Food Safety Testing Labs Evaluate PathoGenetix Microbial Strain Typing System

PathoGenetix, Inc., developer of an automated system for rapid bacterial identification, announced today that it has completed the first round of customer evaluations for its RESOLUTION™ Microbial Genotyping System. The RESOLUTION Customer Experience Program gives key prospects in critical target markets a hands-on, in-depth review of the company’s rapid bacterial identification system, and is an important step in the commercialization of the System, which will be available in 2014 for use in food safety testing and foodborne illness outbreak investigations.

The RESOLUTION Customer Experience Program enables potential customers to visit PathoGenetix and participate in a two-day workshop that provides a detailed review of the RESOLUTION Microbial Genotyping System including hands-on time with the instrument, bioinformatics software and database, and pathogen-specific assays for Salmonella and E. coli. Customer feedback on user requirements, utility and ease-of-use of the System is also a key component of the Program.

PathoGenetix’s first round of onsite evaluations focused on leading contract testing labs serving the food safety market. Many food producers worldwide rely on third party contract laboratories for all or part of their food quality and safety testing programs.

Wisconsin-based Marshfield Food Safety, LLC, was one of five contract testing laboratories to visit PathoGenetix in October and November for the RESOLUTION Customer Experience Program. Marshfield provides full service microbiology and chemistry testing and food safety risk management services to clients along the food chain from farm to table.

Marshfield CEO, Roy Radcliff, PhD, said of the potential impact of the RESOLUTION System on food safety testing, “The RESOLUTION System could change how pathogen confirmations are performed in testing laboratories. The ability to identify and differentiate multiple serotypes from a single sample could give our customers the ability to quickly identify sources of contamination and track specific organisms through a production facility.”

“The RESOLUTION Customer Experience Program provides important input for PathoGenetix as we develop our innovative technology into a powerful new food safety solution for the food industry and public health agencies,” said John Czajka, PhD, PathoGenetix’s Vice President of Business Development. “By offering industry experts the opportunity to work with the RESOLUTION System, they have been able to see first-hand both the simplicity of the System and its exceptional pathogen characterization capabilities. PathoGenetix has been able to get detailed customer feedback that will enable us to fine tune the System to further match end-user requirements and existing laboratory workflows.”

PathoGenetix will be offering the RESOLUTION Customer Experience Program again in 2014, with a focus on food production companies that conduct food safety testing in-house.

About PathoGenetix, Inc.

PathoGenetix, Inc. is a commercial-stage developer of an automated system for rapid bacterial identification from complex samples. PathoGenetix is a venture-backed company that has received more than $50 million in technology development funding from the Department of Homeland Security. The company’s core Genome Sequence Scanning™ (GSS™) technology isolates and analyzes DNA directly from an enriched biological sample—without the need for a cultured isolate—and provides results in just five hours, days faster than current methods. GSS has broad applicability in food safety, industrial microbiology, and clinical diagnostics and research. The first commercial GSS system will be available in 2014 for use in food safety testing and foodborne illness outbreak investigations.

Read more

Improved Rapid Molecular Testing May Become Available in Office Setting

Rapid molecular tests for viruses and other infections may soon become widely available and could help with decisions regarding antibiotics, according to a presenter here at the 26th Annual Infectious Diseases in Children Symposium.

Gregory A. Storch, MD, director of the division of pediatric infectious diseases and pediatric laboratory medicine at the Washington School of Medicine, discussed the history of diagnostic virology and the rapid shift to molecular testing. Molecular and diagnostic tests are available for an array of viruses, including respiratory, gastrointestinal, and mucocutaneous/genital using blood and urine samples, and many more are on the way.

Currently available tests

Because multiple infections are relatively common in children, with rhinovirus being the most common, the rapid turnaround time with molecular testing also helps facilitate clinical and infection control decisions. This type of testing also is able to detect antiviral resistance mutations, according to Storch.

Storch reviewed a few of the available tests that will help “guide the road to the future,” he said. These include the GeneXpert test, which is simple to perform and sensitive for a broad range of enteroviruses. Results of the test are usually available within 2.5 hours, making diagnosis quick. However, it does not detect parechoviruses.

Respiratory virus multiplex assays are able to detect multiple agents in the same sample and several assays are licensed for detection of influenza A/B and respiratory syncytial virus. Other multiplex assays can detect some or all of the following: influenza A/B, influenza A(H1), influenza A(H1 2009), influenza A(H3), parainfluenza virus (1-4), adenovirus, human metapneumovirus, and rhinovirus coronavirus (OC-43, 229E, NL63, HKU1). Turnaround time for these tests is 1 to 8 hours, depending on the assay, Storch said.

The BioFire FilmArray Respiratory Panel can give results within 60 minutes; however, the instrument only accommodates one sample at a time.

Tests in development

Storch said some tests currently in development are being designed for quick and easy use because these types of tests are desperately needed in the developing world and areas with limited resources.

“However, the very same characteristics that would make a test useful in a developing world are the same characteristics that would make a test useful in the office,” Storch said during the presentation.

In the future, most testing will be molecular with an emphasis on assays that are simple, sensitive, single or multiplexed and rapid, he said. Multiplex testing will include both viral and nonviral pathogens. Information from human genes may be incorporated into the testing.

“If I can look into the future, one of the ways we may overcome the quandary of overdetection of asymptomatic viruses is to add on detection of human genes that are indicative as to whether the patient is reacting to a bacterial infection, a viral infection, or both," Storch said.

High throughput sequencing will allow new pathogen discovery, recognition of new strains, enhanced detection of antiviral resistance and recognition of virulence determinants.

Read more

Rapid Sequencing Method Can Identify New Viruses Within Hours

In 2009, two teenagers in the Democratic Republic of Congo showed up at their village health clinic, vomiting and with blood in their noses and mouths — hemorrhagic symptoms of the notorious Ebola viruses. In three days they were dead.

Yet it took three years for researchers to unmask the likely culprit: a brand-new virus called Bas-Congo, which is not related to Ebola or any other virus known to cause severe hemorrhagic fever.

It can take weeks or months to identify a novel virus, and much longer if the sample must be sent to a specialized lab, as the Bas-Congo virus was. Such lags are too long, says virologist Charles Chiu, director of the Viral Diagnostics and Discovery Center at the University of California in San Francisco.

Deciphering a virus’s genetic code is the critical first step in determining how fast it might spread, identifying possible treatments and even finding vaccines. Viruses like the one that killed the Congolese teens can quickly go global, and traditional methods for identifying viruses, which only test for one pathogen at a time, could mean sacrificing untold lives.

But Chiu and his colleagues have found a way to speed up virus identification — a method they hope will one day help health care workers in remote areas identify new viruses as soon as they appear, as long as they are able to access the Web.

The team conducted a proof-of-concept test in which they eventually identified the Congolese virus.

Typically, it takes three months to piece together a complete viral genetic code. The new process can identify an unknown virus in less than two hours, and Chiu’s team can put together the entire genetic code of a virus in a single day.

Chiu’s colleagues are working to get more DNA sequencers — and expertise to use them — into the hands of health care workers in potential virus hotbeds. Meanwhile, Chiu and his team hope to put their virus-identifying system on the Web so health workers anywhere can access it.

Chiu’s vision: When patients show up at a clinic with an unknown pathogen, health care workers could take swabs and run DNA sequences onsite, then use smartphones or laptops to feed the results to an online network that would deliver results in minutes.

Proof-of-Concept Test

1. Starting with a sample of the Bas-Congo virus, Chiu and colleagues first grew the virus in culture, then extracted its genetic material and made millions of copies.

2. Next, they put the samples into an instrument called a DNA sequencer — which automatically analyzes genetic material — to read short viral gene fragments millions or even billions of times.

3. Finally, they ran the results through a software program that combed through many gene sequences simultaneously, comparing each one with the sequences of known viruses stored in online databases. This process allowed them to home in on the identity of the virus.

Read more

FDA and Vivione Biosciences Enter into a 3-Year Cooperative Diagnostic R&D Agreement

Vivione Biosciences Corporation announced a new three-year Cooperative Research and Development Agreement (CRADA) with the Food and Drug Administration's (FDA) National Center for Toxicological Research (NCTR). The focus of the CRADA is to expand the capability of Vivione's RAPID-B(TM) diagnostic system.

The Vivione RAPID-B(TM) system is a revolutionary high-performance diagnostic system for detecting bacterial pathogens. Unlike other systems that look at a gross response of an entire sample to provide information, the RAPID-B(TM) system looks individually at each bacterium's physical properties (including size, shape, and transparency) and analyzes unique responses to probes and DNA dyes. RAPID-B(TM) allows the testing of food products in seven hours or less, including sample preparation versus other commercial systems that take up to 48 hours to provide results. Moreover, single shift results are achieved without the need for labor intensive sample preparation steps including centrifugation and immuno-magnetic separation.

The implication for the general public is that RAPID-B(TM) can yield better and faster micro results than current methods, making food and consumer products safer. "New research contemplated under the CRADA will augment the present RAPID-B(TM) assays for food safety," said Ted Moskal, Vivione's President and Chief Science Officer. "We are developing new methods that can rapidly identify the pathogens responsible for disease outbreaks beyond food-borne illnesses." Moskal further explained that the new research will expand to include the tiniest disease-causing agents known to man, particularly viruses and prions, for which there are no current detection methods available.

CEO of Arkansas Research Alliance, Jerry Adams said, "I'm very pleased NCTR-FDA has entered into a CRADA with Vivione. The relationship between government research and commercial entities is important for the development of new technologies and employment. The development of better, faster and less expensive diagnostics is both key to maintaining a safer food supply and also to yield better outcomes for identification of infectious disease in clinical settings. The Research Alliance is hopeful that this collaboration will lead to the development of new diagnostics, the growth of biosciences in the state and more knowledge-based jobs."

In both clinical as well as food safety settings, very low pathogen levels can cause human morbidity and mortality, particularly in such susceptible populations as the elderly, children and immune-suppressed individuals. RAPID-B(TM) has the ability to detect extremely low levels of infectious agents in complex biological matrices, thus potentially increasing early diagnoses, specifically in time-critical situations.

Overall the research under the CRADA will strive to expand the utility of RAPID-B(TM) to a greater variety of locations and contexts, including field settings and clinical venues. According to Moskal, the goal is to design and test new RAPID-B(TM) assays capable of real-time detection of diverse pathogens directly from the native sample thus reducing the steps associated with typical sample preparations and yielding faster, simpler and cost-effective diagnostic tests.

Arkansas Governor Beebe said, "The State of Arkansas applauds the new Cooperative Research and Development Agreement between the FDA National Center for Toxicological Research and Vivione Biosciences. Public-Private partnerships for research are critical to the development of new products that benefit the public and keep America competitive. The biotech sector is increasingly more important to the generation of knowledge-based jobs. We're so proud that both organizations are located in the state of Arkansas."

Read more

Rapid Testing Leads to More Efficient Care for Influenza Patients

The University of Utah School of Medicine published study results on Thursday in the Journal of Pediatrics Infectious Diseases Society that suggest diagnosing influenza with a rapid diagnostic test leads to more efficient care.

Researchers used data from the National Hospital Ambulatory Medical Care Survey to identify children and adults diagnosed in the emergency department with influenza during the 2007-2009 flu seasons. Researchers compared the diagnostic tools with the proceeding treatment.

Patients diagnosed with the flu without using rapid testing received a prescription for antibiotics in 23 percent of the cases, which are not effective in treating the virus.

Patients diagnosed using rapid testing were prescribed antibiotics in 11 percent of cases. Additional laboratory tests, such as X-rays, blood tests and urinalysis, were also ordered less frequently.

Prescriptions for antiviral drugs were present among 56 percent of patients diagnosed using a rapid test, compared to 19 percent of patients diagnosed without rapid testing.

“When results of influenza tests are available to physicians at the ‘point of care,’ they use this information to provide more appropriate patient management,” Anne J. Blaschke, the lead study author from the University of Utah School of Medicine, said. “While other studies have shown that physicians can accurately diagnose influenza without testing, our results suggest that using an influenza test increases diagnostic certainty and leads to the physician providing more specific and appropriate care.”

Researchers said the study results suggest rapid testing has a significant impact on patient care and use of health care resources. They concluded that the development of more accurate and faster tests would further improve patient care for influenza and other respiratory illness.

Read more

Diagnosing Sepsis More Quickly

A research team from bioMérieux reports the development of a new method that, they say, could cut hours off the time it takes to diagnose blood infections while also eliminating the need for complicated manual processing and expensive equipment. The scientists reported their study (“Rapid Intrinsic Fluorescence Method for Direct Identification of Pathogens in Blood Cultures”) in mBio®.

The technique combines a selective lysis step in which blood cells in the sample are destroyed, a centrifugation step to collect any bacteria or fungi in the sample, and a fluorescence step that analyzes the particular fingerprint of any pathogens present in the sample. Tests show the method correctly identifies the species of bacteria or fungi in 96.5% of positive blood culture samples, crucial information for doctors to provide the appropriate drugs for their patients.

“A total of 1,121 monomicrobial-positive broth samples from 751 strains were analyzed to build a database representing 37 of the most commonly encountered species in bloodstream infections or present as contaminants. A multistage algorithm correctly classified 99.6% of unknown samples to the Gram level, 99.3% to the family level, and 96.5% to the species level,” wrote the investigators. “There were no incorrect results given at the Gram or family classification levels, while 0.8% of results were discordant at the species level. In 8/9 incorrect species results, the misidentified isolate was assigned to a species of the same genus. This unique combination of selective lysis, density centrifugation, and IFS can rapidly identify the most common microbial species present in positive blood cultures. Faster identification of the etiologic agent may benefit the clinical management of sepsis.”

“The primary benefit of getting a rapid identification is making sure the patient is on the right [antibiotic] therapy and to quickly make any needed adjustments to the initial therapy,” says co-author John Walsh of bioMérieux.

Walsh says the current standard approach to diagnosing bloodstream infections, Gram staining and overnight sub-culture followed by phenotypic ID tests, have limitations that can prevent timely treatment. Gram staining provides early, low-level information about the type of microorganism present, but it sometimes takes hours to deliver a result, and technicians can make mistakes in the process that provide misleading results. Other more specific identification methods are also available for diagnosis, but they can take at least a day or two to produce results and many require expensive equipment.

Read more

Analysis of E. coli Strains Compares Whole Genome Sequencing, PFGE and Genome Sequence Scanning

PathoGenetix Inc., a developer of an automated system for rapid bacterial identification, and Applied Maths, NV, a leader in bioinformatics and analytical solutions for public health and research laboratories, presented a novel study at InFORM 2013 comparing comparing three different genomic methods for typing bacterial pathogens: the new technologies, whole genome sequencing (WGS) and Genome Sequence Scanning™ (GSS™), and the traditional pulsed field gel electrophoresis (PFGE). PFGE is the current standard for pathogen identification in foodborne illness outbreak investigation and response.

The BioNumerics® software suite (Applied Maths) was used to analyze a data set of 190 pathogenic E. coli strains from the Centers for Disease Control and Prevention (CDC). Clustering of related strains was performed using patterns generated by PFGE and whole genome sequence data included in the CDC data set, and GSS fingerprints, PathoGenetix’s proprietary technology used in the RESOLUTION™ Microbial Genotyping System. For the set of E. coli isolates tested, the analysis shows a remarkably high congruence between the GSS groupings and WGS groupings, while maintaining a good concordance with the PFGE groupings. With respect to WGS, the GSS groupings also turn out to be more discriminatory than the PFGE groupings.

The results point to the potential use of the RESOLUTION System to provide critical strain information in a culture independent diagnostics environment, and to considerably reduce the time involved in outbreak investigation and response. The RESOLUTION System can work from a mixed sample and does not require the preparation of a cultured isolate, as is the case with whole genome sequencing and PFGE, and provides strain type and serotype results in less than five hours.

The collaborative research is detailed in a poster presented yesterday at the InFORM 2013 (Integrated Foodborne Outbreak Response and Management) meeting being held this week in San Antonio, Texas. InFORM meetings are designed to coordinate and enhance the work of microbiologists, epidemiologists and environmental health specialists focused on foodborne disease surveillance, outbreak detection and response. The meeting is sponsored by the CDC, the Association of Public Health Laboratories (APHL), the U.S. Department of Agriculture Food Safety and Inspection Service (FSIS), and the Food and Drug Administration (FDA), and integrates the separate PulseNet and OutbreakNet annual meetings held in previous years.

Applied Maths and PathoGenetix signed a collaborative agreement in June to integrate the RESOLUTION Microbial Genotyping System with the BioNumerics software suite. The two companies have a first working version of the new functionality ready, which integrates PathoGenetix’s rapid pathogen strain typing with BioNumerics’ advanced data management and networking tools. The plug-in will enable sharing and comparison of outbreak strain data among public health or food safety testing labs, and the comparison of serotype and strain type information generated by the RESOLUTION System with data sets generated by other identification methods such as PFGE or whole genome sequencing.

PathoGenetix’s RESOLUTION System is an automated instrument that utilizes Genome Sequence Scanning, the company’s breakthrough genotyping technology that isolates and analyzes microbial DNA directly from complex mixtures in five hours. The fully automated System combines rapid throughput scanning and proprietary software to generate genomic fingerprints based on the underlying sequence, compare them to an onboard database, and provide molecular serotype and strain type information for all target bacteria present in the sample at detectable levels.

Applied Maths’ BioNumerics is a turnkey software suite for integrative biological data management and comparative analysis that includes fingerprint and sequence analysis, data mining, clustering, identification and statistical applications. BioNumerics software is currently in use in thousands of public and private research sites and laboratories worldwide, and is the cornerstone for numerous national and international research projects and epidemiological surveillance networks.

Read more

Corgenix and Zalgen Collaborate on Developing Infectious Disease Diagnostic Test

Corgenix Medical Corporation, a worldwide developer and marketer of diagnostic test kits, announced today that it has entered into a collaboration agreement with Zalgen Labs, a biotechnology company dedicated to the development of multiple diagnostic testing platforms and immunotherapeutics for high impact neglected infectious diseases.

Both companies will work collaboratively to investigate the feasibility of developing a "next generation" rapid test kit for the early detection of active cytomegalovirus (CMV) infections, and previous exposure to the virus in women of childbearing age. Congenital birth defects and disabilities associated with active CMV infections are one of the most common causes of birth defects in the U.S. and worldwide.

"This exciting collaboration with Zalgen has great potential to impact health care in the U.S. and globally," said Douglass Simpson, President and CEO of Corgenix. "Our work is focused on development of point-of-care diagnostic products with the ability to help millions, and it represents a huge market potential, with an estimated demand for four million tests per year in the United States alone."

There are no FDA cleared point-of-care tests for CMV, and testing currently requires the drawing of fluid from the amniotic sac for CMV testing.

"Introduction of a rapid, point-of-care test for early assessment of CMV status in women of childbearing age is long overdue, and will greatly aid in reducing potentially devastating birth defects associated with active CMV infections during pregnancy," said Luis M. Branco, Ph.D., Co-Founder of Zalgen Labs.

Corgenix' role in the collaboration includes the design of rapid test prototypes for CMV detection based on its proprietary viral hemorrhagic disease detection technology. If successful, the tests would be further developed to prepare for clinical trials.

Both Corgenix and Zalgen are members of the Viral Hemorrhagic Fever Consortium, working to develop state-of-the-art diagnostic products for biothreat agents and emerging pathogens.

Read more

Eurofins and Celsis Partner to Provide Cost-Effective and Rapid Pharma Microbiology Services

Eurofins Lancaster Laboratories, the global leader in bio/pharmaceutical GMP product testing, and Celsis International Ltd., the global leader in rapid microbial detection systems, announced that they have entered into a collaboration through which Eurofins Lancaster Laboratories will provide contract rapid microbiology validation and screening services for the Celsis rapid detection technology platform.

The Celsis rapid detection system allows companies to ensure that their products meet microbial specification 60 – 80% faster than traditional methods. The decrease of as many as 7 to 10 days in production cycle times results in reduced inventories and working capital requirements in addition to providing earlier notification of microbial excursions when they occur.

“The pharmaceutical industry has begun to embrace the cost savings that the Celsis method can bring to their operations,“ said Judy Madden, Vice President of Corporate Development for Celsis. “We’re working with some of the pharmaceutical industry’s leaders to implement the Celsis method for microbial limits and sterility testing but many don’t have the resources or expertise to complete the validation work required before implementation. Eurofins Lancaster Laboratories’ expertise in this area will ensure high-quality validations and streamline the implementation process for our customers.”

With 50 years of delivering outstanding testing services, Eurofins Lancaster Laboratories has a stellar reputation for excellence in service quality and data reliability, enjoys long-standing relationships with many Fortune 500 clients and is part of the largest network of harmonized bio/pharmaceutical GMP product testing laboratories worldwide.

“We are pleased to have expanded our rapid technologies service offerings with the Celsis system in response to this industry need,” said Mark Kaiser, Director of Pharmaceutical Microbiology. “We have the Celsis system fully operational in both our US and Irish facilities, and both sites have initiated validation projects under contract. In addition to these, we anticipate that some of our current client base will move their routine microbiology testing to the Celsis method accelerating product release.“

Judy Madden added, “We’re excited that this collaboration will further advance the development of our pharmaceutical initiative by addressing an unmet market need.”

Read more

New Rapid Indicator Organism Testing for Food Processors

MOCON, Inc. has now added rapid “indicator organism” testing capability to its proven GreenLight® microbial detection platform, reducing test time up to 60 percent.  In addition to the previously available total count testing capability, the GreenLight system now is able to simultaneously test for enterobacteriaceae and total coliform counts using an oxygen depletion sensor and automated reader.

Food processors will be able to significantly benefit from more extensive quantitative test results in 10 hours or less, vs. the 24 hours required by traditional methods.  Target applications include dairy, cheese and meat, as well as sanitation initiatives.

“These indicator tests are a key component of food safety programs because they can predict the possibility of contamination by organisms that cause diseases in humans.  The more rapid the test results, the faster food processors can make decisions regarding the use of perishable incoming raw materials and outgoing products.  Shortening the testing cycle helps contribute to a safer overall food supply,” said Alan Traylor, business manager, microbial detection, MOCON.

The GreenLight system is configured to allow quantitative data and pass/fail testing in a fully automated mode. One of the most attractive features of the GreenLight system is that results from higher bacterial loads are achieved more quickly. This allows the user to set a pass/fail limit and be warned of failures in a much shorter time than traditional plate count methods—which require 24-72 hour incubation time regardless of bacterial load.

Food processors also benefit from shorter preparation times due to the elimination of serial dilutions.  The simplified prep process reduces cost and decreases the chance of lab error.  Additionally, GreenLight’s “objective” test protocol does not rely on plate counting, thereby further reducing errors and creating the ability to save quantitative information in a secure database for future reference.

The GreenLight food safety product line is part of MOCON’s Microbial Detection business unit.  Its objective is to provide automated rapid, precise, same-day microbial count results in a cost-effective manner with reduced process variability.

Read more

New Microarray for Identifying and Subtyping Pathogenic E. coli Using Unique DNA Signatures

Affymetrix, Inc. announces the availability of a multi-genome pathogen microarray, designed by the Food and Drug Administration's Center for Food Safety and Applied Nutrition (CFSAN) and built by Affymetrix, for the detection and identification of pathogenic E. coli during foodborne outbreaks. These high density DNA-based microarray assays, for use with the GeneAtlas(R) Personal Microarray System, can detect, discriminate, and uniquely identify strains of E. coli on food products, clinical samples, and environmental samples in real-time outbreak situations.

This custom designed microarray contains tens of thousands of biomarkers mined from over 250 E. coli whole genome sequences, making it a true representation of the E. coli PanGenome. In addition to containing every known E. coli gene (>40,000), the design contains over 10,000 highly informative single nucleotide polymorphism (SNP) biomarkers. As a result, this hybrid array is highly discriminatory as well as biologically and evolutionarily informative. Furthermore, by employing Affymetrix array strip technology, the microarray assay is rapid (<24 hours), high throughput, semi-automated, and affordable.

The Minimal Signature E. coli Array (FDA-ECID) is the culmination of seven years of research and development by FDA's Division of Molecular Biology. The choice of targets to include on the pathogen identification array were selected as part of a rational design strategy based in large part on data obtained from past outbreak investigations where several previous Affymetrix custom array designs were utilized; including GeneChip(R) E. coli Genome 2.0 Array and the FDA-E. coli-Shigella (ECSG) array.

In real-time outbreak investigations, FDA's comparative genomic studies demonstrate rapid identification and clear discrimination between clinically, temporally, and geographically distinct events.

The array is a complete package for genomic-scale molecular subtyping of foodborne pathogens. When used with FDA's Microbial ArrayTrack(TM) software, users will have a turn-key, customized solution for microarray data storage, analysis, and visualization.

Microbial ArrayTrack was developed by bioinformaticists at FDA's National Center for Toxicological Research (NCTR) from the ground-up as a high-end microarray data storage, analysis, and visualization package. As such, Microbial ArrayTrack now contains ECID-specific annotations in conjunction with a customized and validated data analysis and visualization solution.

"Affymetrix is pleased to see our long term relationship with the FDA result in a foodborne pathogen monitoring tool. The key to preventing widespread outbreaks is to detect and identify contaminants and foodborne illness as quickly, accurately, and easily as possible. Integrated genomic/bioinformatic solutions are indispensable tools in food safety applications providing rapid answers to serious questions," said Dr. Kevin Cannon, SVP of the Expression Business Unit at Affymetrix.

This array is now available to the community from Affymetrix.

PLEASE NOTE: Affymetrix, the Affymetrix logo, GeneAtlas, and GeneChip trademarks are the property of Affymetrix, Inc. All other trademarks are the property of their respective owners.

Read more

ProteinLogic Awarded Grant for Rapid Tuberculosis Test

Ithaka is pleased to announce that ProteinLogic, a biomarker discovery and exploitation company, Microtest Diagnostics, an in vitro diagnostic protein multiplexing company, and its collaborators have been awarded a grant by the Technology Strategy Board (TSB) to help support the development of MICROLOGIC™, a rapid point-of-care test for tuberculosis. Ithaka’s founder and Managing Director, Dr Paul Rodgers, is Executive Chairman of ProteinLogic.

Almost 9m new cases of TB occur annually and there are over 1m deaths every year despite most cases being curable. More than 3m people contracting TB each year go undiagnosed and untreated according to the World Health Organisation. WHO is now calling for accelerated uptake of new tools and strategies for better diagnosis, treatment and prevention of all forms of TB. The MICROLOGIC™ test will enable the rapid differentiation of the active and latent forms of TB using a simple blood sample that can be taken and analysed at the point-of-care.

The three year £1.8m project will integrate ProteinLogic's unique panel of biomarker proteins with Microtest Diagnostic’s CE-marked rapid diagnostic platform which can rapidly determine levels of multiple proteins in blood within a few hours and is suitable for use in a local doctor’s office. The Technology Strategy Board funding will be used to create a prototype device for rapid, point-of-care human TB diagnostics.

The consortium has been enhanced by the expertise of various global academic TB Groups who are currently working in the field to help eradicate the disease and who understand, first hand, what is needed for a rapid TB diagnostic. These include the London School of Hygiene & Tropical Medicine (LSHTM), the University of Sheffield and the University of Cape Town (UCT) in South Africa. Dr Ruth McNerney of LSHTM and Prof Keertan Dehda of UCT are members of the STOP TB Working Group on New Diagnostics and Dr McNerney chairs the subgroup on point-of-care tests. She is also an advisor to the UK All Party Parliamentary Group on TB.

ProteinLogic’s Chairman Dr Paul Rodgers said: “We are thrilled that the Technology Strategy Board is funding this exciting collaboration. We are looking forward to working with our partners to develop a prototype device and accelerate the application of this innovation to the benefit of patients.”

Read more

MedMira to Collaborate with the National Research Council of Canada on Advanced Sensitivity and Automated Detection in Future Rapid Diagnostics

MedMira Inc., (MedMira), a developer of rapid diagnostic technology and solutions, today announced a collaborative research agreement with the National Research Council of Canada (NRC). MedMira is aiming to advance its rapid diagnostic technology through the creation of a next generation rapid diagnostics platform, specifically for diseases and conditions which today can only be diagnosed using traditional laboratory based tests, processes, and equipment.

MedMira will receive funding support towards this research from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP).  MedMira and NRC will work together over a 10 month period on two key areas that will expand the capabilities of MedMira's rapid diagnostic technology platform. The first will develop new nanoparticles that are more visible than traditional particles, allowing earlier diagnosis of diseases. In addition to making the detection more sensitive it also broadens the scope of applications that can be built on the rapid flow-through technology platform. With these advancements, certain diseases and medical conditions, which today may be below the detection limits for all rapid assays, could soon be detected in minutes, at the point-of-care, using a MedMira rapid test.

"This is a valuable opportunity to bring together research and development efforts from both MedMira and the National Research Council to deliver superior healthcare tools more rapidly than we could alone," said Dr. Neeraj Vats, Director of Technology and Business Affairs, MedMira Inc.

The second advancement will involve NRC and MedMira conducting research and development activities leading to the addition of non-visual detection in the rapid diagnostic platform. Automating the reading and recording of test results brings significant operational efficiencies to healthcare providers, faster treatment for patients, and better surveillance data in large scale screening programs run by health departments and aid organizations.

Dr. Vats added "In addition to broadening the scope of applications that can be created on rapid tests, we are also working to enhance the user experience. The development of simple instrumentation that can interpret, record and transmit results in real-time to specialists that can determine treatment options will be very powerful, and mean that specialists no longer have to be in the same room or the same country as their patient, which will enable better care."

Read more

LabCorp Announces New Rapid HIV Diagnostic Tools

Laboratory Corporation of America Holdings announced that its 4th generation HIV antigen-antibody combination assay is now available, along with a new rapid HIV screening diagnostic tool.

LapCorp’s new 4th generation assay can detect both types of HIV antibodies, IgG and IgM, and the HIV p24 antigen before seroconversion occurs in the body. The new assay can also detect infection in acutely infected individuals approximately seven days sooner than its 3rd generation assay, improving treatment efficacy and helping reduce the spread of HIV globally.

“Fourth-generation HIV screening and associated supplemental testing is a valuable addition to the tools available to achieve early diagnosis of HIV,” LabCorp Chief Medical Officer Dr. Mark Brecher said. “Detection of acute infections using the fourth-generation assay provides an improved opportunity for early intervention and the potential to affect transmission rates.”

LapCorp also announced the completion of a new, highly sensitive algorithm diagnostic tool used as a second step in the diagnostic process, following the 4th generation assay, both to confirm the HIV diagnosis and determine if a patient is infected with an HIV-1 or HIV-2 infection.

The Clinical Laboratory Standards Institute and the New York State Department of Health recommend the use of LapCorp’s algorithm diagnostic technology for HIV screening. The Centers for Disease Control and Prevention also endorse the test and published two positive reviews of the diagnostic tool online in its Morbidity and Mortality Weekly Report. It is considered cost-effective and highly accurate.

Read more

Novel Molecular Assay for MRSA Active Surveillance Detects Newly Discovered Strains of Drug-Resistant Superbug

BD Diagnostics, a segment of BD (Becton, Dickinson and Company), a leading global medical technology company, announced the availability of the CE-marked BD MAX MRSA XT assay in Europe for use on the BD MAX(TM) System. The assay uses eXTended detection technology to accurately identify a broad range of methicillin-resistant Staphylococcus aureus (MRSA) strains from nasal swabs in patients who may be colonized with this drug-resistant pathogen. It is the only fully-automated molecular assay for MRSA active surveillance that detects a specific target found in MRSA (MREJ) and drug-resistance genes: mecA and the recently discovered mecC.

Active surveillance using molecular tests for rapid detection of MRSA is a proven strategy to reduce transmission in healthcare settings and helps to prevent infection in vulnerable patients. Inaccurate detection may contribute to uncontrolled transmission of MRSA and inappropriate use of healthcare resources.With many commercial assays, Staphylococcus aureus strains where the mecA gene is absent (commonly called "dropout mutants") are incorrectly detected as MRSA. These false positive results can lead to unnecessary and expensive isolation as well as patients being over treated. MRSA strains with the newly discovered mecC gene account for nearly three percent of all new MRSA cases[iv] but cannot be detected by assays that do not detect that gene. These false negative results can lead to uncontrolled transmission of undetected MRSA strains.

"Assay design is critical to detect MRSA accurately and ensure that appropriate infection control interventions are applied," said Dr. Patrick Murray, Worldwide Director of Scientific Affairs, BD Diagnostics - Diagnostic Systems. "The new BD MAX MRSA XT assay uses eXTended detection technology to detect more MRSA strains, including the mecC gene, and to avoid false positive results due to mecA dropouts." More accurate detection helps prevent transmission of new MRSA strains and can save healthcare costs by focusing infection prevention resources on those patients who are true MRSA carriers.

The BD MAX MRSA XT assay represents BD's commitment to provide healthcare institutions better assays that detect and prevent healthcare-associated infections (HAIs). Other HAI assays available on the BD MAX System include BD MAX(TM) StaphSR, which detects and differentiates Staphylococcus aureus and MRSA, and BD MAX(TM) Cdiff, for detection of toxigenic Clostridium difficile. These BD MAX(TM) HAI Solutions combine efficiency with the flexibility to perform multiple HAI assays in the same run, allowing hospital laboratories to customize testing in response to current and future challenges in the fight against HAIs.

Read more

Microbiologics Debuts New Molecular Standards Product Line - Helix Elite

Microbiologics, a leading global manufacturer of prepared quality control microorganism products, debuts its first molecular product line, Helix Elite. These molecular standards are intended to facilitate the development, validation, and monitoring of molecular assays. The Helix Elite molecular product line currently includes 13 molecular standards for microorganisms that are difficult to grow or cannot be cultured such as Cryptosporidium and Norovirus. Microbiologics unveiled Helix Elite at the Association for Molecular Pathology’s Annual Meeting in Phoenix, AZ.

Helix Elite is the first product available from Microbiologics’ newly-formed Molecular Products and Services Division, led by Brian Beck, Vice President Molecular Products and Services.  These synthetic standards are developed using a unique patented bioinformatic algorithm that combines the genetic diversity of diagnostic sequences from the target organism. Helix Elite molecular standards can be used as internal or external positive controls in a defined reaction or spiked into matrices and are applicable for a broad range of assays and instruments. According to Beck, “The Helix Elite molecular standards are a safe alternative to using infectious materials that are otherwise hard to access.”

Microbiologics’ CEO Brad Goskowicz commented, “Microbiologics is leveraging its experience as a global provider of microbial cultures and reagents to provide innovative products of the highest quality to support molecular diagnostics.  With the addition of Helix Elite, Microbiologics is now positioned to offer a full-line of controls, from microorganisms and attenuated strains to genomic and synthetic molecular standards.”

About Microbiologics:

Microbiologics manufactures cost‐effective, reliable, and easy-to-use microorganism preparations for quality control testing in microbiology laboratories across multiple disciplines including clinical, food, pharmaceutical and cosmetic, medical device, water and environmental. Microbiologics is an FDA-registered establishment and has received ISO 13485 certification, as well as ISO 17025 and ISO Guide 34 accreditations. Currently, Microbiologics has an international distribution network of over 140 companies supporting the company’s mission to create a safer, healthier world. Learn more about Helix Elite at www.microbiologics.com.

For additional information, please contact Microbiologics or visit their website:

Microbiologics, Inc.
Customer Service
Phone: 320.253.1640
Email: info@microbiologics.com

Read more

IDSA Report Calls for Improved, Rapid Diagnostic Testing

The Infectious Diseases Society of America has called for better diagnostics for infectious diseases, outlining goals that require collaborated efforts between Congress, regulatory bodies, industry, professional societies and clinicians.

In an IDSA Public Policy report, published in Clinical Infectious Diseases, the organization makes several key recommendations, proposing solutions and steps toward improving the availability of diagnostic tests.

“Despite advances in diagnostic technology, there is still an unmet need for better tests to identify the specific cause of infections,” Angela Caliendo, MD, PhD, of the department of medicine at Alpert Medical School of Brown University in Providence, R.I., and lead author of the report, said during a media briefing. “Without simple-to-use, inexpensive rapid tests, physicians may wait days to receive information needed to make management decisions, and often make educated guesses to prescribe therapy in the interim.”

The report, titled “Better Tests, Better Care: Improved Diagnostics for Infectious Diseases,” outlines several areas that would benefit from improved diagnostics. These include: accurate diagnosis and treatment of infections; reducing and improving antibiotic use; and assisting public health experts in identifying new threats and tracking disease outbreaks.

“Patient care could improve if we could quickly identify the bacteria causing an infection such as pneumonia or sepsis,” Caliendo said. “Appropriate antibiotic therapy would be administered from the beginning, rather than starting treatment with broad-spectrum antibiotics.”

The report describes six recommendations to help meet the goal of improving diagnostics for infections:

• Stimulate diagnostics research and development;
• Expedite integration of improved diagnostics tests into patient care;
• Address regulatory challenges to diagnostics research and development;
• Ensure appropriate levels of reimbursement for diagnostic testing;
• Encourage adoption of new tests; and
• Educate health care providers on the use of diagnostics.

“This report introduces a new IDSA initiative and raises the red flag about the paucity of new and rapid tests,” IDSA President Barbara Murray, MD, said during the media briefing. “We hope this report will inform and educate others about the need for and importance of rapid tests, which may be extremely beneficial in tackling the myriad of antibiotic-resistant superbugs.”

Read more

Covance and Pathoquest Collaborate on Next-Gen Sequencing to Detect Viral Contaminants

Covance Inc., one of the world's largest and most comprehensive drug development companies, and Pathoquest, a pioneer in the field of pathogen detection, today announced an exclusive agreement to collaborate in providing next-generation sequencing (NGS) based biosafety assessments. This innovative biosafety testing approach, combined with Covance's regulatory expertise, will provide a flexible testing solution to all biotherapeutic clients and make biologic medicines safer.

This NGS-based platform can detect and identify viral contaminants within biologic compounds, such as monoclonal antibodies or vaccines, throughout the entire lifecycle of the product. Since viral contamination poses a significant potential safety risk to patients, regulatory agencies are increasingly focusing on the use of advanced analytical technologies like NGS for detection of viral contaminants.

"This collaboration will provide Covance clients with a high-quality solution to the critical problem of viral contamination of biologics during development and in released product," said Raymond Kaiser, Ph.D. and Global Vice President of BioPharmaceutical Chemistry, Manufacturing and Control (CMC) Solutions for Covance. "As a cutting-edge company in the field of NGS-based virus identification, Pathoquest's capability dovetails perfectly with our CMC analytical solutions to provide our clients access to the latest technology and patients with safer medications."

"Covance's global footprint and extensive experience in BioCMC development, together with their established in-house biosafety testing capabilities, offer perfect synergies to help clients access our NGS-based adventitious assay globally. In an evolving regulatory environment, we anticipate that NGS will soon become the standard approach in biosafety assessment, and our technology helps clients meet that standard now and well into the future," said Luc Boblet, Ph.D., Co-Founder and CEO of Pathoquest.

With several high-profile instances of viral contamination of commercially released biologic drugs detected by NGS, the industry is increasingly adopting the technology. The NGS solution offered by Covance and Pathoquest overcomes the primary limitation of traditional approaches that only identify a predefined, short list of viruses. In contrast, this new solution provides a universal test for identifying any virus in a single, comprehensive analysis that minimizes false negatives.

Covance and Pathoquest will provide clients with a wide range of options for adventitious virus identification, including a rapid detection protocol for the critical evaluation of major issues within production processes and a more comprehensive approach for development and characterization of cell banks and biological production systems. For small, emerging and virtual biotech companies, which represent a growing and valued segment of Covance's client base, this solution allows them to access state-of-the-art technology early in the development process to increase the value and safety profile of their molecule.

Read more

New Collaboration Aims to Detect More TB Cases in Developing Countries

BD (Becton, Dickinson and Company), a leading global medical technology company, and FIND (Foundation for Innovative New Diagnostics) today announced a feasibility project that will evaluate the potential use of a low-cost, image-based TB screening platform that is currently in development. This platform provides ease-of-use and semi-quantitative automated results that improve accuracy by standardizing LED microscopy and eliminating associated user subjectivity. This diagnostic advancement has the potential to streamline the detection process and detect more TB cases when compared to conventional microscopy and centralized laboratory molecular diagnostic testing methods.

"There is a need for improved TB detection, particularly at the lowest levels of a health system," said Renuka Gadde, Vice President, Global Health, BD. "BD's image-based technology will enable simpler, more accurate detection and will enhance TB detection among HIV-TB co-infected populations where microscopy screening may be inadequate. We believe this new technology will play a key part in reaching the missing millions of patients who currently escape TB diagnosis in health systems."

Detection of TB in patients can be difficult and often requires repeat testing to confirm the Mycobacterium TB bacteria in a clinical specimen. It is even more difficult to detect TB in patients who have weakened immune systems due to HIV/AIDS. Approximately one-third of the estimated 33 million people living with HIV worldwide are infected with TB, and TB is known as a leading cause of death for persons infected with HIV.1 With TB infection rates rising exponentially in countries that are heavily burdened by HIV/AIDS, it is critical to address the risk of TB co-infection in a timely manner.  The new TB screening platform aims to more accurately identify smear negative and otherwise culture positive patients within 10 minutes of running the test.

BD and FIND also announced a collaboration to complete a pricing agreement to provide access to laboratory-use only reagents. These laboratory-use only reagents may be evaluated for potential use by TB laboratories.

BD and FIND are committed to stopping the spread of TB, especially multidrug resistant tuberculosis (MDR-TB).  This deadly form of TB is caused by bacteria that do not respond to isoniazid and rifampicin, two of the most powerful first-line, anti-TB drugs. Second-line drugs are only registered for use to treat MDR-TB when there is resistance to first-line therapy. In 2011, the World Health Organization (WHO) estimated 310,000 MDR-TB new cases annually worldwide.[1] The highest proportions of patients with MDR-TB are in Eastern Europe and central Asia. The WHO estimates that although the number of people detected with rapid diagnostics tests is increasing dramatically, three out of four people estimated to have MDR-TB worldwide are still not detected.[2]

"The bad news is that MDR-TB is a public health crisis - the health sector urgently needs rapid, accurate and affordable diagnostics to help detect the disease and to help preserve the effectiveness of the few drugs that really work - the good news is that this new tool has some real potential to do that," said Catharina Boehme, Chief Executive Officer of FIND.

Read more

First Rapid Test to Detect Both HIV-1 Antigen and HIV-1/2 Antibodies Now Available

Alere Inc., the world's leading provider of point-of- care rapid diagnostic and health information solutions, today announced the immediate U.S. availability of the Alere Determine™ HIV-1/2 Ag/Ab Combo test, the first U.S. Food and Drug Administration (FDA) approved rapid point-of-care test that detects both HIV-1/2 antibodies and the HIV-1 p24 antigen, which can appear days after infection and prior to HIV-1/2 antibodies.

"We're excited to announce the availability of the only fourth generation rapid test that can identify HIV infections in individuals earlier than ever before at the point of care by detecting the free HIV-1 p24 antigen," said Joe Medeiros, Director of Marketing, North America Virology Solutions at Alere. "The availability of the Alere Determine Combo test will contribute measurably to public health by helping HIV-positive individuals to become aware of their HIV status earlier, thereby potentially reducing HIV transmission. Earlier diagnosis can also allow effective treatment to be started without delay."

The Alere Determine HIV-1/2 Ag/Ab Combo test is FDA-approved to be sold in the United States as a CLIA (Clinical Laboratory Improvement Amendments) moderately complex medical device. The test simultaneously detects free HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens. The test can be used by trained professionals in healthcare settings to identify HIV-infected individuals.

Alere Determine HIV 1/2 Ag/Ab Combo is currently available to all health facilities and laboratories that are licensed to conduct tests of moderate complexity under the CLIA program. Alere Determine HIV 1/2 Ag/Ab Combo test is currently undergoing CLIA-waiver studies to demonstrate its ease of use, safety and accuracy. In the fourth quarter of 2013, Alere
anticipates submitting to the FDA its application to categorize Alere Determine HIV 1/2 Ag/Ab Combo as a CLIA-waived test, so it can be made widely available in physician offices and public health settings.

According to the Centers of Disease Control and Prevention (CDC), there are approximately 1.2 million Americans living with HIV, and an estimated 207,000 (18%) whose infections have not been diagnosed. In 2010, the CDC estimated that there were 47,500 newly infected people with the virus in the United States, indicating that HIV remains a serious health problem. HIV testing is essential for healthcare and social services to improve the quality of life and survival for persons who have HIV.

Read more