Bruker Receives FDA Clearance for the MALDI Biotyper Microbial Identification System

Bruker Corporation announced that it has been granted U.S. FDA clearance under Section 510(k) to market its MALDI Biotyper CA System in the United States for the identification of Gram negative bacterial colonies cultured from human specimens.

The MALDI Biotyper CA System includes the bench-top microflex™ MALDI-TOF (matrix-assisted laser desorption ionization time-of-flight) mass spectrometer, software, IVD labeled reagents, a 48-spot MALDI target and a library of microorganism reference spectra. Bruker has conducted a multi-site clinical trial comparing performance of the MALDI Biotyper CA System to 16S ribosomal RNA gene sequencing. The overall accuracy of the MALDI Biotyper CA System was comparable to that of nucleic acid sequencing. FDA clearance of the MALDI Biotyper CA System is the latest achievement in Bruker’s continuous efforts to develop MALDI-TOF mass spectrometry into the most advanced platform for clinical microbiology identification.

In 2009, Bruker launched a MALDI Biotyper system in compliance with the European in vitro diagnostic directive EC/98/79, making the CE-IVD labelled IVD-MALDI Biotyper the first MALDI-TOF based product registered for use in European clinical microbiology laboratories. Since then, Bruker has continued its effort to expand into routine clinical microbiology and other markets throughout the world. Currently the CE-IVD labelled IVD-MALDI Biotyper is available for clinical microbiology routine usage in Europe, as well as in many countries around the world, including Canada, Argentina, Mexico, Colombia and Ecuador in the Americas and in Japan, Hong Kong, Singapore, Malaysia and Taiwan in Asia/Pacific.

Frank Laukien, President and Chief Executive Officer of Bruker Corporation, commented: “We are very excited about this major milestone in our effort to introduce MALDI-TOF mass spectrometry into clinical diagnostics. For the last seven years Bruker has been working on continuous innovation in the field of MALDI-TOF-based microbial identification, bringing the MALDI Biotyper platform into clinical routine laboratories. The MALDI Biotyper has been a success with more than 1,000 systems sold or leased worldwide, which has positively affected the health of many patients. Bruker has initiated a continuing revolution in clinical microbiology towards the MALDI Biotyper as a next-generation identification technique. With clearance by the US FDA to market the MALDI Biotyper CA System, we expand our market reach into the largest clinical market in the world, with expected significant improvements in outcomes and reductions in the cost of healthcare.”

Dr. Robert Jerris, PhD, D (ABMM), the Director of Clinical Microbiology at the Children´s Healthcare of Atlanta pediatric hospital, added: “MALDI-TOF has had a dramatic impact on patient care at Children’s Healthcare of Atlanta. The ability to identify organisms directly from plates - saving at minimum a day over conventional phenotypic tests for many organisms - has impacted therapy, timely infection control and contributed to decrease in healthcare expenditures. Outcome studies have shown such significant positive results that it is predictable to say that this technology will eventually be a staple in clinical microbiology.”

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European LabOnFoil Detects Pathogens

Led by the Basque R&D Alliance IK4, 13 organisations in 8 different countries have been conducting research for three years under the European LabOnFoil project to develop new rapid diagnostic devices.

A patch for detecting cocaine consumption from skin perspiration, a chip to identify pathogens in foods, a device for monitoring colon cancer via a patient's blood, and a sensor to detect environmental contamination via the analysis of marine algae. All four applications have something in common: they all arose from the same European research project, entitled LabOnFoil. This initiative, which ended recently, was set-up to develop rapid and low-cost diagnostics devices that could be adapted to different situations and, in short, offer society new advances to improve quality of life.

The collaboration between the 13 entities from eight European countries who participated in the project has borne fruit in the form of the aforementioned four applications, which have generated new business opportunities in sectors with high added value. As underlined by the project coordinator, Jesús M. Ruano-López, "the consortium's efficient use of resources and good management in general have enabled LabOnFoil to have a significant economic impact".

No wonder some of the applications are now being commercially exploited by different consortium partners. The Spanish company POC Microsolutions, for example, is industrialising one of the prototypes for launch on the market in 2015. For its part, the Irish company Biosensia is launching patches onto the market to detect the presence of drugs, whilst DTU Nanotech (Denmark) is opening a new line of business based on one of these developments.

The LabOnFoil project, which commenced in 2008 and ended in February 2013, had a budget of 7.1 million Euro, and was co-financed by the VII European Framework Programme (EU).

Ruano-López explained that "the goal for all LabOnFoil project partners was none other than the development of devices with a positive social and economic impact. Results have been achieved thanks to our determination to develop compact, reliable devices with added value compared to existing competitors, that is, that could be commercially exploited".

"Teamwork has enabled us to combine consortium members' different specialisations, such as microtechnology, molecular biology, materials, and electronics, to develop much more compact, economical and easier to use diagnostic systems than exist at present. Which ultimately enables drugs, illnesses, contamination, etc. to be identified in very different scenarios, with a very significant commercial impact", stated Ruano-López.

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Rapid Pathogen Identification System Evaluated for Food Industry Testing

PathoGenetix, Inc., a developer of an automated system for bacterial strain typing, and Marshfield Food Safety, LLC, a full service microbiology and chemistry contract testing laboratory, have signed an agreement to evaluate PathoGenetix’s RESOLUTION™ Microbial Genotyping System. Under the agreement, Marshfield will conduct independent testing of the RESOLUTION instrument, assays and database in their corporate laboratory, and provide feedback to PathoGenetix on the speed, utility and ease-of-use of the RESOLUTION System for food industry applications.

The RESOLUTION System provides confirmation for presumptive positive screening tests and identifies molecular serotype and strain type information of foodborne pathogens in five hours. Based on PathoGenetix’s breakthrough Genome Sequence Scanning™ (GSS™) technology, the System isolates and analyzes microbial DNA directly from enriched food samples, without a cultured isolate, to type target bacteria in just five hours, even when multiple serovars are present.

The strain type information provided by GSS is comparable to pulsed field gel electrophoresis (PFGE), the current gold standard for pathogen identification. Unlike PFGE, however, GSS is culture independent, and fully automated from sample preparation to final report. As a result, the RESOLUTION System has the potential to greatly reduce the time, complexity and skill-level required to identify foodborne pathogens in both food industry testing and public health outbreak investigations.

Marshfield Food Safety, LLC, participated in PathoGenetix’s RESOLUTION Customer Experience Program in November to get an initial in-depth and hands-on review of the GSS technology. “We are very excited to evaluate the RESOLUTION System further, and believe that it has the potential to be a very powerful new tool for our customers,” said Marshfield CEO, Roy Radcliff, PhD. “We believe the System can simplify pathogen confirmation and reduce the time required to identify microbial contamination and trace it back to the original source in the production facility.”

Marshfield provides full service microbiology and chemistry testing and food safety risk management services to clients along the food chain from farm to table. In addition to conducting laboratory services for national food producers in its Wisconsin-based corporate laboratory, Marshfield also designs and staffs onsite quality and safety testing laboratories for food producers around the U.S.

“We are extremely excited to begin placing Systems for external evaluations,” said John Czajka, PhD, PathoGenetix’s Vice President of Business Development. “These evaluations will demonstrate the simplicity and utility of the RESOLUTION System, while providing key end-user feedback on how the workflow and user-interface might be improved as the System moves into full commercial production.”

As a part of the collaboration, Marshfield will provide feedback to PathoGenetix that will assist in commercializing the RESOLUTION instrument, database and assays. PathoGenetix also has signed a collaborative agreement with the U.S. Food and Drug Administration (FDA) to evaluate the System for use in public health foodborne illness outbreak investigation and response.

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Urine-Based Assay Diagnoses Chlamydia in 20 Minutes

A rapid and sensitive assay requiring no special equipment can detect Chlamydia trachomatis directly from urine samples with high accuracy, according to a study published in the January issue of the Journal of Molecular Diagnostics.

Katrin Krõlov, from the University of Tartu in Estonia, and colleagues describe an assay to detect C. trachomatis in urine samples using recombinase polymerase amplification of a highly conserved target within the CDS2 gene. The assay was tested on urine samples from 70 patients attending a sexual health clinic and compared with the Roche Cobas Amplicor C. trachomatis assay.

The researchers found that the test had a minimum detection limit of five to 12 pathogens and could detect pathogen directly in urine within 20 minutes. Initial analysis of the assay showed specificity of 100 percent and a sensitivity of 83 percent.

"The whole procedure is fairly simple and does not require specific machinery, making it potentially applicable in point-of-care settings," Krolov and colleagues conclude.

The abstract and full text may be accessed here.

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EMSL Implements the bioMérieux VITEK®MS

bioMérieux,Inc a world leader in the field of in vitro diagnostics, is pleased to announce that EMSL Analytical, a leader in microbiology testing specializing in rapid pathogen detection is adopting the company’s VITEK® MS technology for rapid identification of potentially harmful microorganisms.

VITEK MS, uses MALDI-TOF mass spectrometry technology to identify bacteria, yeast, and mold, offering significant time savings with respect to traditional identification methods, the system was the first to receive de novo FDA clearance for IVD August 21, 2013. It is also extremely sensitive, providing a standard of accuracy above many of the current state-of-the-art techniques.

“We are excited to bring this state of the art technology to EMSL. The VITEK MS gives us the ability to provide microbial identification with unprecedented speed and accuracy for our clients. VITEK MS also aligns with the needs of EMSL’s cGMP Microbiology lab as well as environmental and forensic microbiological capabilities. We look forward to providing our clients with the benefits that the VITEK MS brings,” said Dr. Frasca, President of EMSL LABS.

Bacterial and mold identification are crucial to confirm contaminations and to guide corrective actions in the production of consumable products made by pharmaceutical, cosmetic, and food manufacturers. With 50 years of experience in microbial identification, bioMérieux brings to the customer the benefits of a robust data collection model suited for industry needs. VITEK MS provides fast, flexible, and robust results, and can provide an identification of a microorganism’s genus and species in just a few minutes. As the world leader in microbiology, bioMérieux pairs VITEK MS system with the most comprehensive microbial database specific for industry in the business.

“Reference laboratories today are striving to improve productivity and shorten their time-to-results needed by their customers,” said Pierre-Louis Thiney, Executive Director US Industry for bioMérieux. “Providing a fully integrated, rapid solution for microbial identification is a significant step in providing timely and accurate results to the customer.”

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New Biotechnology Offers Rapid Diagnostics

The revelation of a new optical dimension in nanophotonics offers untapped clinical potential in non-invasive cancer diagnostic kits, rapid pathogen screening for acute infection, and invisible coding for identification of authentic pharmaceuticals.

Lead researchers Yiqing Lu and Dayong Jin from Macquarie University have invented a new generation of nanocrystals, called "τ-Dots".

τ-Dots can be coded in the time dimension in addition to colours, that is, their luminescence lifetimes (τ) can be engineered and assigned to a single nanoparticle.

"This extra dimension offers an exponential boost in the total number of potential combinations, which can be used for multiple medical tasks or diagnoses simultaneously," said Lu.

"These nanocrystals can form combination codes, like barcodes, to form a vast library of distinguishable molecular probes, which can be used for complex diagnostics. Screening tests can more quickly and accurately identify the cause of infection, residue cancers at an early stage, and locate the specific molecular targets for targeted drug therapies. " said ARC Future Fellow Dr Jin.

Co-author, Professor J Paul Robinson from Purdue University said "This toolset is really a paradigm shift for identifying rare events in high-noise environments typical in biological systems such as cancer detection, high throughput screening and also in the biodetection domain."
The τ-Dots also have application in improving the storage capacity and security of data, and can invisibly mark genuine drug products as an anti-counterfeit measure, says Lu.

"Our ability to layer the τ-Dots' lifetimes enables higher density storage than was previously possible. We can also protect the data by codifying the τ-Dots until they are essentially impossible to crack.

"By applying τ-Dots to any surface, we can leave a secret message or mark on any product, which will only be revealed by a specially designed scanner. This has huge potential in confirming the authenticity of any product, from pharmaceutical drugs to medical courier supplies."

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Microchip Aids Rapid Microorganism Identification

Researchers have developed a glass/silicon polymer chip with a microscopically small channel that enables clinicians to rapidly sort microbes using dielectrophoresis, according to findings in a new study.

The goal is to develop a battery-operated, hand-held device using the technology to reduce from days to minutes the amount of time needed to identify and characterize microorganisms, Mark A. Hayes, PhD, associate professor in the department of chemistry and biochemistry at Arizona State University in Tempe, and colleagues reported in Analytical and Bioanalytical Chemistry.

Traditional methods of identifying microorganisms require the time-consuming process of growing cultures from food or infected patients and then sending them out to a laboratory. The novel microchip technology relies on dielectrophoresis, a process that involves applying voltage to bacteria causing them to become trapped at different points along the microchip’s channel based on its molecular and electrical properties.

The technology has successfully distinguished between extremely similar pathogenic and nonpathogenic strains of Escherichia coli serotypes, Hayes and colleagues said.

They injected three E. coli strains into a single microchannel and applied voltage to drive the cells downstream. Geometric features of the channel created an electrical field with different intensity levels at different regions, creating a gradient insular dielectrophoretic force that allowed some cells to pass and trapped others based on phenotype.

“The fact that we can distinguish such similar bacteria has significant implications for doctors and health officials,” Hayes said.

So far, the researchers have only tested pure cultures, but aim to test complex mixtures of particles similar to those found in nature or the human body in the near future.

The next step will be to create cheap, portable devices that could enable point-of-care or field-based analysis, potentially yielding more rapid responses to disease and contamination.

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Rapid TB test Could Be Ready in 18 Months

A new rapid tuberculosis test shortens diagnosis time on one of the world’s deadliest diseases from several weeks to a few hours.

The disease, caused by various strains of mycobacteria, attacks the lungs or other organs and is spread through the air when an individual with active form of TB coughs or sneezes. As much as one-third of the world’s population may be infected with TB and another one percent becomes infected every year. One in ten cases progress to the active disease, which presents symptoms such as a chronic cough, coughing up bloody sputum (mucus), fever, night sweats and weight loss.

If left untreated—a common scenario in developing countries lacking the infrastructure or resources to efficiently screen and follow up with infected patients—a person with active TB has only a 50 percent chance of survival.

Jeffrey Cirillo, professor in the Department of Microbial Pathogenesis and Immunology at Texas A&M Health Science Center (TAMHSC) College of Medicine, and his team have discovered a new method to spot the bacteria that causes TB, a profound advance in point-of-care diagnosis of the disease.

“We’ve identified a fluorescence substrate that reacts with the bacteria,” Cirillo says. “This gives us a very sensitive signal that wouldn’t be possible otherwise.”

Once sputum samples are combined with the reactive substance, a battery-powered, handheld reader is then used to detect any fluorescence and deliver the diagnosis.

“There isn’t a diagnostic tool comparable to this in terms of allowing patients to rapidly determine whether or not they are infected.”

While other TB tests exist, they take several days to produce results. Cirillo’s breakthrough involves using the new substrate to targeting a specific enzyme the bacteria produces as an indicator of the bacteria’s presence. It has not been previously possible to target a specific TB enzyme as a diagnostic for this disease.

The lab is working on developing alternative methods that would enable testing using urine or other types of human tissue, as well as taking a first look at additional bacteria that may be susceptible to this florescent reaction.

“We would like to apply it in all respiratory diseases,” Cirillo says. “The first applications in the next few years will be TB.”

The research team includes GBDbio, a Texas A&M spinout company, and Jianghong Rao at Stanford University. The project, published in Nature: Chemistry, has letters of support from the World Health Organization, Doctors Without Borders, and the Clinton Health Access Initiative. Cirillo is now seeking late-stage funding for the additional testing required to replicate his findings in independent labs, a crucial final step before production and distribution of the test kits can begin.

“We’ve done smaller scale testing in hundreds of samples,” Cirillo says. “To validate for worldwide use, it will require thousands of tests and validation in multiple labs outside our own. Right now, we’re at maybe an 18-month window for this device to be out serving patients.”

The Bill and Melinda Gates Foundation and the Wellcome Trust funded the project.

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Researchers Have Identified a Biomarker for Sepsis in Blood

Researchers at King’s College London have identified a biomarker – a biological ‘fingerprint’ – for sepsis in the blood, and showed it could be possible to diagnose the condition within two hours by screening for this biomarker at a patient’s bedside.

Sepsis (sometimes referred to as ‘blood poisoning’) is a life-threatening condition that arises when the body’s inflammatory response to a bacterial infection injures its own tissues and organs. Costing the NHS over £2billion annually, the condition kills more people than breast and bowel cancer combined (approximately 37,000 a year). Rapid diagnosis and treatment with antibiotics saves lives, but as there are currently no biomarkers in clinical use to enable fast diagnosis, it can take up to two days to analyse samples in the laboratory.

Published in the journal PLOS ONE and funded by both Guy’s and St Thomas’ Charity and the National Institute for Health Research (NIHR) Biomedical Research Centre at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London, this study highlights a possible biomarker for the rapid diagnosis of sepsis. The work was performed in collaboration with Cepheid, developer of the GeneXpert, which is capable of performing rapid molecular detection.

RNA helps decode and regulate DNA. This paper investigated microRNAs, which come in many varieties and influence disease processes. Researchers at King’s and Cepheid, a molecular diagnostics company, took samples of blood from three groups of patients; those with sepsis, patients with other Systemic Inflammatory Response Syndrome (that does not respond to antibiotics), and healthy patients. From the blood samples they were able to amplify small amounts of RNA into large quantities to see which particular microRNAs were increased. By using this method, the team found that a certain group of microRNAs were more active in the sepsis patients than in the other groups, highlighting a potential biomarker for the condition.

The study was replicated with a large group of Swedish patients with severe sepsis, which validated the results. By using this method of screening and analysing the blood in both studies, the researchers were able to diagnose sepsis within two hours, with 86 per cent accuracy.

Professor Graham Lord, Director of the NIHR Biomedical Research Centre at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London, said: “Sepsis is a hidden killer, causing nearly a third of all hospital deaths. Rapid antibiotic treatment for the condition is vital – every minute counts. Yet current diagnostic methods can take up to two days, so an accurate diagnostic test that can be carried out at the patient’s bedside is urgently needed.

“We have for the first time identified a group of biomarkers in the blood that are good indicators of sepsis. We have shown that it is possible to detect these markers by screening a patient’s blood in the ward, a process which can deliver results within two hours. This is an extremely exciting development which has the potential to completely transform the management of this severe disease and save thousands of lives worldwide every year. These are promising early findings, and now we need to test this approach in a large clinical trial.”

Symptoms of sepsis are similar to other types of Systemic Inflammatory Response Syndrome (SIRS), yet only sepsis responds to antibiotics. It is therefore important for clinicians to be able to distinguish sepsis from other types of SIRS as administering antibiotics in non-sepsis cases can add pressure to the development of antibiotic resistance. Professor Lord continued: “Not only would an accurate diagnostic test improve outcomes for patients, but it would contribute to tackling the ongoing problem of antibiotic resistance by allowing clinicians to distinguish between SIRS and sepsis and diagnose these severe conditions more accurately.”

Plans for a randomised clinical trial are underway at King’s College London and Guy’s and St Thomas’ NHS Foundation Trust, part of King’s Health Partners Academic Health Sciences Centre.

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New Diagnostic Test Detects Chlamydia trachomatis in Less Than 20 Minutes

Researchers have developed a new assay for rapid and sensitive detection of Chlamydia trachomatis, the most common sexually transmitted infection (STI) in humans. This procedure takes less than 20 minutes and can be easily performed at the point of care (POC) during the patient's visit, reports The Journal of Molecular Diagnostics.

C. trachomatis affects 5% to 10% of the population and is particularly common in young adults under 25 years. It is a major public health concern due to its prevalence and potential severe long-term consequences. One of the main reasons it is so prevalent is that in the majority of cases (75% of women and 50% of men) there are minimal to no symptoms, and it therefore often goes undiagnosed. Infection is associated with non-gonococcal urethritis in men and several inflammatory reproductive tract syndromes in women such as inflammation of the uterine cervix and pelvic inflammatory disease. Untreated, the infection increases the risk of ectopic pregnancy and is one of the leading causes of female infertility worldwide.

The assay uses recombinase polymerase amplification (RPA), a nucleic acid amplification technique (NAAT), to detect C. trachomatis directly from urine samples. Because the assay's novel approach does not require the purification of total DNA from the urine sample, the need for specialized equipment is eliminated. The procedure is significantly less laborious, less time-consuming, and consequently less expensive. It is relatively simple to perform and could therefore be applied in numerous POC settings.

"The assay enables highly specific C. trachomatis detection with sensitivity levels significantly improved compared to currently available C. trachomatis POC assays," says Ülo Langel, PhD, Professor of Molecular Biotechnology, University of Tartu, Estonia, and Professor of Neurochemistry, Stockholm University, Sweden.

Existing polymerase chain reaction (PCR)-based techniques for testing C. trachomatis are widely applied but are only suitable for use in hospitals with trained staff and expensive machinery. Studies have shown that up to 50% of patients never return to get the diagnostic result or required treatment.

Although several rapid-diagnosis POC tests have already been developed, none offer a comparable sensitivity to hospital-based techniques. Recent independent studies have shown that currently available POC tests have a sensitivity of just 10% to 40%. Initial analysis of the new assay's performance indicated a specificity of 100% and a sensitivity of 83%, evidence of its potential reliability.

"The alarmingly poor performance of the available POC tests for C. trachomatis has limited their wider use, and there is a clear requirement for more sensitive and cost-effective diagnostic platforms. Hence, the need for an applicable on-site test that offers reasonably sensitive detection," concludes Prof. Langel.

TECHNICAL DETAILS OF THE STUDY

Recombinase polymerase amplification (RPA) is a nucleic acid amplification technique (NAAT) – a laboratory technique that involves the in vitro synthesis of many copies of DNA or RNA from one original template. These techniques have revolutionized diagnostic technology. Current technologies that allow the detection of amplification in real time are fast becoming diagnostic industry standards.

C. trachomatis cells contain plasmids (small DNA molecules that are separate from chromosomal DNA) that have a number of coding sequences. For identification and amplification by RPA, researchers selected a gene fragment within a gene (CDS2) that was conserved across sexually transmitted C. trachomatis strains. The assay does not require the purification of total DNA from the urine sample. Heating the sample for five minutes at 90°C is enough to release a sufficient amount of the amplification target to determine whether the pathogen is present. Urine contains polymerase chain reaction (PCR) inhibitors, but up to 5 μl of urine can be added without affecting sensitivity of the RPA, whereas the addition of 10 μl affects amplification efficiency significantly.

The C. trachomatis assay developed here was able to detect at least 50 copies of the CDS2 target. C. trachomatis harbors, on average, between four and ten copies of the plasmid per elementary body depending on the strain and development stage. The lowest detectable amount of the C. trachomatis RPA assay can therefore be translated to 5 to 12 pathogens per reaction and is in the same range as other nucleic acid amplification-based techniques.

The assay was tested on urine samples from 70 patients (51 females and 19 males) attending a sexual health clinic in Estonia. The samples were tested in parallel using RPA and Roche Cobas Amplicor C. trachomatis assays.

Fifty-eight samples tested negative in both assays. As no false negatives were detected, the clinical specificity of the C. trachomatis RPA assay can be estimated at 100%.

Twelve of the samples tested as positive using the Roche assay. Of these, 10 tested positive and two tested negative in the RPA reaction. Based on these results, the clinical sensitivity of the RPA assay can be estimated at 83%.

Of the 12 patients who tested positive, three complained of symptoms. The other nine patients were asymptomatic. Of the 58 C. trachomatis-negative patients, 15 (26%) complained of symptoms that could be associated with C. trachomatis infection. One of these tested positive for N. gonorrhoeae and M. genitalium. Others were diagnosed with bladder inflammation (two patients), bacterial vaginosis (five patients), yeast infection (four patients), or abdominal pain of non-gynecological origins (three patients).

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Whole-Genome Sequencing Accurately identifies Bacteria in Clinical Specimens

Researchers in Denmark have found that using whole-genome sequencing directly on clinical samples identified the bacteria causing urinary tract infections in 18 hours.

“Using conventional methodologies, this would have taken several days to weeks, and even using whole-genome sequencing on cultured bacteria would have taken an extra day,” Frank M. Aarestrup, DVM, PhD, of the Technical University of Denmark, said in a press release.

In the study, the researchers examined 35 random urine samples from patients with suspected UTIs using conventional microbiology, whole-genome sequencing of isolated bacteria and directly sequencing the clinical samples. Using conventional identification, they found 19 different isolates for species identification and antimicrobial susceptibility testing.

When they performed whole-genome sequencing on the 17 isolates made in pure culture, the results confirmed the conventional identification in the cases. In addition, there was agreement between the predicted antimicrobial susceptibility. The researchers also performed whole-genome sequencing on 23 of the urine samples, including the 19 positive samples. In the 17 isolates made in pure culture, the sequencing on the urine samples yielded the same species identification.

“Rapid identification of the causative agent, and of any antibiotic resistance, is crucial to choosing the correct treatment for individual patients,” Aarestrup said. “Choosing the wrong antibiotic will lead to longer infections and, in the worst case, deaths.

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Rapid Identification of the Salmonella Serovars S. enteritidis and S. typhimurium

The U.S. Food and Drug Administration (FDA) has issued the Final Rule “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation”, that requires “shell egg producers to implement measures to prevent SE from contaminating eggs” (74 FR 33030). SE can infect the reproductive tract of chickens and enter shell eggs before the shell is formed. An accurate and sensitive test system is required, because levels of SE in eggs from infected hens are often low. The proposed FDA BAM method to test environmental and egg samples is time-consumptive and takes up to seven days for a negative result. BIOTECON Diagnostics now offers a fast, sensitive and convenient assay for the detection and identification of the Salmonella serovars SE and ST: The foodproof® Salmonella Enteritidis & Typhimurium Detection LyoKit, a lyophilized, pre-aliquoted rapid test for the identification of SE and ST in one assay.

The foodproof® Salmonella Enteritidis & Typhimurium Detection LyoKit is the first multiplex real-time PCR rapid test on the market, which detects SE and ST simultaneously in one single test in less than 24 hours. In combination with the foodproof® StarPrep One Kit for sample preparation, BIOTECON Diagnostics offers a safe, easy-to-use and time-saving solution. Get the accuracy, the ease-of-use and a faster time-to-result with reduced overall testing costs, even with challenging samples.

The rapid assay has been validated with more than 110 SE and ST strains, including the monophasic variant 1,4,[5],12:i:-, in combination with all relevant matrices, e.g. egg shells, chocolate and cheese. For exclusivity more than 550 non-Enteritidis, non-Typhimurium Salmonella strains were successfully tested. With this kit BIOTECON Diagnostics introduces the foodproof® LyoKits Product Series, designed to raise the convenience, sensitivity and safety of the foodproof® kits. The pre-filled reaction mix is lyophilized, and the DNA sample preparation can be added directly to each reaction tube. With less pipetting steps, the risk of cross-contamination has been further reduced. The LyoKits are easy to store at 2 - 8 °C and can be shipped at room temperature. Every LyoKit includes an internal amplification control and the proven Uracil-N-Glycosylase system, which prevents carry-over contamination by prior PCR amplificates. The LyoKits are compatible with nearly all open real-time PCR cyclers based on Hydrolysis Probes.

The foodproof® LyoKits Product Series will be expanded by further parameters; Salmonella, STEC and Listeria monocytogenes are already in the process to be launched. Get the accuracy, the ease-of-use and a faster time-to-result with reduced overall testing costs, even with challenging samples.

About 80% of all Salmonella infections in humans are due to Salmonella enterica subspecies enterica serovar Enteritidis (SE) and Salmonella enterica subspecies enterica serovar Typhimurium (ST), according to the European Food Safety Authority. Salmonellosis in humans is often associated with consumption of poultry, eggs and egg-derived products. Additionally, infections in chickens, turkeys and ducks cause economic loss worldwide with morbidity of up to 85% and a low to moderate mortality. Usually, infected birds are culled or rejected at slaughter.

Because SE and ST are the predominant serovars associated with human disease in most countries and because of the differences in the epidemiology as compared to other Salmonellae, these are often specifically cited in zoonosis control legislation. For example, the EU Regulation 1086/2011 claims, that fresh poultry meat has to be free of SE and ST, including the monophasic Salmonella Typhimurium strain.

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NanoLogix and Saudi Company To Work Together for Distribution of NanoLogix Products in the Arabian Gulf Region

NanoLogix, Inc., an innovator in the rapid detection, identification of live bacteria, and determination of their antibiotic resistance and sensitivity, announces that they are working with Nasaem-Aljazira, a Saudi Arabian company headquartered in Riyadh, to establish exclusive distribution and/or manufacturing of NanoLogix products in Saudi Arabia and the Arabian Gulf region, also known as the Gulf Cooperation Council (GCC) area.

This area offers a large market potential to Nasaem-Aljazira and NanoLogix, with Saudi Arabia being a leader in advanced health care initiatives for its people.

NanoLogix is also in negotiations with groups and companies in Europe, Asia and Africa on additional distribution outlets and manufacturing options.

The Company currently sells and ships its products in the US and to the UK.

In keeping with NanoLogix' policy of continual product improvement, the Company has begun electron beam (e-Beam) processing of the majority of its filled Petri plate and BNP detection kit FlatPacks through the facilities at Synergy HealthAST.

This process was initiated to ensure that our FlatPack preserved Petri plates and BNP kits remain viable throughout their extended shelf life, which in some cases for common agars have now exceeded one year at room temperature and two years in cold storage. These times are in sharp contrast with the 3-4 months of shelf life available with competitor's products and offer a significant economic advantage to customers with limited or no cold storage capacity, or those with dynamic testing and project schedules.

NanoLogix recently added 13 additional product variants that have been in demand by its customers and has improved its ordering procedure, enabling a "mix and match" capability for ordering that allows customers to order up to ten different Flatpack detection products in one single carton.

NanoLogix and researchers at UTHSC Houston are working to finalize development of the Company's new N-Assay detection and identification assay. The original concept for use with one bacteria has expanded to one in which as many as five different pathogens can be rapidly detected, identified, and analyzed for antibiotic sensitivity or resistance on one N-Assay multiwell microplate.

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Molecular Assay for Patient Screening Detects S. aureus and Newly Emerging MRSA Strains Now Available in the US

BD Diagnostics, a segment of BD (Becton, Dickinson and Company), a leading global medical technology company, today announced it has received FDA clearance to market the BD MAX(TM) StaphSR Assay for use on the fully-automated BD MAX(TM) System. The assay, with eXTended Detection Technology, accurately detects Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA directly from nasal swabs, including mecA dropout mutants and new strains of MRSA that may not be detected by other assays.

The BD MAX StaphSR Assay is the first and currently the only commercially-available molecular assay in the United States that detects recently discovered MRSA strains with the mecC gene. Rapid, accurate detection of colonized patients enables effective strategies that can help reduce the risk of surgical-site infections (SSIs), improve patient safety and save healthcare costs.(i,ii)

"Increased accuracy in determining patient colonization with either S. aureus or MRSA can enable clinicians to implement appropriate pre-surgical prophylaxis and direct appropriate utilization of isolation and decolonization," said Dr. Tobi Karchmer, Worldwide Vice President, Medical Affairs, BD Diagnostics. "With results available in approximately two hours compared to two or more days for culture methods, the BD MAX StaphSR Assay provides accurate and timely information to help physicians ensure safe and appropriate management of surgical patients."

SSIs are the most frequent healthcare-associated infection (HAI) in the United States, occurring in about one out of every 50 operations, and constitute the greatest portion of HAI-related costs nationally. SSIs due to MRSA increase hospital length of stay for patients by an average of 23 days and cost more than $40,000 per case to treat.(iii) Nasal carriage of S. aureus, including MRSA, is a well-defined risk factor for subsequent infection in surgical patients. Rapid screening and targeted decolonization decreases SSIs by nearly 60 percent and improves clinical and economic outcomes for surgical patients.(iv,v)

With many commercial assays, SA strains carrying SCCmec where the mecA gene is absent (commonly called "dropout mutants") may be incorrectly detected as MRSA. These false positive results can lead to inappropriate use of vancomycin for surgical prophylaxis and unnecessary, expensive isolation of patients.(vi) MRSA strains with the recently discovered mecC gene account for nearly three percent of all new MRSA cases(vii) but cannot be detected by assays that do not detect that gene.(viii) These false negative results can lead to inappropriate surgical prophylaxis in patients who should receive vancomycin to cover for MRSA and lack of appropriate isolation precautions to prevent transmission in the operating room and during hospitalization.

The BD MAX StaphSR Assay represents an important milestone in BD's commitment to provide healthcare institutions with cutting edge assays to detect and prevent HAIs. Other HAI assays available on the BD MAX System include BD MAX(TM) MRSA for the detection of MRSA DNA and BD MAX(TM) Cdiff for the detection of toxigenic Clostridium difficile DNA. 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.

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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.

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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.

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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.

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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."

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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.

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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.

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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.

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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.

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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.”

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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.

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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.

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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.”

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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."

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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.

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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.

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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

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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.”

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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.

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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.

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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.

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