GPs about what processes to follow if patients present themselves with unusual diseases such as malaria, chikungunya and Japanese encephalitis.

These measures have been developed with a £2.5 million grant from the DH to fund additional staff. Professor Maria Zambon, director of reference microbiology services at HPA said: ‘We would expect that the speed of the response will be much quicker than that GP is used to dealing with.

‘The public health authority branch can then step in to whether intervention is needed at the source of the disease to prevent onward contamination.'

‘It shouldn't make too much difference to what the GP says to the patient. They might still give symptomatic advice such as "go home, drink lots of fluid and wash your hands after meals and going to the toilet"'.

Dr Brian McCloskey, HPA Olympics lead and director for London said the HPA will be providing expert advice on how to respond to and limit any threat to public health.

He added: ‘We are writing to healthcare professionals across the UK reminding them to be alert for unusual presentations and report symptoms of infectious disease promptly.'

Monday, July 02, 2012

Accelr8 Presents Two Studies at ASM 2012 and Receives Acceptance to Present a New Blood Study

Accelr8 Technology Corporation announced results of two studies that it presented at the 112th annual General Meeting of the American Society for Microbiology.

The first study used the company’s BACcel™ rapid automated diagnostic system with positive blood cultures to detect a major, complex multi-drug resistance expression type known as “ESBL.” The system’s 3-hour results showed the benefits of the platform decreasing time to result by 1-2 days over the best standard method while maintaining 100% sensitivity and 94% specificity. ESBL resistance has spread globally with hundreds of molecular variants. Early ESBL spread occurred in hospitals, but is now reaching into community-acquired infections. These resistance types are difficult to detect and severely reduce treatment options in the largest family of Gram-negative pathogens.

The second study reported performance of the company’s rapid, fully automated specimen preparation technology. It showed that in 10 minutes or less, the BAC-Xtrax™ gel electrofiltration system concentrates live bacteria and substantially clears the sample from complex interference. The BAC-Xtrax™ concentrated live cells more than 100-fold from the original samples, exceeding the best standard method by more than 10 times. It recovered essentially all of the organisms in the samples, with variation comparable to that of the quantitative culturing reference method.

Separately, Accelr8 also received notice of acceptance to present results at ICAAC 2012 for a new study entitled “Same-Day Blood Culture with Digital Microscopy.” The study examines alternatives for shortening the currently typical overnight delay for cultures before beginning analysis of blood-borne infections.

Device Would Let Clinicians Screen for Bacteria, Pick Best Antibiotic In An Hour

Lately we’ve seen a lot of rapid diagnostics for bacterial infections like MRSA, tuberculosis and streptococcus. This early-stage startup is doing it a little differently: it’s focusing less on identifying the bacteria and more on rapidly determining what antibiotic would best treat it.

DxUpClose Inc.’s CEO Cyndi Nickel said the company’s handheld device screens a fluid sample for specific pathogenic bacteria, but even if it can’t identify the bacteria that are present, it will count the bacteria and perform an antibiotic sensitivity test on them, all in an hour’s time.

The point-of-care diagnostic device contains samples of antibiotics, and electronic sensors within the device monitor the growth of bacteria from a sample under the influence of those antibiotics. The device then sends a list of recommended antibiotics to the healthcare worker’s email or smartphone.

“A lot of the bacterial tests out there use PCR, which is a technique of attaching DNA on to a probe,” Nickel said. “Ours is strictly based on the electronic sensor and the sensor’s ability to monitor the bacterial activity.”

Nickel said it’s the device’s ability to do this in 60 minutes that sets it apart from competing antibiotic sensitivity tests, like Vitak’s Advanced Expert System software, which require several hours of incubation. What also sets it apart is that is weighs less than one pound, runs on batteries and is designed to fit into a doctor or nurse’s coat pocket.

It’s designed to save time and dollars resulting from improperly prescribed antibiotics and returns to the doctor’s office. With $26 billion spent on antibiotics every year that seems like a good problem to be solving. But the problem of drug-resistant resistance has inspired some alternate approaches to treating bacterial infections (new therapeutic drugs, devices and vaccines) beyond today’s antibiotics that may come into play down the road. Would the device be able to address those?

DxUpClose is targeting a $825,000 in a Series A offering that will carry it through the rest of the development phase.

Nickel said the device’s initial application will be in treating urinary tract infections, and she anticipated that it would be ready for FDA submission in 18 months to two years. Its platform is based on technology developed at Texas A&M University and in partnership with Texas State University.

Irish Researchers Develop Rapid TB Test

A team of researchers at the National University of Ireland – Galway has developed a new tuberculosis test that can identify which bacteria are causing the infectious disease.

Thomas Barry, a microbiology lecturer at the school, and his colleagues at the university’s molecular diagnostics research group, developed the SeekTB test, which takes between 90 minutes and three hours to produce results. The diagnostic DNA test rapidly confirms the type of bacteria in an effort to improve the effectiveness of treatment, Irish Times reports.

A group of eight bacteria called the mycobacterium tuberculosis complex can cause TB in humans. Some of the bacteria are naturally resistant to some of the drugs used frequently in treatment. A test that distinguishes which of the eight bacteria caused the infection may help researchers to determine which drugs are most effective against particular kinds of bacteria.

Scientists from Germany and the Netherlands helped the team to validate the SeekTB technique, according to Irish Times.

According to the World Health Organization, tuberculosis is second to only HIV/AIDS as the greatest cause of death by one infection. Most cases and fatalities occur in developing nations. In 2010 alone, nearly nine million people were infected with TB and 1.4 million people died as a result.