Quidel Receives CE Mark for Its Sofia® RSV Fluorescent Immunoassay (FIA) Test

Quidel Corporation, a leading provider of diagnostic testing solutions and cellular-based virology assays, announced that it has received the CE Mark for its Sofia RSV FIA for use on the Sofia Analyzer for the rapid detection of respiratory syncytial virus (RSV).

Sofia is the brand name for Quidel's next generation, immunoassay system that was launched earlier this year. The Sofia Analyzer and Sofia RSV FIA combine unique fluorescent chemistry, advanced lateral flow technology, and failure alert and fail-safe systems to ensure a reliable, objective, highly accurate, and rapid diagnostic result. The Sofia system was 510(k) cleared in October of 2011 and received Clinical Laboratory Improvement Amendments (CLIA) waiver by the U.S. FDA in April of 2012.

With the CE Mark, Quidel is now launching its new Sofia RSV FIA in Europe. This effort is an important adjunct to its already-ongoing and very active sales and marketing activities in other parts of the world, including Asia, Africa, and the mid-East. This RSV assay is presently not for sale in the U.S.

"We are very pleased to receive the CE Mark for the Sofia RSV FIA. This product will help healthcare workers quickly detect this potentially severe respiratory disease of infants and young children, a disease which is sometimes confused with influenza. RSV is the third assay for infectious diseases available on the Sofia system and will soon be joined by other tests that are in development, expanding the system's utility and appeal worldwide," said Douglas Bryant, president and chief executive officer of Quidel Corporation.

Tim Stenzel, Quidel's Chief Scientific Officer, added, "RSV can be a severe respiratory illness of young children, and accounts for nearly 45% of all hospitalizations for children under two years of age with lower respiratory tract infections in Europe. This situation is similar in the United States where RSV infection is the most common cause of bronchiolitis and pneumonia in children under one year of age, accounting for approximately 125,000 hospitalizations each year. Given the significant morbidity and mortality associated with this disease, the CDC conducts surveillance for this illness throughout the year across all regions in the United States."

The Sofia RSV FIA uses the Sofia Analyzer, a CLIA-waived instrument that is designed to easily incorporate software upgrades for new analyte-specific algorithms as the Sofia menu of products expands. Sofia Influenza A+B FIA received the CE Mark in August of 2011 and Sofia Strep A FIA received the CE Mark in December of 2011.

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Pathogenica and Life Technologies EMEA Partner to Control Hospital Acquired Infections

Life Technologies announced an exclusive agreement with Pathogenica, Boston, Massachusetts, to co-market and distribute for research use, the Pathogenica HAI (Hospital Acquired Infection) BioDetection Kit on the Ion Torrent PGM™ in Europe, the Middle East and Africa (EMEA). Based on Pathogenica's DxSeq™ technologyand the Ion Torrent™ sequencing platform, the kit enables identification of pathogens with high accuracy, at high specific strain resolution and at a scale that could make hospital-wide testing practical.

"Hospital acquired infections are becoming an increasingly serious health risk for patients and present significant economic issues for hospitals," said Peter Silvester, President, Life Technologies EMEA. "The combination of Pathogenica's technology with the Ion Torrent PGM™ will provide a solution that can help address this problem by enabling hospitals to quickly detect these types of infections with extreme accuracy."

Pathogenica's analysis software provides simple, concise output reports that indicate which species and strains are present and at what levels. These kits are not for use in the diagnosis of hospital patients.

Current methods for detecting causative organisms can take days for results or are limited to a few pathogens. The Pathogenica/Life Technologies HAI solution quickly and cost-effectively identifies not only what species are present in a sample, but also provides high-resolution sequence data that includes strain identity and resistance genes, which is critical information for understanding and containing or preventing HAI outbreaks. Pathogenica's kit can detect more than 12 pathogenic bacteria and 15 resistance gene families in a single assay and up to 12 samples can be tested per sequencing run. Dozens of samples can simultaneously be tested in one day with results in an impressive timeframe of less than 12 hours.

The companies are evaluating an opportunity to pursue CE marking together for use of the kit as an in-vitro diagnostic assay.

"As we enter yet another market with Life Technologies as our partner, it is gratifying that together we are helping to make hospitals safer around the world," said Yemi Adesokan, co-founder and CEO of Pathogenica. "The Ion Torrent[TM]PGM has continued to expand its installed base and is an excellent complement to our technology and our mission of making next-generation sequencing relevant and accessible to clinicians."

Each Pathogenica kit provides reagents for identification of the following pathogens and drug resistance markers per sample: Acinetobacter baumannii, Clostridium difficile, Escherichia coli, Enterococcus faecalis, Enterococcus faecium, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Coagulase negative Staph (S.epidermidis, S.saprophyticus), Staphylococcus aureus, common beta-lactamase resistance genes, mecA, and the vanA gene family. The technology allows for fast modification to incorporate the detection of emerging pathogenic fungi, viruses and resistances.

All products referenced are for Research Use Only. Not intended for diagnostic uses.

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New Influenza Test Offers Labs Advanced Performance and Reliable Results

BD Diagnostics, a segment of BD (Becton, Dickinson and Company), a leading global medical technology company, announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for nasopharyngeal wash, aspirate and swab in transport media specimens on the BD Veritor™ System for Rapid Detection of Flu A+B. This new product is cleared for use in clinical settings.

The new BD Veritor System for Rapid Detection of Flu A+B laboratory kit is specifically configured for testing liquid specimens obtained via nasopharyngeal wash, aspirate or swab in transport media. The system, with proprietary technologies, eliminates the subjective result interpretation of visually read assays and helps deliver an accurate read by providing reliable, objective results on a hand held reader with an easy-to-read digital display. The BD Veritor System for Rapid Detection of Flu A + B has demonstrated proven performance versus polymerase chain reaction tests (PCR). This is the only rapid diagnostic flu test that has been referenced and FDA cleared against this high-sensitivity standard.

"Visually read rapid flu tests have shown variable performance results and are prone to errors when interpreting results," said Tom Polen, President, BD Diagnostics – Diagnostic Systems. "The BD Veritor System provides an advanced rapid diagnostic test for influenza A+B by offering accuracy, consistency, and convenience along with an objective read that laboratorians can trust."

The BD Veritor System utilizes Advanced Particle and Adaptive Read Technologies coupled with a special hand-held reader. The Advanced Particle Technology along with improved chemistries helps increase the sensitivity of the test. The Adaptive Read Technology helps reduce false-positive results by examining and compensating for many of the effects of non-specific binding which improves specificity.

The clinical lab version joins the previously FDA-cleared and CLIA- waived BD Veritor System for Rapid Detection of Flu A+B. This assay for Rapid Detection of Flu A+B on the BD Veritor System represents the first of many planned assays on this new platform.

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Illumina Awarded FDA Contract for Next Generation Sequencing (NGS) Technology to Identify Foodborne Pathogens

Illumina, Inc. today announced it was awarded a contract from the U.S. Food and Drug Administration (FDA) to provide the agency with MiSeq sequencing systems and reagents for conducting whole genome analysis on produce and produce-related environmental Salmonella and shigatoxigenic E. coli isolates. The contract is worth up to $17 million over a period of five years.

The FDA currently has several MiSeq systems already deployed and is building its existing capacity to provide resources and training to enhance whole genome sequencing capabilities as part of a proof-of-concept initiative. More immediately, the agency is looking to collect data that is crucial to source tracking Salmonella that may be involved in future produce-related outbreaks.

Using MiSeq, the FDA’s national and state laboratories, where numerous and diverse enteric pathogens are detected, isolated and processed, will be able to generate high-quality whole genome sequences from historical pathogen collections and from bacteria collected from produce sources across the country. Sequencing data will be uploaded real-time to the National Center for Biotechnology Information (NCBI) curated database, thereby enhancing the database’s power for source tracking queries. This data will serve as early proof-of-concept for rapid networking of resources using a whole genome sequencing based approach to pathogen detection, identification and traceback.

“Illumina applauds the FDA’s commitment to improving the public’s safety from foodborne illness outbreaks, as demonstrated by its decision to further integrate whole genome sequencing into its efforts,” said Christian Henry, SVP and General Manager of Illumina’s Genomic Solutions business. “We are extremely pleased MiSeq was selected as the technology platform for this large-scale initiative. We are well-positioned to deliver on the program’s requirements, based on MiSeq’s rapid turnaround time, unmatched accuracy, and ease-of-use, as well as our proven track record.”

Sequencing provides accurate subtyping and cluster analysis for investigating food-borne outbreaks and traceback to the food or environmental source. However, conventional molecular typing tools lack the resolution for differentiating tightly linked bacterial isolates and provide limited genetic differentiation of certain strains such as Salmonella. MiSeq is ideally suited for screening bacterial pathogens due in part to its speed, simple workflow, high resolution, and accuracy, which enhance the ability to identify close related bacterial isolates.

This project supports FDA’s mission of protecting public health by generating baseline data to identify and remove contaminated produce from the nation’s food supply. Currently Salmonella is the leading cause of food-borne illness in the United States.

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USDA Issues Letter of No Objection for Neogen’s NeoSEEK™ STEC Detection System

Neogen Corporation has announced the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has issued a letter of no objection for the use of Neogen’s NeoSEEK™ pathogen DNA detection method to detect Shiga toxin-producing strains of E. coli (STECs).

The letter of no objection allows the use of the 24-hour NeoSEEK STEC system as a confirmatory method for six STEC serogroups (O26, O45, O103, O111, O121, and O145) and states the NeoSEEK system is comparable to the reference method, FSIS MLG 5B.02, which can take three or more days to achieve a confirmatory result. This allows companies to use the NeoSEEK system to comply with the USDA’s recently implemented regulation that requires the testing of raw beef trim for six new STEC serogroups, in addition to the previously regulated STEC, E. coli O157:H7.

“The letter from the USDA provides further assurance to our customers that our NeoSEEK system performs as designed,” said James Herbert, Neogen’s chairman and CEO. “As worldwide food regulation has evolved to address newly identified threats to our global food supply, such as STECs, Neogen’s test systems have evolved to rapidly and accurately detect those threats. NeoSEEK provides the DNA-definitive test the food industry needs that has been proven to be comparable to the older reference method, yet provides much quicker results.”

Neogen received the USDA’s letter of no objection as a result of extensive studies validating the effectiveness of the NeoSEEK system. The NeoSEEK technology uses mass spectrometry-based multiplexing to determine the genetic composition of bacteria in a food sample, and then compares those results with the known genetic makeup of the target E. coli strains to identify and differentiate the target strains. NeoSEEK provides confirmatory results directly from the enrichment broth, eliminating the need for single colony isolation and allowing for accuracy while delivering confirmatory results more rapidly.

NeoSEEK assays a high number of independent genetic markers to detect and identify pathogens, which provides actionable results much sooner than conventional cultural methods.

Like the better known and widely regulated E. coli O157:H7 strain, these other six E. coli strains are known food safety concerns, and produce Shiga toxins, which are known to cause severe illness.

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Meridian Bioscience Receives FDA Clearance for New Molecular Test: illumigene® Group A Strep

Meridian Bioscience, Inc., Cincinnati, Ohio today announced that it has received FDA clearance for a new molecular diagnostic test for Group A Streptococcus on the illumigene® platform.

Group A Streptococcus is a bacterium commonly found in the human throat or on skin and causes a wide variety of diseases in humans, the most common being acute pharyngitis or strep throat. Group A Streptococcus infections may result in mild illness (e.g. pharyngitis, impetigo) or may lead to invasive, life-threatening illness such as acute rheumatic fever, cellulitis, bacteremia, necrotizing fasciitis, or Streptococcal toxic shock syndrome.

illumigene Group A Strep represents a significant new advancement in healthcare by providing a molecular solution for the detection of Group A Strep pharyngitis. Acute pharyngitis is one of the most frequent illnesses for which pediatricians and other primary care physicians are consulted, with an estimated 15 million visits per year in the United States. Approximately 20-30% of children seeking physician care are diagnosed with Group A Strep pharyngitis. Traditional laboratory diagnosis is performed by rapid antigen testing or throat swab culture. Studies show that culture may miss up to 10% of true positives.

Accurate diagnosis of streptococcal pharyngitis followed by appropriate antibiotic therapy is important for the prevention and control of Group A Strep infections. The illumigene Group A Strep test utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus pyogenes in throat samples. The test procedure is remarkably simple and highly sensitive. It requires no expensive capital equipment. The test relies upon a simple procedure that takes less than one hour. All reagents and disposables are contained in the test kit and can be stored at room temperature. The simplicity of this technology, along with its cost efficiency, make this innovative test ideal for helping in early diagnosis and proper patient management of this common and serious disease.

Donna Mayne, Supervisor of the Microbiology, Serology and Molecular Laboratories at Sacred Heart Hospital in Pensacola, Florida states, "The utilization of GAS molecular testing decreases our turnaround time and offers increased sensitivity."

Rick Eberly, Chief Commercial Officer stated, "illumigene Group A Strep is a significant addition to Meridian's illumigene menu, especially as it offers the advantages of both faster and more accurate strep throat diagnostic results. This test continues the expansion of our illumigene technology, which allows healthcare professionals to implement a sophisticated molecular amplification test that is affordable, quick and easily administered in any lab or hospital setting."

Furthermore, Jack Kraeutler, Chief Executive Officer, stated, "Meridian continues to focus on developing innovative technologies that help reduce the overall costs of healthcare. Our diagnostic tests are specifically developed for faster and more accurate detection and early diagnosis of acute infectious disease-causing pathogens. With illumigene Group A Strep, healthcare providers and patients can get a definitive strep throat diagnosis rapidly. As a result, they can help their patients reduce the risks of Group A Strep transmission and complications which ultimately contributes to decreasing healthcare costs."

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Idaho Technology, Inc. Becomes BioFire Diagnostics, Inc.

Idaho Technology, Inc., today announced it has changed the corporate name to BioFire Diagnostics, Inc. to more accurately reflect its business strategy and strong momentum in the marketplace.

"We are excited to announce our new name to our customers and industry members," said Kirk Ririe, Chief Executive Officer of BioFire Diagnostics. "The new name reflects the passion and energy of the Company and management team, and highlights our expanded presence in the clinical diagnostics market. We have established strong momentum in the diagnostics marketplace and the new branding under BioFire Diagnostics better reflects the markets we serve. We believe we are in an excellent position to continue building our business by driving growth of our broad molecular diagnostic product portfolio."

BioFire Diagnostics will continue to focus on leveraging its novel FilmArray® pathogen detection system to develop multiplex diagnostic tests for various clinical applications. The FilmArray Respiratory Panel (RP) is FDA-cleared for 20 viral and bacterial respiratory pathogens. BioFire now provides the only FDA cleared clinical diagnostic test for 8 of the 20 organisms in its panel. In addition to the FilmArray RP, the Company is developing similar FilmArray panels for pathogen identification in blood culture, gastrointestinal infections, meningitis and much more.

In addition to its enthusiasm around the clinical diagnostics space, BioFire will continue to lead in the development of reliable and sensitive biosurveillance products such as its PCR-based biodetection system RAZOR® EX and the FilmArray BioSurveillance System. About BioFire Diagnostics, Inc.

BioFire Diagnostics, Inc. is a privately held clinical diagnostics company based in Salt Lake City, Utah. The Company manufactures and distributes its proprietary diagnostic respiratory panel, FilmArray RP, which operates on its user-friendly FilmArray system, to hospital-based clinical laboratories in the U.S. and E.U. BioFire is continuing to develop a broader test menu for its FilmArray system, including a blood culture ID panel, gastrointestinal panel, and a meningitis panel. The Company prides itself in a comprehensive understanding of what matters most to its customers, and continues to make great strides to ensure that its products remain reliable, user-friendly, and on the cutting edge of innovation.

The Company also currently holds over 70 patents related to polymerase chain reaction (PCR). The Company has used its extensive patent portfolio to successfully market nearly 200 products to the clinical, research and military markets. BioFire collaborates with various U.S. governmental agencies including the Department of Health and Human Services and the Department of Defense. Additionally, researchers, medical technicians, law enforcement officers, and soldiers in the field use company devices to detect or study disease-causing organisms.

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3M Molecular Detection Assay for Listeria Environmental Testing Receives AOAC-PTM Approval

3M Food Safety announced that it received AOAC-PTM Certification for the 3M™ Molecular Detection Assay Listeria for Environmental Testing (#081203) from the AOAC Research Institute’s Performance Tested MethodsSM Program. About 1,600 cases of listeriosis are reported annually in the United States according to the Centers for Disease Control and Prevention, with some resulting in casualties. A 2011 outbreak linked to cantaloupe infected 147 individuals and was responsible for 33 reported deaths.

Using two unique, innovative technologies – isothermal DNA amplification and bioluminescence detection, the 3M™ Molecular Detection System is a fundamentally different pathogen detection method. Its development was based on customers’ expressed needs for a pathogen detection solution that is faster, simpler and delivers more accurate results. This validation confirms the assay’s ability to monitor the facilities of today’s food processors and follows earlier validations of assays for Salmonella and E. coli O157 (including H7). 3M also offers this 3M Molecular Detection Assay Listeria for the testing of food matrices including produce, meat, seafood, poultry and dairy. Use of this assay for the evaluation of food, is in process as a matrix extension to this current AOAC-PTM.

“Clients value the thorough process used to validate the assays for Salmonella, E. coli O157 (including H7) and Listeria,” said Niki Montgomery, global marketing manager with 3M Food Safety. “Recent outbreaks and recalls due to possible Listeria contamination further highlight the importance of using an AOAC-PTM certified method to detect foodborne pathogens.” The AOAC Research Institute bases certification of methods on independent study results demonstrating that a given method meets its product performance claims as expressed in the product package insert. For the 3M Molecular Detection Assay Listeria PTM study, artificially contaminated surfaces were evaluated using the 3M Molecular Detection System as compared to the appropriate U.S. Food and Drug Administration or U.S. Department of Agriculture Food Safety and Inspection Service reference method. 3M™ Enviro Swabs and 3M™ Sponges were included as collection devices in this study of select surfaces of: stainless steel, plastic and concrete. No statistically significant differences were found in results between the 3M method and the reference methods.

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New Rapid Pathogen ID System Launched to Identify Life Threatening Infections

The molecular diagnostic company AdvanDx, Inc. has just announced the commercial launch of QuickFISH™, a new rapid pathogen identification test for potential life threatening bloodstream infections.

QuickFISH is a new, rapid, molecular diagnostic platform developed by AdvanDx based on its clinically proven proprietary PNA technology. The new platform enables unprecedented (20 minute) species identification of bacteria directly from positive blood cultures allowing the reporting of pathogen identification at the same time as the reporting of Gram stain results.

The platform marks a significant advance in time-to-result and ease-of-use that will help clinicians, hospital pharmacists and clinical microbiologists optimize antibiotic therapy much earlier for patients with bloodstream infections, including septicemia, caused by dangerous bacterial pathogens including Staphylococcus aureus and coagulase-negative staphylococci.

AdvanDx received 510(k) clearance from the U.S. Food and Drug Administration on April 3, 2012 and completed the CE mark requirements as part of the launch process with their U.S. and European Union commercial organizations.

Additional QuickFISH assays for identification of other clinically important microbial species are currently in development for launch in 2012 and 2013 and will provide continued opportunities for AdvanDx and health care providers to work together to improve patient care and reduce overall healthcare costs in the United States and Europe.

“QuickFISH is an innovation that will revolutionize antimicrobial therapy. It provides valuable information rapidly, enabling the prescriber to provide effective antimicrobial therapy more quickly to patients with bloodstream infections, which will help to save lives, decrease the number of hospital days for our patients and allow for cost savings and improve other clinical outcomes,” said Dr. Keith S. Kaye, M.D., M.P.H., Professor of Medicine and Corporate Medical Director, Infection Prevention, Epidemiology and Antimicrobial Stewardship, Detroit Medical Center and Wayne State University.

AdvanDx believes the speed and ease-of-use of QuickFISH within the microbiology lab will provide positive clinical and financial benefit to patients, health care providers and institutions by enabling more targeted antibiotic therapy.

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GenMark Secures FDA Clearance For Respiratory Virus Panel Test

GenMark Diagnostics, Inc., a leading provider of automated, multiplex molecular diagnostic testing systems, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its eSensor® Respiratory Virus Panel for use on its XT-8 system. This test is intended to simultaneously detect and differentiate 14 clinically relevant viruses from patients with influenza-like illness. The eSensor® RVP test has the potential to significantly improve patient care by delivering superior co-infection detection, distinguishing Rhinovirus from Enteroviruses and identifying clinically relevant Adenoviruses.

Compared to other multiplex respiratory viral panels, the eSensor® RVP test delivers superior sensitivity and laboratory efficiency. With rapid processing and minimal hands-on time required from laboratory staff, GenMark's eSensor® RVP test enables clinical laboratories to rapidly report actionable patient results to physicians, while efficiently managing the fluctuating testing workload associated with this seasonal illness.

"The FDA clearance of our eSensor® Respiratory Virus Panel test further demonstrates the capability of our uniquely differentiated electronic detection technology," commented Hany Massarany, GenMark's President and CEO. "The FDA review process, which was both collaborative and thorough, resulted in a 510(k) clearance which supports performance claims that we believe will meet customer needs and expectations, especially with regard to specificity, sensitivity and limits of detection," Mr. Massarany continued.

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Stepping Closer to a New Test for Blood Infection

Scientists at the University of Liverpool are a step closer to providing clinicians with a bedside test for the early diagnosis of the fatal blood infection, sepsis.

Sepsis is a bacterial infection of the blood that causes whole-body inflammation and is the leading cause of death worldwide. Treating it in the early stages reduces the risk, but sepsis is difficult to diagnose until it has taken hold of the body.

Simple Bedside Test

Currently there are no reliable tests to accurately and speedily diagnose the infection, which can lead to delayed or missed diagnosis, resulting in complications or, in severe cases, death. Researchers at Liverpool are developing new rapid detection systems that can analyse indicators of infection using a device at the bedside of a patient.

The team have already discovered a biomarker of the condition, which has proved to be a successful way of detecting the infection at its early stages in patients. The new £1.2 million project, supported by the Technology Strategy Board (TSB), is enabling scientists to work with Liverpool company, Sepsis Limited, to deliver a bedside test that is simple, rapid, and robust in detecting sepsis from a small sample of blood.

Professor Cheng Hock-Toh, from the University’s Institute of Infection and Global Health, said: “Sepsis has a 30 to 50% mortality rate and recognising the infection in its earliest stages is crucial. Now that we have validated the biomarkers of this condition we can focus on miniaturising test systems in the laboratory for point-of-care use at the bedside of patients.”

Also in development, through collaboration between the University, MicroLab Devices in Leeds, and Forsite Diagnostics in York, is a diagnostic tool that can identify a combination of three indicators of bacterial infection from a sample of blood in less than five minutes. Supported through funds from the TSB, it will allow clinicians to distinguish between serious blood infections and other more common bacterial infections in young children.

Dr Enitan Carrol, from the University’s Institute of Translational Medicine, said: “This new diagnostic device, which will combine two separate technologies, will reduce the delays in diagnosis and unnecessary admissions to hospitals, as well as the numbers of deaths from this serious condition. We want to help doctors make the appropriate clinical decision at the bedside, without having to wait for results from a laboratory.”

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bioMérieux Launches its VITEK® Mass Spectrometry Solution for Automated, Ultra Rapid Microorganism Identification for the Pharmaceutical Industry

bioMérieux SA
F-69280 Marcy l'Etoile
France
phone: +33 04 78 87 20 00
email: biopharma@biomerieux.com
website: www.biomerieux-industry.com/ms

VITEK® MS (21CFR Part 11 Compliant) provides microorganism identification in minutes with its specifically developed pharmaceutical database.

bioMérieux, a world leader in the field of in vitro diagnostics, announced today the launch of the VITEK®MS automated identification system for the Pharmaceutical Industry. Using the MALDI-TOF Mass Spectrometry technology and a database developed by bioMérieux for bacterial and fungal identification, VITEK MS provides rapid, robust and accurate identifications. The 21CFR part 11 compliance of the VITEK MS offers the traceability needed by pharmaceutical laboratories.
Accurately identifying potential microbiological contamination of sterile processes and products is essential for pharmaceutical manufacturers. The VITEK MS can reduce this microbial identification time to a few minutes using molecular analysis of proteins from isolated colonies. Other benefits include a very small sample size, minimal analyst hands-on time, and flexibility for use in different kinds of pharmaceutical industry laboratories.

“bioMérieux is pioneering the future of microbial identification in the pharmaceutical industry with VITEK MS,” says Jean-Marc Durano, Corporate Vice President, Industrial Microbiology Unit. “We worked closely with pharmaceutical customers to validate the new solution and it offers an excellent complement to our Pharma Solutions portfolio, which includes: API®, PREVI® Color Gram and VITEK® 2 Compact.”

The VITEK MS system and performance results have already been presented at different conferences such as PDA Microbiology Europe, where it was presented by Sanofi Pasteur in February 2012. The system is now available worldwide for the pharmaceutical industry.

About VITEK MS for the Pharmaceutical Industry

VITEK MS provides ultra rapid results:

Directly deposit the microorganism on the target slide, add the ready-to-use matrix solution and insert slide into the VITEK MS system. Identification results are displayed within minutes.
VITEK MS offers security and traceability:

Not only is VITEK MS 21 CFR Part 11 Compliant, but the VITEK MS includes the VITEK® MS Prep Station, which securely links specimen information with each spot on the target slide. Unique barcodes on the plated media and the VITEK MS target slides offer complete workflow traceability.
VITEK MS provides accurate identification:

The VITEK MS database, which contains a large number of specific microorganisms for the pharmaceutical industry, was developed from multiple regions, countries, sources and environments. In addition, our proprietary algorithm vastly increases the accuracy of identification.
VITEK MS is flexible:

VITEK MS can be integrated into quality control laboratories with either centralized or decentralized workflows by utilizing its unique VITEK MS Prep Station. This flexibility allows multiple users to work in parallel by preparing their own target slides with the capability to identify up to 192 isolates per run.

About Mass Spectrometry

Mass spectrometry (MS) is an analytical technique for determining the elemental composition of a sample. The MS principle consists of ionizing chemical compounds to generate charged molecules and to measure their mass-to-charge ratio. Such molecular “signatures” can be used for rapid bacterial identification (ID) from isolated colonies. The use of mass spectrometry for bacterial ID is especially suitable and cost-efficient for laboratories with high volumes of samples.

About MALDI-TOF

MALDI-TOF technology (Matrix Assisted Laser Desorption Ionization Time-of-Flight) used by VITEK® MS examines the patterns of proteins detected directly from intact bacteria. The sample to be analyzed is mixed with another compound, called a matrix. The mixture is applied to a metal plate and irradiated with a laser. The matrix absorbs the laser light and vaporizes, along with the sample, in the process gaining an electrical charge (ionization). Electric fields then guide the ions into the time of flight mass spectrometer, which separates them according to their mass to charge (m/z) ratio, and ultimately the quantity of each ion is measured. Detection is achieved at the end of the flight tube.
For more information, visit www.biomerieux-industry.com/ms.

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Methodist Hospital Develops New Technology to Rapidly Detect Drug-Resistant TB

Technology developed by scientists at The Methodist Hospital Research Institute could halve the time it takes to diagnose tuberculosis infection, and also tell doctors in a day or two whether the bacteria are drug resistant -- a process that currently takes weeks. Initial tests of the device were recently described in Scientific Reports, a Nature online journal.

"Current TB testing techniques take at least two days, and always require the person to be present," said nanomedical engineer Lidong Qin, Ph.D., the report's principal investigator. "And if a person has ever been exposed to TB, even if they don't have an active TB infection, their test will be positive for infection. In as little as one day, we can identify the species of bacteria by isolating single cells. Our method also distinguishes between past and active infections of tuberculosis."

There were about 11,000 new cases of tuberculosis infection in the U.S. in 2010, with a survival rate of about 95 percent. TB causes about 1.5 million deaths around the world each year.

The new technique uses wafers of elastic silicone polymers that are pocked with tens of thousands of square microscopic wells (50 or 100 micrometers wide and 10 micrometers deep) that isolate cells of Mycobacterium tuberculosis or other Mycobacterium species. Antibodies to the TB protein ESAT-6 are affixed to a glass slide, and the slide is placed over the bacteria-containing wells. The sealed plates are then cultured for 24 to 48 hours at 37 degrees C (human body temperature), which gives the bacteria time to produce their own unique bouquets of active proteins and waste. The wafer and slide are separated. The wells, containing bacterial cells, are photographed microscopically so that bacterial cells can be inspected visually, and the slide, to which TB proteins are now stuck, is sent off for fluoroscopic analysis. If TB is present, the squares covering those wells will appear bright green under UV light.

"It can take weeks of culturing bacteria before one can discriminate the species," Qin said. "By switching the culture platform bulky slants to micron-sized wells -- containers whose volume is one millionth of a vitamin pill -- we can make single TB bacteria detectable in less than one day."

Qin is working on the technology with Xin Ma, M.D., Ph.D., and Yen Nguyen, Ph.D., who also coauthored the Scientific Reports paper. The idea for an improved TB test arose from a chance exchange between Ma and Qin.

"A simple conversation between a clinician and an engineer during a coffee break or lunch can stimulate a new idea," Qin said. "Our microwell technology is one such example."

Traditional TB testing, including methods used by The Methodist Hospital and other medical institutions to screen their employees, requires subjects to receive an under-the-skin injection of a harmless protein produced by Mycobacterium tuberculosis (the injection does not contain live bacteria). Two or three days later, the subject is asked to return for a "reading," during which the injection site is evaluated. If a person has ever been infected by TB, or is currently battling a TB infection, the injection site will appear red and irritated -- a positive reading.

Traditional tests also require subjects to be present twice, whereas the technology developed by Qin, Ma, and Nyugen does not require the patient to be present -- cultures could be sent to a lab hundreds of miles away for analysis, if a patient could not present in person.

To determine whether TB bacteria are resistant to antibiotic drugs, current technology requires a separate test that takes 3-6 weeks to complete. Qin, Ma, and Nyugen, however, have found they can affix to the glass slide additional antibodies to defensive proteins the bacteria produce -- meaning the presence of TB bacteria and whether they are drug resistant can be assessed at the same time. Patients could get the right antibiotic sooner.

Qin said each ELIwell test costs about $10 now. With mass production, however, he said the cost should go down to about $1 per test. Current TB testing technology costs about $4-$6 per person tested.

"The technology is not ready for the market quite yet," Qin said. "We need to test it with patient samples to fully evaluate its potential. We may decide to look at other TB proteins as well, such as CFP-10. If multi-antigens are used, the accuracy of the test could be further improved. And it is very easy to do this given our methods. Our current report, however, shows the technology works."

Qin, Ma, and Nguyen examined Mycobacteria species kansasii and smegmatis, which, like tuberculosis, produce ESAT-6. Microscopic photography of the silicon wafer wells would be used to distinguish whether the bacteria present are members of one of these species.

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Cathedral and Concert Inspire Record-Breaking Biosensor

Scientists are developing an ultrasensitive biosensor into a point-of-care diagnostic platform that they claim can detect and size the smallest virus particle, or potentially a single protein molecule, in a patient’s blood, urine, or saliva sample within minutes. The Whispering Gallery-Mode biosensor developed by researchers at the Polytechnic Institute of New York University (NYU-Poly) derives its name from the Whispering Gallery in the dome of St. Paul’s Cathedral in London, the acoustics of which allows a single whisper to be heard throughout the gallery space.

The amplified biosensor developed by Stephen Arnold, Ph.D., and colleagues effectively measures changes in resonance frequency in a glass sphere as it is contacted by a virus particle or a protein. Experiments reported by Professor Arnold and colleagues showed the platform is capable of detecting MS2, the smallest RNA virus particle known to man, which has a mass of only about 1% that of an influenza virus.

The basic technology underpinning the sensor is thus: Light from a tunable laser is guided down a fiber-optic cable, and its intensity is measured by a detector at the distal end. A small glass sphere is contacted with the fiber, and this diverts the path of the light and causes it to orbit within the sphere. This change is recorded as a resonant dip in transmission through the fiber.

When a virus particle then makes contact with the sphere, it changes the sphere’s properties, causing a detectable shift in resonance frequency. However, the smaller the particle, the harder it becomes to detect and record these changes. This means that previous biosensors based on spherical optical microcavity technology haven’t managed to detect anything smaller than a flu virus because the background noise is just too great, Professor Arnold’s team explains. Large viruses, such as influenza, generate enough of a disturbance to be detected, but smaller particles such as the polio virus, or proteins, require greater sensitivity. To increase sensitivity of such a system further the NYU-Poly team has built in a means to amplify the signal.

They boosted sensitivity to a record-breaking level by effectively pasting gold nanoreceptors onto the resonant microsphere, which act to enhance the surrounding electric field and make even the smallest changes in resonance frequency easier to detect. Each gold nanoreceptor is treated with ligands to which the proteins or viruses bind.

Interestingly, the inspiration for the platform came to professor Arnold during a concert by violinist Itzhak Perlman. “I was watching Perlman play and suddenly I wondered what would happen if a particle of dust landed on one of the strings,” he explains. “The frequency would change slightly, but the shift would be imperceptible. Then I wondered, what if something sticky was on the string that would only respond to certain kinds of dust?”

The NYU-Poly team aims to develop the Whispering Gallery-Mode biosensor technology into a diagnostic and proteomics platform that could be used in the laboratory, field, or doctor’s office to rapidly detect antibodies, virus particles, or even disease-related biomarkers for detecting subtypes of cancer. Professor Arnold et al., describe the biosensor in Applied Physics Letters. Their paper is titled "Taking whispering-gallery mode single virus detection and sizing to the limit."

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In Vitro Diagnostics and Weapons of Mass Destruction

The decision of Idaho Technology Inc. (ITI) to rebrand itself Biofire Diagnostics Inc. on August 28th once again draws attention to the niche diagnostics companies that have emerged since 2001 to support the needs of the Homeland Defense community in response to intelligence-lead biological warfare threats, perceived pandemic disease threats, and the inter-relationship between traditional clinical diagnostics and biodefense.

According to GlobalData's latest insight, the detection and identification of deliberately disseminated pathogens and biological toxins utilize similar technologies to those already used in clinical in vitro diagnostics, such as immunoassay or the Polymerase Chain Reaction (PCR). While there are clearly different specific needs, both the biodefense and clinical diagnostics markets have common requirements.

Dr. Andrew S. Thompson, GlobalData's Senior Research Analyst covering Medical Diagnostics, said: “In recent years, governmental biodefense budgets have seen a reduction in spending by the traditional major players.

“However, recent pronouncements by the US and French governments on the developing situation in Syria, specifically in relation to Syria’s use of weapons of mass destruction – including biological weapons – once again raises the profile of biodefense.”

Biofire Diagnostics is not the only technology company with an eye on both the clinical and biodefense markets. The most recent edition of the Chemical, Biological, Radiological Technology Survey provides a snapshot of the current and future offerings, with the next survey due in 2013.

According to GlobalData, most of the providers are also major participants in the clinical diagnostics market, and many of the products are modifications of existing commercially available products. ‘Traditional’ providers of laboratory and clinical instrumentation continue to secure funding to develop new platforms aimed at a biodefense application. For instance, in August 2012, Luminex was awarded an $11m contract by the Defense Threat Reduction Agency to develop a portable device for the detection of patient bio-markers (DNA and proteins) for Systemic Inflammatory Response Syndrome (SIRS).

Although aimed principally at providing a rapid diagnostic tool for soldiers who have suffered a trauma in the field (e.g. infection by a biological threat agent), there are potential benefits for the general diagnosis of SIRS, and the targeting of relevant therapies.

Identification and verification of stockpiles, as well as measures to protect survey personnel, will likely continue to utilize dual-use diagnostic platform technologies from companies including Biofire and Luminex, says the business intelligence experts.

Dr. Thompson added: “The continued future demand for highly sensitive, high-specificity and reliable biodetection instruments for use in hostile environments is sure to continue to provide benefit to the wider diagnostic community, as well as driving diagnostic platform design to more flexible concepts, where the detection chemistry can be easily changed for different targets.”

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