Wednesday, June 27, 2012

PositiveID Corporation's M-BAND System Featured in Article on $5.7 Billion BioWatch Opportunity


PositiveID Corporation, an emerging growth company and developer of sophisticated airborne bio-threat detection systems for America's homeland defense, today announced the Company and its M-BAND System for biothreat detection are featured in the current issue of Bloomberg Businessweek in an article on the estimated $5.7 billion BioWatch procurement by the U.S. Department of Homeland Security ("DHS"). BioWatch is a nationwide bio-surveillance system designed to detect the intentional release of select aerosolized biological agents.

PositiveID's M-BAND, its Microfluidics-based Bioagent Autonomous Networked Detector, was developed under contract for DHS, and is an early warning system designed to detect the intentional release of aerosolized biological agents. It runs autonomously for up to 30 days between service cycles, continuously analyzing air samples, typically in high-traffic areas, for the detection of bacteria, viruses, and toxins with results in as little as three hours. Results from individual M-BAND instruments are reported via a secure wireless network in real time to give an accurate and up to date status for fielded instruments in aggregate. Designed with a high level of operational flexibility, M-BAND can be remotely set to detect for DNA-based pathogens alone, with or without either RNA-based organisms or toxins, or for all three types of pathogens simultaneously at remotely programmable intervals.

William J. Caragol, Chairman and CEO of PositiveID, said, "We believe we are well positioned to compete for Generation 3 of the BioWatch program and we continue to work toward the expected deployment of our bioaerosol detectors. We are extremely proud of our accomplishments in the development of this system over the last eight years, including, we believe, numerous technology advantages, as we have prepared our M-BAND system for this important program for our homeland defense."

Seegene Introduces the First Real Time Multiplex Quantification Test for Human Papilloma Virus (HPV)


Seegene Inc., a leading developer of multiplex molecular diagnostic technologies and tests, today announced the development and commercialization of the first molecular assay for the detection, genotyping and quantification of nineteen high-risk and nine low-risk genotypes of the Human Papilloma virus (HPV). Seegene's breakthrough new test, QuantPlex(TM) HPV28 Genotyping Assay, will provide physicians with accurate HPV genotypes and quantification for nineteen high-risk and nine low-risk genotypes that are directly associated with cervical, genital area and oropharyngeal cancers. Release of the kit is anticipated for the third quarter of this year.

Persistent infections with specific strains of HPV can lead to the development of malignant lesions, and the direct link between HPV and cervical cancer has been well established. To date over 100 HPV types have been identified, of which approximately 40 are sexually transmissible. HPV types 16 and 18 have been associated with approximately 73% of invasive cervical cancers and approximately 10% of cases studied were co-infections of HPV types.

The plethora of HPV types and the correlation between infection and cancer make accurate HPV testing and typing a critical component of effective and efficient patient care. Multiple studies have shown that the molecular testing for the presence and type of HPV is critical when utilized with cytology, especially for neoplasia grade II or higher (CIN 2+).

Furthermore, quantification of viral burden at the time of testing, and over time, has proven to be critical in the determination of applying the correct treatment for the patient. Studies have consistently shown a link between viral burden and CIN grade along with a linkage between changes in viral burden and cytological abnormalities. In addition, evidence suggests that the determination of viral burden in a lesion can be a valuable prognostic indicator of abnormalities.

Nucleic acid-based methods, direct probe and signal amplification methods, such as PCR, are the most common and most sensitive detection approaches. PCR-based testing for HPV usually include a second post-detection and typing technique, such as solid phase hybridization. Limitations of these methods are either related to the inherent complexity of the systems or the relative long time to a result.

"As a highly multiplexed molecular assays capable of rapidly detecting and quantifying specific infections, our QuantPlex(TM) HPV28 Genotyping Assay will help improve clinical outcomes by providing physicians with the information they need to develop personalized treatments for their patients," said Dr. Jong-Yoon Chun, Founder, CTO and CEO of Seegene.

The QuantPlex(TM) HPV28 Genotyping Assay is based on TOCE(TM)-CCMTA technology, a high multiplex real time quantitative PCR technology that allows the simultaneous detection, differentiation and quantification of up to 20 analytes on an existing 4-color real time instrument. This breakthrough technology can provide new and existing life science companies with a competitive edge in a wide range of molecular testing applications and industry sectors.

See more about the Seegene QuantPlex(TM) HPV28 Genotyping Assay at booth #523 at AACC in Los Angeles July 17 - 19, 2012.

Stratos and nanoMR Partner to Develop Technology for Faster, Cost-Effective Pathogen Detection


Stratos Product Development today announced its partnership with nanoMR to develop instrumentation for its unique Pathogen Capture System (PCS) that can rapidly isolate multiple cell types, including bacteria, directly from blood. nanoMR's PCS will provide substantially faster pathogen identification, enabling the physician to begin appropriate antibiotic therapy sooner and improve patient outcomes while delivering a class-leading user experience for laboratory personnel.

"Stratos' development expertise, combined with nanoMR's chemistry and research, creates an ideal team to deliver an optimal solution for the market," Jim Macemon, VP of Product Development, nanoMR, said. "We have been impressed with Stratos' depth of engineering expertise, and their extensive portfolio in diagnostic instrument and medical device development has been invaluable to our effort."

With proven benchtop results and research in place, nanoMR came to Stratos with the challenge to develop a cost-effective cassette and processing regimen with an input of up to a 10 milliliter blood sample and output of 50 microliters containing purified DNA. Not only does this require superior product development experience and skill, but also an understanding of the complexities of the chemical and biological processes involved and the challenges of high-volume design, manufacturing and production of fluid-filled cartridges.

In addition to developing the instrument, Stratos is performing product requirements definition, hardware and software design with ISO 13485 design controls, and manufacturing strategy and verification activities with output supporting CE certification for clinical trials in Europe.

Stratos will showcase its partnership with nanoMR at the AACC Clinical Lab Expo at the Los Angeles Convention Center, July 17-19, 2012 in booth #322.

Nanosphere Receives FDA Authorization to Market Its Gram-Positive Blood Culture Test


Nanosphere, Inc., a leader in the development and commercialization of advanced molecular diagnostics systems, announced today the U.S. Food and Drug Administration has granted a de novo petition permitting marketing of its Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on the automated sample-to-result Verigene(R) System.

The BC-GP test notably expands Nanosphere's infectious disease test capabilities to include fast detection of bacteria that can cause deadly bloodstream infections, an increasingly recognized health threat.

With a single automated test, the Verigene BC-GP test provides fast genus and species level detection for a broad panel of clinically significant gram-positive bacteria. The BC-GP test also detects several crucial markers for antimicrobial resistance, including the mecA, vanA, and vanB genes, which confer resistance to the antibiotics methicillin/oxacillin and vancomycin. Rapid detection of these antimicrobial resistance markers provides vital information for clinicians to determine the best treatment for bloodstream infections.

"With the BC-GP test, patients suspected of deadly infections can now get a first-ever diagnostic tool for detecting disease-causing bacteria while simultaneously determining antibiotic resistance within the critical timeframe for making and adjusting initial treatment," said William Moffitt, Nanosphere's Chief Executive Officer.

The BC-GP test provides identification of bacteria and antimicrobial resistance genes from gram-positive blood culture bottles within two and a half hours, as compared with current microbiological methods, which can take up to two to three days.

Rapid and accurate identification of bacteria and resistance markers is critical in guiding appropriate antibiotic treatment. Studies show delayed administration of appropriate antibiotics is associated with a 7.6% decrease in survival rate for each hour therapy is delayed. Rapid molecular testing of blood cultures reduces this time, with associated hospital cost savings of up to $21,000 per patient.

The sample-to-result BC-GP test automates the steps of bacterial DNA extraction and target detection on the Verigene System.

The ease-of-use and fast turnaround time of the BC-GP test allow hospitals of any size to benefit from the speed and accuracy of automated molecular testing. In addition to its gram-positive blood culture test, Nanosphere is currently developing a test for gram-negative blood cultures that will provide genus, species, and resistance detection on the same automated platform. These tests are part of a comprehensive infectious disease test menu, including the multiplexed Verigene RV+ respiratory virus test cleared by the FDA in 2011, as well as tests for C. difficile and a panel of enteric bacterial and viral pathogens that Nanosphere plans to submit for FDA clearance in 2012.

About Bloodstream Infections

Septicemia is associated with more than 1.6 million hospitalizations per year in the United States and is the most expensive cause of hospitalization totaling $15.4 billion in aggregate hospital costs. Septicemia occurs when a pathogenic microorganism, usually a bacterium or a fungus, enters the bloodstream and causes an inflammatory immune response. Because bloodstream infections and septicemia are pervasive problems associated with high mortality rates, timely delivery of appropriate treatment is essential.

Bloodstream infections with gram-positive bacteria are often complicated by antimicrobial resistance. The inability to rapidly identify resistant strains of pathogenic bacteria has led to antimicrobial use that is often ineffectual, wasteful, or bears risk of proliferating resistant strains. Rapid identification of both organism and resistance is essential to implementing efficient and appropriate therapy.

Gram-positive bacteria are also a common source of contamination during blood draws. Contaminant species are frequently responsible for false-positive blood cultures that lead to inappropriate antimicrobial use.5 Patients with contaminated blood culture bottles are often presumptively treated for bloodstream infections for several days until the organism can be identified as a contaminant using conventional biochemical methods. Patients with false-positive blood culture results triggered by contaminants have hospitalization costs more than $8,000 higher than patients with true negative blood culture results.6 Due to the large burden of infections and contaminants due to gram-positive bacteria, rapid identification of bacteria isolated from blood cultures is a primary healthcare concern.

Monday, June 25, 2012

Micro Imaging Technology to Receive the First Commercial Production Units of Its MIT 1000


Micro Imaging Technology, Inc. announced that the first commercial units of its Rapid Microbial Identification System will be available by the first week of July 2012 from its Hawthorne, CA-based Manufacturing Partner.

"Although we were unable to meet our 2011 manufacturing goal," stated Jeffrey Nunez, Micro Imaging's newly appointed President and CEO. "We have made tremendous strides in just the past 45 days and are very excited to be now in the production phase. We are working closely with our manufacturing partner and feel confident we will meet the specifications outlined for the first several MIT 1000 units," Nunez continued. MIT contracted with a Hawthorne, CA-based manufacturer in 2010 under an exclusive five-year manufacturing agreement to produce MIT's Rapid Microbial Identification System and received the first pre-production MIT 1000 System in late December 2010. This System, manufactured exclusively for MIT, is a stand-alone, optically-based, software driven system. The MIT 1000 can complete an identifying test in less than five (5) minutes and with a material cost of pennies -- adding further credence to MIT's claims of being able to save thousands of lives and tens of millions of dollars in health care cost with its unique technology.

Furthermore, MIT's Chief Scientist, David Haavig, PhD explains: "In the U.S., around 76 million cases of food- borne illnesses, resulting in 325,000 hospitalizations and 5000 deaths, are estimated to occur each year. The leading cause of these illnesses and deaths are three main strains of bacteria: E. coli, Salmonella, and Listeria. Rapid identification of these disease-causing pathogens in food is critical to the health and safety of all consumers."

The AOAC Research Institute (AOAC RI) awarded the Company in June 2009, Performance Tested Methods SM (PTM) certification for the rapid identification of Listeria. The AOAC RI provides an independent third party evaluation and expert reviews of methods and will award PTM certification to methods that demonstrate performance levels equivalent or better than other certified bacteria identifying methods. The MIT System underwent hundreds of individual tests, including ruggedness and accuracy, to earn AOAC RI's certification for the identification of Listeria.

MIT is a California-based public company that has developed and patented a Microbial Identification System that revolutionizes the pathogenic bacteria diagnostic process and can annually save thousands of lives and tens of millions of dollars in health care costs. The MIT 1000 identifies bacteria in minutes, not days, and at a significant per test cost savings when compared to any other conventional method. It does not rely on chemical or biological agents, conventional processing, fluorescent tags, gas chromatography or DNA analysis. The process requires only clean water and a sample of the unknown bacteria. Revenues for all rapid testing methods exceed $5 billion annually -- with food safety accounting for over $3.5 billion, which is expected to surpass $4.7 billion by 2015 according to BCC Research. In addition, the recently passed "New" U.S. Food Safety Bill is expected to further accelerate the current annual growth rate of 6.6 percent.

NicOx Signs Worldwide Licensing Agreement With Rapid Pathogen Screening, Inc. For Ophthalmic Diagnostics


Rapid Pathogen Screening, Inc. (RPS®) and NicOx S.A. announce that they have entered into a licensing agreement giving NicOx access to RPS®'s innovative diagnostic tests. The agreement grants NicOx worldwide rights to unique point-of-care tests in the ocular field. The first of these tests is AdenoPlus™, which is already authorized for marketing in the United States (US) and in Europe. These tests are based on RPS®'s proprietary technology and enable rapid and accurate in-office diagnosis of specific ocular diseases and conditions.

AdenoPlus™ is an easy-to-use point-of-care diagnostic test that identifies patients with Adenoviral conjunctivitis using a small tear sample. It provides a definitive result in only ten minutes, making the correct diagnosis available at the time of the doctor visit rather than relying on only signs and symptoms or waiting for results from a laboratory. AdenoPlus™, in addition to the US and Europe, is also authorized for marketing in other countries throughout the world. The agreement grants NicOx exclusive rights to commercialize AdenoPlus™ to eye care professionals in the US, as well as full exclusive rights to market AdenoPlus™ in the rest of the world. RPS maintains rights to commercialize these ocular tests to primary and urgent care professionals in the US.

The worldwide licensing agreement also covers two additional diagnostic tests currently in development, one for the combined detection of Adenoviral and allergic conjunctivitis and the other to diagnose ocular herpes. In addition, the agreement grants NicOx an exclusive worldwide option to negotiate an agreement for an additional promising product, based on RPS® meeting certain milestones which include on going external discussions.

"RPS®'s innovative and easy-to-use tests allow practitioners to make a more accurate diagnosis during the office visit, provide appropriate and timely treatment, and reduce healthcare costs associated with spread of disease and unnecessary antibiotic treatment. This collaboration will make RPS® products more easily accessible, allowing for better patient care and improved outcomes," said Terrence O'Brien, MD, Professor of Ophthalmology, Charlotte Breyer Rodgers Distinguished Chair in Ophthalmology, and Director of the Refractive Surgery Service at Bascom Palmer Eye Institute of the Palm Beaches.

NicOx has begun building its own commercial organization in the US and Europe to market AdenoPlus™ and potentially other ophthalmology products, both diagnostic and therapeutic, that it plans to acquire or in-license in the future. The Company expects to launch AdenoPlus™ in the US and in key European markets by the end of 2012.

"RPS®'s innovative range of proprietary diagnostic tests are addressing the growing demand by the global ophthalmic market for fast, accurate tests that are easy to use and can help guide treatment decisions," commented Dr. Gavin Spencer, Executive Vice President, Corporate Development of NicOx. "The direct launch of AdenoPlus will enable us to build the foundation for NicOx's new commercial infrastructure. We continue to look for additional diagnostics and therapeutic assets and we have identified a number of opportunities that will enable us to leverage and optimize our commercial organization."

"NicOx will add significant reach and accelerate the global distribution of RPS®'s ocular products through its growing commercial infrastructure. This strategic alliance actuates a critical element of the RPS® strategy, enabling the Company to further leverage its unique and proprietary technology platform," said Mark D. Myslinski, Chief Executive Officer of RPS®. "This is a significant step in the advancement of the RPS® mission to design, develop, and deliver novel point-of-care diagnostics that substantially improve the health and wellbeing of patients around the world."

Under the agreement, NicOx will pay license and option fees to RPS® as well as royalties and potential additional milestone payments. NicOx will also pay half of the development costs for the two development-stage products, subject to an agreed budget. Source: PR Newswire (http://s.tt/1fl9K).

Wednesday, June 20, 2012

Arizona State University Secures Defense Contract


Arizona State University has been awarded a four-year contract from the Defense Threat Reduction Agency of the U.S. Department of Defense to develop a novel diagnostic technology called immunosignaturing for rapid detection of exposure to infectious disease agents before symptoms occur. This contract, with a cumulative value of $30,718,054, consists of a base period with 12 months of performance, valued at $9,057,732; and one option period with 36 months of performance, valued at $21,660,322.

Early detection saves lives by allowing rapid deployment of treatment and implementation of infection control measures to limit further spread, according to George Poste, chief scientist of the Complex Adaptive Systems Initiative at ASU.

Stephen Albert Johnston, co-director of the Center for Innovations in Medicine at ASU’s Biodesign Institute, will lead the project. Johnston with co-principal investigators Poste and Neal Woodbury, co-director of the Center for Innovations in Medicine, will direct the effort to develop a silicon-chip based technology capable of detecting a broad range of infectious organisms based on their triggering the body to produce highly specific antibodies that are unique to each different infectious disease (the immunosignature).

Although this project seeks to develop a sophisticated and highly sensitive detection system to protect military personnel against bioterrorism, it is anticipated that immunosignature profiling will be equally valuable in creating a major advance in rapid detection of infectious and other disease in conventional medical settings.

Poste, a Regents' Professor and Del E. Webb Chair in Health Innovation, founded the Biodesign Institute at ASU before moving to establish the Complex Adaptive Systems Initiative, a research focus of the Office of Knowledge Enterprise Development.

Johnston is a professor in the ASU School of Life Sciences and with Woodbury co-directs the Center for Innovations in Medicine, which is bringing together the multidisciplinary scientific teams to develop the immunosignature diagnostic technology as well as a prophylactic cancer vaccine and new classes of therapeutics and anti-infectives.

Woodbury is a professor in ASU’s Department of Chemistry and Biochemistry in the College of Liberal Arts and Sciences and a senior scientist in ASU’s Global Institute of Sustainability. In addition to co-directing the Center for Innovations in Medicine, he leads research efforts to develop molecular devices and nanoscale hybrid electronics as miniaturized sensors for use in national security, medicine, environmental monitoring and remediation, and agriculture.

“Our success in securing this federal contract, one of the largest in ASU’s history, is a compelling validation of the strength of our research faculty and our growing track record in innovation and technology,” said Sethuraman “Panch” Panchanathan, senior vice president of Knowledge Enterprise Development.

Tuesday, June 19, 2012

InstantLabs' Salmonella Species Food Safety Test Kit Awarded Performance-Tested Methods(SM) Certification from AOAC


InstantLabs Medical Diagnostics Corporation (InstantLabs®), developer of the portable Hunter Accelerated Real-Time PCR® system, today announced that its Salmonella Species Food Safety Kit has been certified as AOAC Performance-Tested(SM) (AOAC PTM Cert. No. 031202) by the AOAC Research Institute (AOAC-RI) across four key food matrices. The kit has been certified for the identification of Salmonella in foods that are among the most common carriers of the potentially lethal foodborne pathogen; whole chicken, ground chicken, ground beef and lettuce. The Company's Salmonella Food Safety Kit previously received PTM certification for the detection of Salmonella in grains (see April 3, 2012 news release). The award follows independent laboratory studies conducted by Food Safety Net Services (FSNS). The AOAC Performance Tested(SM) certification mark is widely recognized by a variety of organizations and government agencies and is awarded to products that have passed unbiased and rigorous evaluation.

"The use of our Salmonella assay and Hunter Real-Time PCR® system allows poultry and beef processors and produce growers to confidently conduct gold-standard food safety testing at their own facilities, rather than sending samples out to external labs for analysis," said Steven Guterman, Chief Executive Officer of InstantLabs. "We are pleased to offer this new level of portability and efficiency to testing for Salmonella and additional pathogens such as Listeria monocytogenes."

Salmonella is a genus of bacteria that are a major cause of foodborne illnesses throughout the world. The bacteria are generally transmitted to humans through the consumption of contaminated food, thus improved detection of contaminated food can reduce the incidence of illness. Salmonellosis constitutes a major public health burden and represents a significant cost in many countries. According to the U.S. Centers for Disease Control and Prevention, Salmonella ranks first among pathogens resulting in domestically acquired foodborne illness as well as death. Millions of cases are reported worldwide every year and the disease is responsible for the loss of thousands of lives.

InstantLabs' Salmonella Species Test Kit, designed for use at the point of need, aims to improve the process for detection of the relevant dangerous bacteria in food products. The assay enables the rapid and accurate detection of certain Salmonella serotypes. The test kit is available to the food industry and import/export organizations worldwide, for whom the ability to deliver the highest quality food products in the shortest possible window of time is crucial to public health and overall success of the organization. In addition to its Salmonella Species Test Kit, InstantLabs has food safety test kits available for Listeria species, Listeria monocytogenes, E. coli 0157 and porcine DNA detection. A complete E. coli test kit that addresses the new USDA FSIS regulations will be available shortly.

Today's testing methods for dangerous and unintended organisms in food products do not routinely take advantage of gold-standard real-time PCR technology. The use of this technology has been limited by barriers including the need for specialized staff, space requirements, complexity, time and cost. InstantLabs removes these barriers with its fully-integrated, compact and affordable Hunter Accelerated-PCR system, requiring only minimal space and basic training to enable real-time PCR testing at the points-of-need. This innovative system increases efficiency while assuring food safety.

T2 Biosystems Presents Data on Novel Method for Endotoxin Detection at ASM 2012


T2 Biosystems, a company developing direct detection products enabling superior diagnostics, today announced the presentation of data on endotoxin detection at the American Society for Microbiology General Meeting, June 16-19, 2012, in San Francisco, CA. The T2Endotoxin assay is a novel method to screen injectable drugs and medical devices for the presence of endotoxins that are produced by gram negative bacteria or fungi, combining the standard Limulus Amoebocyte Lysate (LAL) reagent with Company's T2MR technology. LAL forms a gel in response to the presence of endotoxin and changes in LAL are directly measured by T2MR, similar to the T2Hemostasis application for coagulation and platelet disorders. The data presented at ASM demonstrate that the T2Endotoxin assay provided higher sensitivity, faster detection and lower reagent consumption when compared with commercially available assays.

"The T2Endotoxin assay extends the reach of T2MR detection to the screening of injectable drugs and medical devices for the presence of endotoxin, which is produced by gram negative bacteria and fungi, a field where the current methods rely on decades-old technology," said John McDonough, CEO, T2 Biosystems. "T2Endotoxin enables rapid and ultrasensitive detection of endotoxin, with reduced reagent consumption, delivering many of the same advantages that T2 Biosystems brings to molecular and hemostasis assays. The addition of T2Endotoxin to the range of applications enabled by T2MR demonstrates the versatility of our platform and its ability to solve diverse analytic problems."

The FDA requires that injectable drugs and medical devices are screened for endotoxin, which is produced by gram negative bacteria or fungi. The Limulus Amoebocyte Lysate (LAL) reagent is widely used for its ability to form a gel in the presence of endotoxin, resulting in a highly sensitive detection method. The T2Endotoxin assay utilizes T2MR technology to sense the formation of the LAL gel, similar to blood clotting, which enables higher sensitivity, faster detection and lower reagent consumption.

In the presentation entitled "Rapid ultrasensitive method for endotoxin detection utilizing T2MR and LAL test reagents", the T2Endotoxin assay was compared with two commercially available turbidimetric LAL assays. Dose response curves were generated for 0 -- 100 EU/mL endotoxin levels and the T2Endotoxin assay demonstrated a sensitivity of 0.0001 EU/mL with a turn-around time of 37 min. When compared to the turbidimetric LAL endotoxin test, detection times were reduced greater-than or equal to 50%, sensitivity improved by 100x and per test reagent consumption was lowered by 80%. Correlation plots for endotoxin level vs. clotting time show excellent correlation with R2 greater-than or equal to 0.98. Similar results were observed for LAL detection of 1,3-B-D-Glucan.

Session Title: New Biotechnology Date: Monday, June 18, 2012, 10:45 am -- 12:30 pm PT Abstract Title: Rapid ultrasensitive method for endotoxin detection utilizing T2MR and LAL test reagents Authors: S. Papkov, T. Lowery Poster Board Number: 1459.

Bruker and the CDC Special Bacteriology Reference Laboratory Announce a Collaboration for Mass Spectrometry-based Microbial Identification


At the 112th General Meeting of the American Society of Microbiology (ASM) in San Francisco, Bruker announces a new collaboration with the Special Bacteriology Reference Laboratory (SBRL) of the U.S. Centers for Disease Control and Prevention (CDC).

The SBRL receives approximately 800 isolates of rare and unusual bacteria from U.S. public health laboratories (PHLs) each year for identification. SBRL maintains a culture collection of over 90,000 isolates that have been received over the past 60 years. Currently, SBRL uses a polyphasic approach to identify unusual bacteria, including both traditional microbiological and molecular testing. Traditional biochemical tests may take weeks to complete. Molecular methods, i.e. 16S rRNA gene sequencing, are more rapid, but the public sequence databases may be incomplete and contain erroneous sequences.

MALDI-TOF testing can be completed in hours and therefore has the potential to produce more rapid results than traditional microbiological testing methods. The goals of this announced collaboration include: validation and expansion of the Bruker MALDI Biotyper database of protein fingerprint profiles for identification of unusual bacterial pathogens; evaluation of the use of the Bruker MALDI Biotyper as a replacement for or in conjunction with traditional biochemical testing in order to decrease the time needed for accurate identification of bacteria.

During the collaboration period of one year, each bacterial isolate received by SBRL will be tested using the MALDI Biotyper, traditional phenotypic and 16S ribosomal RNA gene sequencing to validate the results. In addition, type strains of known bacteria will be tested by the three methods. MALDI-TOF will be evaluated for accuracy, reproducibility, and ease of use. Data will be analyzed to determine the value of adding MALDI-TOF to the SBRL testing algorithm.

This research collaboration will enhance the MALDI Biotyper database as well as determine if the MALDI-TOF platform can complement the other testing methods currently used by SBRL and the US PHLs for bacterial identification.

Dr. Gongyi Shi, Director of Scientific Affairs in the Microbiology business of Bruker Daltonics, commented: "We are very excited to establish this collaboration with CDC's Special Bacteriology Reference Laboratory. The MALDI Biotyper has been demonstrated to have superior performance, compared to classical identification methods, for common bacteria representing roughly 95% of the isolates in most clinical microbiology laboratories. With SBRL's worldwide acknowledged expertise in the field and large collection of bacteria, especially those rare and unusual bacteria, we will further improve the coverage of the MALDI Biotyper reference library. Over time, this will allow us to provide an even better solution to our customers."

Bruker and JMI Laboratories Announce a Collaboration for Mass Spectrometry-based Microbial Identification of Fungi


At the 112th General Meeting of the American Society of Microbiology (ASM) in San Francisco, Bruker announces a new collaboration with JMI Laboratories in the field of fungal identification by proteomics fingerprinting. JMI Laboratories is applying the Bruker MALDI Biotyper(TM) to a wide variety of international antimicrobial resistance surveillance studies utilizing the SENTRY Program platform (>300 sites in more than 40 countries and six continents). Among these programs, comprehensive sampling of invasive fungal infections involves nearly 2,000 samples of yeast and moulds, each requiring the highest quality of identifications, and currently requiring gene amplification and sequencing. The Bruker MALDI Biotyper will streamline reference-quality identifications via its rapidly evolving library of clinically important fungi.

Invasive fungal infections are associated with high morbidity and mortality while prompt diagnosis can result in more optimized therapy reducing both mortality and costs of treatment. Current methods for identification of fungi include biochemical, phenotypic, microscopic and molecular methods. Numerous peer-reviewed studies have examined the capabilities of the MALDI Biotyper for fungal identification and Bruker recently launched a separate RUO library of filamentous fungi at ECCMID 2012. MALDI Biotyper testing can be completed in hours and therefore has the potential to produce more rapid results than traditional microbiological testing methods.

The goals of this collaboration include the validation and expansion of the MALDI Biotyper database of protein fingerprint profiles for identification of unusual filamentous fungi, and the expansion of protein fingerprint profiles for identification of unusual yeast species. It therefore will enhance the MALDI Biotyper database as well as determine if the Bruker MALDI Biotyper platform can partially or fully replace the laborious traditional biochemical testing currently used by JMI Laboratories.

Dr. Mariana Castanheira, research scientist at JMI Laboratories and speaking for Professors M.A. Pfaller and R.N. Jones stated: "Contemporary understanding of emerging resistances among antifungal agents requires companion use of reference susceptibility test methods such as CLSI and EUCAST and molecular-level reference-quality organism identifications. The Bruker MALDI Biotyper provides us with an evolving degree of species identification certainty and processing value."

George Goedesky, Executive Director of Microbiology Business Development at Bruker Daltonics commented: "We are very excited to establish the collaboration with JMI Laboratories in the field of fungal identification. Compared to classical identification methods, the MALDI Biotyper has been demonstrated to have a superior performance for common yeast representing roughly 95% of the isolates in most clinical microbiology laboratories. With JMI's acknowledged expertise in the field and large collection of sequenced fungal isolates, especially rare and unusual yeast and moulds, we will even further improve the coverage of the MALDI Biotyper reference library for this very challenging organism group."

Monday, June 18, 2012

Cepheid Welcomes UNITAID Commitment To Broaden Access To "Ground-Breaking" Xpert® MTB/RIF


Cepheid welcomed UNITAID's announcement that it has approved funding of $30 million to scale up access to the "ground-breaking" Xpert MTB/RIF in high burden developing countries (HBDC). According to UNITAID, the funds will be used to roll out Xpert-based programs in around 20 countries, in addition to supporting a buy-down of the price of each Xpert MTB/RIF cartridge from $17 currently to around $10.

"We are honored that our innovative GeneXpert® system and Xpert MTB/RIF test are increasingly viewed as integral elements of global programs to combat tuberculosis, and we applaud the ongoing commitment of UNITAID and others to tackle a disease that is still responsible for more than a million deaths a year," said John Bishop, Cepheid's Chief Executive Officer. "While discussions with UNITAID, USAID and the Bill and Melinda Gates Foundation are ongoing at this time and the final agreement is not yet completed, we believe that all parties are committed to working together to enable HBDC programs to access the test at around $10, which should accelerate adoption in the countries where it is most needed."

Cepheid's Xpert MTB/RIF test was endorsed by the World Health Organization in late 2010, and TB programs in more than 61 of 145 eligible countries have since adopted, or are trialing, the test. As the only accurate, easy-to-use and rapid diagnostic available, Xpert MTB/RIF delivers the potential to diagnose both TB and multidrug-resistant (MDR) TB in 90 minutes, which should enable patients to receive the correct treatment more quickly, and reduce the effects of the disease on entire communities.

Team Developing Network Biosystems MDx Platform for Biothreat Testing Under Five-Year NIH Grant


Researchers from Children's Hospital Oakland Research Institute, Emory University, and Network Biosystems have been awarded a five-year grant from the National Institutes of Health to develop an assay for NetBio's integrated molecular testing system that will identify the biothreat pathogen Chlamydia psittaci and distinguish it from similar non-biothreat pathogenic organisms.

The grant, which is worth $1.2 million in its first year, marks the team's third NIH-funded project to help advance commercialization of NetBio's technology platform, called Genebench. The other two grants have covered the development of rapid, point-of-care diagnostics for Neisseria gonorrhoeae and Chlamydia trachomatis.

Deborah Dean, a researcher at Children's Hospital Oakland Research Institute, is principal investigator on the new grant, which is being administered by the National Institute of Allergy and Infectious Diseases. Additional PIs include Timothy Read, director of the Emory Georgia Research Alliance Genomics Center; and Richard Selden, executive chairman and chief scientific officer of NetBio.

According to recently published grant information, the researchers are developing the C. psittaci assay in response to "an urgent need to develop rapid sample-to-answer clinic- and field-deployable diagnostics for NIAID Category A, B, and C biothreat pathogens to protect both military and civilian populations."

The specific goal of the grant is to advance and validate NetBio's Genebench to identify Category B pathogen C. psittaci, which causes life-threatening respiratory diseases and has historically been a focus of bioweapons development as well as being a vastly understudied pathogen, the researchers wrote in their grant abstract.

The team also aims to detect non-biothreat pathogens that can cause pneumonia and are often confused with biothreat agents in clinical presentation. These pathogens include C. trachomatis, C. pneumoniae, Mycoplasma pneumonia, and Legionella pneumophila.

The researchers cited the original biodefense RFA assertion that medical diagnostics that can rapidly distinguish whether an individual is infected with a biological threat agent or a common infection with similar, generalized symptoms are of high priority.

There are currently few or no commercial diagnostics for these pathogens in the US, the researchers noted.

NetBio has been developing Genebench for several years. The platform uses core microfluidic electrophoresis and Sanger sequencing technology originally developed in partnership with Shimadzu; and also features proprietary nucleic acid sample prep, multiplexed PCR, laser detection, and integrated analysis software.

According to the scientists, the platform is a ruggedized instrument that accepts a biochip set that has been shown in preliminary studies to purify genomic DNA from clinical samples, amplify and electrophoretically separate it, and laser-detect and type C. trachomatis in about one hour from DNA purification to detection.

Under the NIAID grant, the scientists plan to sequence representative C. psittaci biothreat and non-biothreat atypical respiratory pathogens for robust primer selection; modify the biochip set to purify genomic DNA from human clinical nasopharyngeal swab and sputum samples; and use a primer-selection pipeline developed in Read's lab to identify primers for differentiating biothreat and non-biothreat atypical respiratory pathogens based on comparative genomics of available genomes and those sequenced during the course of the project.

The team will then use the primers to develop a multiplexed DNA amplification assay to distinguish each pathogen; and will evaluate the sensitivity, specificity, and positive and negative predictive value of the assay using spiked samples and clinical nasopharyngeal swabs and sputum samples, comparing the test to the few available commercial nucleic acid amplification tests for the target organisms and to highly sensitive in-house RT-PCR assays.

Eventually, the group plans to enter the assay into clinical trials and submit it for US Food and Drug Administration approval.

"A future goal will be to expand the assay to other biothreat respiratory pathogens," the researchers wrote. "We envision that the NetBio sample-to-answer assay will be used in ERs, MD offices, clinics, military facilities, hospitals, and the field to advance our understanding of the epidemiology of atypical respiratory diseases and best treatment strategies, which will inform biothreat preparedness."

Broadly used, the diagnostic will also be able to detect patients with common and biothreat infections, enabling early identification of an attack and rapid treatment of infected military and civilian populations.

In March, NetBio secured $1 million for the first year of a three-year, Phase II Small Business Innovation Research grant from NIH to continue developing Genebench for diagnosing and differentiating C. trachomatis strains, work that began in 2009. And in 2011, the company won $300,000 from NIAID to develop the platform for gonorrhea diagnosis.

NetBio's Selden said in March that the company is actually developing two versions of Genebench: one that will use electrophoretic separation and laser detection to identify multiple amplified targets; and one that will use integrated Sanger sequencing for detection. Both platforms would integrate similar sample prep and amplification steps.

Both systems are being designed for use at the point of care by non-technical users.

NetBio is also currently field testing a human forensic ID system based on the same core technology, which it plans to launch commercially later this year.

A Cheap, Fast, Portable Way to Diagnose Disease in the Developing World


When biomedical engineer Rick Haselton visited New Delhi’s largest public hospital last year, he saw glaring inefficiencies. One of the biggest: Patients were traveling great distances and staying for days just to get routine blood tests for infection. They had no choice, since many outlying regions lacked well-equipped reference labs and tools to purify samples. But if remote clinics could handle the testing, Haselton thought, then the hospital could focus on the sick while the rest stayed home.

The solution, developed by Haselton and colleagues at Vanderbilt University, was the extractionator, a tool that keeps body fluids sterile while tiny magnets extract disease biomarkers, like proteins or bits of DNA, that can be the telltale sign of an infection. To diagnose malaria, for instance, a blood sample is fed into a closed plastic tube filled with millions of tiny magnetic beads coated with nickel. Nickel chemically binds to a protein produced by the malaria parasite, called histidine-rich protein 2. Once the protein attaches to the beads, another larger magnet slides along the outside of the tube, dragging the combo through a series of chambers. One chamber washes contaminants from the beads; another contains a salt that binds to nickel, causing the biomarker to detach. Then researchers put the purified sample onto a cheap, rapid diagnostic chip. The chip detects the telltale protein, signaling a positive result for malaria.

Haselton plans to identify other pathogens by coating the beads with substances that bind to other biomarkers. Silica, for instance, picks up bits of DNA that can be used to diagnose tuberculosis. The tool could also provide an inexpensive way to test drinking water.

Seegene Introduces the Industry's First Real-Time Multiplex Quantification Assay for Respiratory Diseases


Seegene Inc., a leading developer of multiplex molecular diagnostic technologies and tests, today announced the development of a new molecular assay for the quantification of twenty-one respiratory viral pathogens associated with respiratory disease. QuantPlex RV-16 Assay will give physicians the specific information needed to guide patient treatment decisions, and answer questions that previously have gone unasked and / or unanswered.

Acute respiratory disease is a serious source of infection around the world. The majority of respiratory infections (approximately 80%) are viral in nature. Within the pediatric population, respiratory viral infections account for a considerable proportion of emergency room visits. Accurate and reliable detection and differentiation of these respiratory viral pathogens is needed to assess and treat a patient's particular disease state.

Conventional detection methods for respiratory viral pathogen detection include rapid point-of-care immunoassays and cell culture in combination with direct immunofluorescence assays. With the 2009 H1N1 pandemic, nucleic acid detection methods have started to become the accepted standard for the diagnosis of respiratory viral infections. Comparative studies have shown that for the detection of respiratory viruses, real-time Reverse Transcriptase -- Polymerase chain Reaction (RT-PCR) is significantly more sensitive and specific than certain conventional detection methods. Current commercially available RT-PCR detection assays for respiratory viruses, however, can only provide qualitative information.

These qualitative real-time RT-PCR viral respiratory assays are still limited in their ability to discriminate between current infections versus the shedding of low concentrations of virus from previous infections. This inability to discriminate infections also limits physicians' ability to guide the treatment of co-infections.

In contrast, a quantitative real-time RT-PCR respiratory viral assay provides both a qualitative answer, as well as quantitative information concerning each analyte detected. The advantages of a quantitative real-time RT-PCR respiratory viral assay is that it permits the assessment of pathogen load at a given point in time, facilitates the monitoring of response to treatment, and offers the ability to determine the dynamics of the viruses proliferation.

Studies have shown that the virus type and viral load can influence the clinical characteristics of an infection. In addition, studies have shown that viral single infections and co-infections as well as viral load contribute to disease severity in children with respiratory tract infections. Studies have also shown that under specific conditions clinical improvement is associated in respiratory viral infections with a reduction in viral burden.

Furthermore, quantitative tests can aid in the study of a respiratory viral pathogenesis, aid the development of vaccines, assist in the development of treatment strategies, and can facilitate investigations into the significance of respiratory viral infections when there are singular viral or multiple viral infections involved.

Seegene's breakthrough technology is able to quantify multiple targets in a multiplexed molecular real-time PCR format. The QuantPlex RV-16 Assay can detect, differentiate and provide quantitative information for adenovirus, influenza A and B, parainfluenza virus types 1/2/3/4, rhinovirus types A/B/C, respiratory syncytial viruses A and B, bocavirus 1/2/3/4, metapneumovirus, coronavirus types 229E, NL63, OC43 and enterovirus from a single sample, all in real-time.

"The QuantPlex RV-16 Assay represents a new class of quantitative molecular tests that are multiplexed. Multiplex Quantification of viral load by real-time PCR will facilitate a better understanding of viral pathogenesis and will provide information to allow true patient specific personalized care," said Dr. Jong-Yoon Chun, Founder, CTO and CEO of Seegene. "Moreover, respiratory viral load quantification contributes to the rapidly growing field of diagnostic molecular virology, as well as advances the interpretation of real-time PCR results in various clinical contexts. Using these types of tests, clinicians will be able to expand the questions that can be asked about a patient's illness, thereby enhancing the physicians' ability to provide accurate and data driven decisions for their patients."

The QuantPlex RV-16 Assay is based on Seegene's proprietary TOCE-CCMTA technology, a High Multiplex real-time quantitative PCR technology that enables the simultaneous detection, differentiation and quantification of up to 20 analytes on an existing 4-color real-time instrument. This breakthrough technology can provide life science companies with a competitive edge in a wide range of molecular testing applications and industry sectors.

See more about the Seegene QuantPlex RV-16 Assay at booth 523 AACC in Los Angeles July 17 - 19, 2012.

Friday, June 15, 2012

Immunetics Receives FDA Clearance for BacTx Rapid Test for Bacterial Contamination of Platelets


Immunetics, Inc., has received U.S. Food and Drug Administration (FDA) clearance for its BacTx® rapid test for bacterial contamination in platelet units, as announced this week by Andrew E. Levin, Ph.D., Immunetics Chief Executive Officer and Scientific Director.

Immunetics’ BacTx rapid test addresses the greatest infectious risk in transfusion today. An estimated 1 in 2,000 platelet units is contaminated with bacteria — and medical studies are increasingly showing that such contamination is a significant cause of illness and death among transfusion recipients.

The FDA clearance allows use of the BacTx test on leukocyte-reduced whole blood-derived platelet units, a type of platelet preparation which exhibits relatively high rates of bacterial contamination due to the pooling of units from multiple donors. In the studies reported to the FDA, the BacTx test detected all of the bacterial strains tested, with sensitivity and specificity meeting or exceeding clinical requirements.

“Existing approaches to the detection of bacterial contamination have fallen short, leaving patients at risk. They rely mainly on the culturing of the platelet units, a decades-old method that takes up to several days to yield a result,” Dr. Levin noted.

“By contrast, the BacTx test can be run in about 45 minutes, making it suitable to test platelet units shortly before they are transfused into a patient,” he said.

With the FDA clearance, the BacTx test is now available for immediate evaluation and sale. Additional trials are underway to expand the range of applications for the test.

“Receiving FDA clearance for the BacTx test is a critical milestone for Immunetics,” Levin said, “culminating years of work in which we’ve taken a novel technology from concept through clinical trials and regulatory approval — and are now ready to address an urgent need in the blood bank and transfusion services market.”

Worldwide, more than 10 million platelet units are collected per year.

The results of clinical trials of the BacTx test were presented by Drs. Andrew Heaton (NSLIJ Health System, New York) and Michael Jacobs (University Hospital - Case Medical Center, Cleveland), the clinical investigators leading the trials, at the American Association of Blood Banks (AABB) meeting in October 2011.

Immunetics has issued patents on the BacTx technology, which was initially developed with support from the National Institutes of Health. The company has developed and markets other FDA-cleared products, including a test for Lyme disease, and is actively working on new tests for Babesiosis and Chagas disease — both of which are emerging risks to the blood supply.

Life Technologies and OpGen Sign Collaborative Agreement to Leverage Ion Torrent and Whole Genome Mapping Technologies


Life Technologies Corporation and OpGen, Inc., a commercial stage whole genome analysis company, announced that they have signed a collaboration agreement to develop systems, technologies and applications intended to improve the management and surveillance of microbial outbreaks in the public health and infectious disease markets.

"Life Technologies is the ideal partner to demonstrate the value of next-generation sequencing in the public health and hospital laboratory," said Douglas White, chief executive officer of OpGen. "OpGen's Whole Genome Mapping technologies in conjunction with the Ion Torrent system will provide a valuable new approach that will provide public health and clinical laboratories access to cutting-edge technologies for microbial analysis and outbreak management."

The rise in disease outbreaks due to food borne illnesses and hospital-acquired infections poses an ongoing threat. Public health officials and healthcare organizations need access to improved first responder technologies to rapidly identify disease causing agents in order to effectively control and contain outbreaks.

The Life Technologies-OpGen collaboration will focus on developing applications and analysis systems that enable the use of the companies' Whole Genome Mapping and Ion Torrent sequencing technologies for food outbreak and infectious disease analysis. OpGen's Whole Genome Mapping technology provides a rapid, comprehensive structural analysis of microbial genomes that, when combined with sequencing data, more accurately detects important novel genetic elements associated with toxicity, virulence and drug resistance. As part of the collaboration, Life Technologies will also join the public health consortium recently established by OpGen to evaluate Whole Genome Mapping and sequencing for confirmation and management of disease outbreaks.

"Just six months after we launched the PGM and released the first semiconductor sequencing chip, scientists in China and Germany used Ion's technology to decode the genome of the deadly German E. coli outbreak strain and rapidly identify its unique combination of toxins and virulence genes," said Gregg Fergus, President of Ion Torrent, part of Life Technologies. "We are excited to be collaborating with OpGen because of their focus on delivering improved infectious disease detection capabilities to PGM and Whole Genome Mapping enabled laboratories on a global basis. The PGM is the only sequencing platform with the speed, simplicity and scalability to allow public health officials to intervene in ongoing infectious disease outbreaks."

The above referenced products are for Research Use Only. Not intended for human diagnostics purposes.

NanoLogix Announces Development of Multi-Well, Rapid Diagnostic Test Variant and Exhibits at the ASM General Meeting


NanoLogix announced today its R&D team in collaboration with University of Texas Health Science Center - Houston (UTHSC-Houston) researchers, are developing a multi-well, microplate reader variant of the company's BioNanoFilter (BNF) diagnostics for use in large volume laboratory environments. Early analysis of the multi-well plates shows exceptionally fast live-threat results similar to the company's standard BNF technology. Starting this week, the NanoLogix BNF and BioNanoPore (BNP) technology will be on exhibit at booth #841 at the 112th General Meeting of the American Society for Microbiology in San Francisco, June 16 - June 19.

Research using NanoLogix technology from a recently completed clinical study will also be presented at the ASM General Meeting on June 17th. Dr. Jonathan Faro of UTHSC-Houston will present the research, which focused on detection, identification, and determination of antibiotic sensitivity of Group B Streptococcus (GBS) during pregnancy. Data showed NanoLogix diagnostics consistently provided results in a 4 to 6 hour window, dramatically shorter than standard culturing times of 48 to 72 hours. The data and the associated clinical study narrative is currently being formatted for submission for peer-review publication, as well as to the US FDA for acceptance as a non-invasive diagnostic technology.

"These are exciting times for NanoLogix," said CEO Bret Barnhizer. "Our technology has the potential to dramatically affect the course of human health and events over the past eight months have greatly enhanced our position for the future."

Rapid Live-Threat Tuberculosis Results

Recent R&D operations have also converged to dramatically enrich NanoLogix' bacteria and protozoa detection technology portfolio.

The detection for Tuberculosis (TB) utilizing NanoLogix' BNF and BioNanoPore (BNP) technologies has recently been completed by a major independent, third-party research laboratory. Live-threat TB was detected with NanoLogix BNP technology in 4 to 5 days, as opposed to 21 to 84 days with standard culture. TB was also detected and identified with the company's BNF technology in less than two hours. Peer-reviewed publication and FDA submittal are in process for results from both BNP and BNF Tuberculosis research.

"We are thrilled to be dramatically cutting bacterial detection times from days to hours for many pathogens," said Barnhizer. "Specifically, we have reduced wait times for TB from weeks to days, while protozoa detection times for Cryptosporidium, which is responsible for over 50 percent of waterborne illnesses, have been cut from weeks to hours. At the same time, we have been able to accomplish these results with improved quality of detection."

Strategic Diagnostics Inc. STEC Food Safety Product Receives USDA MLG Designation


Strategic Diagnostics Inc. (SDIX), a leading supplier of rapid detection solutions to the $1 billion food pathogen testing market, today announced that its RapidChek® CONFIRM™ non-O157 STEC Immunomagnetic Separation (IMS) test kit has been reviewed by the U.S. Department of Agriculture (USDA) and has been listed in the recently updated USDA Microbiological Laboratory Guidebook (MLG) 5B.02 as the IMS reagents to be used in E. coli testing.

On June 4, 2012, the USDA Food Safety Inspection Service ("FSIS") began monitoring of the "Big Six" non-O157 shiga toxin producing E. coli (STEC), incorporating the RapidChek® CONFIRM™ STEC test kit in their testing method. Recently, one of the Big Six, E. coli O145 has been implicated in an E. coli outbreak in the southern US, though the source has not been identified.

Tim Lawruk, Food Safety Marketing Director at SDIX, said, "Once again SDIX has been able to apply its expertise in antibody development to validate six highly specific antibodies to address the new USDA regulation for monitoring non-O157 STEC in beef products. The decision by the USDA to incorporate our IMS product into their testing method over competitive offerings further validates the performance of SDIX's antibodies. Working with the USDA FSIS, we were able to quickly develop and validate these reagents to meet the market's needs. We expect these reagents to be a valuable tool for the USDA, state and international regulatory agencies, and customers in the beef industry."

Continuing, Mr. Lawruk said, "The MLG is considered the "gold standard guide" to testing methods by many in the food safety industry. Our listing in the MLG should provide testing labs confidence that deploying SDIX's confirmation reagents will ensure that they are complying with the testing requirements of the USDA. Based on customer requests for additional STEC testing tools, we will also be incorporating these antibodies into a RapidChek non-O157 test kit to be launched shortly, which includes multiplexed lateral flow test strips for the verification of "Big Six" O-type. We expect these new IMS bead and test kit products to provide SDIX additional access to the estimated $57M E. coli testing market, which by some industry estimates, is expected to double over the next 3 years."

Tuesday, June 12, 2012

High Speed Bench-top Sequencing to Revolutionise Hospital Infection Control


A new generation of bench-top DNA sequencers can quickly and cheaply map the entire genetic codes of bacteria causing life-threatening infections. This technology has the potential to revolutionise the speed and accuracy with which potential outbreaks of MRSA, Clostridium difficile and other infections are detected and investigated.

This was shown by study published this month in BMJ Open, by researchers from Oxford, Leeds, Brighton and the Health Protection Agency.

For the study, samples were obtained from potential outbreaks of MRSA and Clostridium difficile causing problems in three UK hospitals. The samples were sequenced with a new bench-top sequencer. The study showed that obtaining the genetic codes of bacteria were useful in resolving otherwise puzzling clusters of infections and that the information could be made available within 5 days, fast enough for local infection-control teams to use it in planning the management of outbreaks.

Knowing the DNA sequences of bacteria causing healthcare-associated infections can help to identify the route and timing of person-to-person transmission. If this information can be made available quickly enough, hospital infection control teams may be able to step in and eliminate further spread. These sequencing technologies are rapidly becoming cheaper, faster, more accurate and simple enough to use that within a few years local hospitals are likely to be using them every day.

Professor Derrick Crook, infection control doctor at the Oxford University Hospitals NHS Trust and professor of microbiology at the University of Oxford said: “This is the first illustration of how rapid sequencing technology could play a huge role in managing hospital infections such as MRSA and C. difficile. Our findings provide several good examples of how rapid and precise sequencing could transform identification of outbreaks of healthcare-associated infection, and therefore improve hospital infection control and patient outcomes in routine clinical practice. In one example we monitored the genetic code of all new cases and compared them to the genetic code of previous cases thereby identifying new outbreaks.”

“As recently as two years ago it would have taken months and thousands of pounds to process such informative sequence information on hospital infections; now with high speed sequencing it can take as little as days and tens of pounds. Soon it may take only hours and just a few pounds. We can realistically begin to think ahead to a time when we can create a database of genetic codes for many kinds of germ, to continuously track the spread of infections within and between hospitals.”

Idaho Technology to Present at the 2012 American Society of Microbiology (ASM) General Meeting


Idaho Technology, Inc., a privately held clinical diagnostics company dedicated to providing the world's fastest, highest-quality instruments for pathogen identification and DNA analysis, today announced its participation in the 2012 American Society of Microbiology (ASM) General Meeting taking place June 16-19, in San Francisco, California. The Company and its collaborators will present several posters highlighting data from Idaho Technology's marketed FilmArray Respiratory Panel (FilmArray RP), as well as from its gastrointestinal disease and blood culture panels, which are currently in development. Idaho Technology will also have an exhibition booth (#514) where company representatives will showcase the FilmArray diagnostic platform.

Session II -- Monday, June 18, 2012

Title: Rapid Automated Multiplex PCR Diagnostics for Blood Pathogens; On-Site Testing in Clinical Microbiology Laboratories Authors: IM Ota, E Barker, A Hemmert, B Baarda, O Cham, B Barrett, K Kanack, E Amiott, B Lingenfelter, N Garrone, S Thatcher, R Crisp, A Blaschke, M Fisher, J Daly, H Salimnia, RH Widen, and K Ririe Poster: #1239 Time: 10:45am -- 12:30pm

Title: Detection of Bacterial Targets by a Multiplexed Respiratory Panel: Bordetella pertussis, Chlamydophila pneumoniae, Mycoplasma pneumoniae Authors: K Kanack, K Bourzac, S Richards, R Lems, PG Klenk, K Bloch, W Oswald, and B Lingenfelter Poster: #1715 Time: 1:00pm -- 2:45pm

Title: Evaluation of the FilmArray Gastrointestinal Pathogen Detection System for Infectious Diarrhea Authors: M Vaughn, J Gardner, B Harrel, R Wallace, R Crisp, A Pavia, T Barney, G Alger, J Daly, M Rogatcheva Poster: #1716 Time: 1:00pm -- 2:45pm

Session III -- Tuesday, June 19, 2012

Title: Detection of Clostridium difficile Infection and Other Pathogens in Children with Diarrhea by FilmArray GI Pouch Authors: B Harrel, M Vaughn, J Gardner, C Li, R Wallace, R Crisp, A Pavia, T Barney, G Alger, J Daly, M Rogatcheva Poster: #2233 Time: 10:45am -- 12:30pm

Title: Symptoms Associated with Molecular Viral Detection in the Utah Better Identification of Germs-Longitudinal Viral Epidemiology (BIG-LoVE) Study Authors: CL Byington, K Ampofo, A Herbener, T Miller, C Stockmann, X Sheng, AT Pavia, and R Crisp Poster: #2260 Time: 10:45am -- 12:30pm

Brown University Researchers Develop Fast and Reliable Flu-Detection Test


This kit can be easily accommodated in a first-aid kit. The prototype device uses both microfluidics and magnetics techniques to separate the influenza RNA. It then amplifies and identifies probes that are attached to the RNA. The innovative technology may promote tracking of influenza in real-time. Study results have appeared in the Journal of Molecular Diagnostics.

Back in April 2009, the H1N1 or swine flu virus mutated from pigs and was being transmitted from human to human. According to the World Health Organization, this virus killed over 18,000 people across the globe and was termed as the first global pandemic in over 40 years. Devices to combat such outbreaks are expensive and not reliable.

To overcome these issues, biomedical engineers at Memorial Hospital in Rhode Island and Brown University have designed a biochip that is capable of detecting the presence of pathogen. The device pinpoints particular RNA sequences and then uses small magnets to isolate the sequence that contains the flu from the remaining RNA strand. The end result is a rapid and reliable flu-detection test that could be used just like an iPhone.

Anubhav Tripathi, associate professor at Brown University, informed that the new device is affordable and can be used for on-site detection of various diseases like TB, HIV, or influenza.

The assay labeled as SMART stands for “A Simple Method for Amplifying RNA Targets.” It features a series of tubes that have bulbs on each end. In the SMART detector, a DNA probe with base letters is used, wherein the letters correspond with the code in the targeted sequence. The probe fastens to a particular RNA strand that is being assayed. The sample is then submerged with probes in order to make sure that all RNA molecules are attached to the probes. The team then fixed the probes to magnetic beads, which transport the genetic sequence for the flu RNA sequence. A magnet is then used to pull the RNA-probe pairs that are accumulated in the bulb via a tube and then the probes are deposited at a bulb at the other end. This junction of magnetism and microfluidics isolates the RNA-probe pairs from the adjacent biological debris, enabling clinicians to separate the flu strains easily and quickly for analysis. After isolating the RNA, it can be studied by nucleic acid sequence-based amplification (NASBA) method.

For biohazard detection, the research team is exploring separate technologies.

The study was funded by the National Science Foundation and the U.S. National Institute of Health.

Saturday, June 9, 2012

BD Obtains CE Marking for the BD MAX™ MRSA Assay


BD Diagnostics, a segment of BD (Becton, Dickinson and Company), recently announced that it obtained CE Marking for the BD MAX™ MRSA Assay to rapidly and accurately identify methicillinresistant Staphylococcus aureus (MRSA) in patients. Rapid and accurate information enables infection control measures to be implemented faster which can positively impact patient management.

“When we launched BD MAX earlier this year, our goal was to provide a next-generation molecular testing system designed to accommodate a broad range of assays that laboratories want and need,” said Tom Polen, President, BD Diagnostics – Diagnostic Systems.

“As the first healthcare-associated infection assay developed by BD for use on the BD MAX System, this milestone represents further confirmation of the potential of this fully-automated system. This systemenables laboratories to offer a broad range of molecular tests that meet both their current andfuture clinical needs.”

BD MAX is the first and only fully automated, bench-top molecular system designed to perform a broad range of molecular testing. This offers laboratory professionals the flexibility and versatility to perform CE/in vitro diagnostic (IVD) assays and user defined protocols on the same platform.

The dual functionality of open system and CE/IVD capabilities on the BD MAX System enables laboratories to consolidate a broad range of molecular tests on a single workstation. This flexibility provides clinicians with the best information to make critical treatment and management decisions to improve patient care.

According to Polen, BD plans to build on the successful launch of the BD MAX MRSA Assay by developing additional assays for the BD MAX System for a broad range of disease categories. There are now more than 20 assays in the BD MAX System’s content-rich menu pipeline.

Portable, Rapid MRSA Test that Takes Less Than an Hour Ready for FDA Submission


A portable microfluidics device that can detect the presence of MRSA in fluid samples in less than an hour is ready to apply for FDA clearance.

F Cubed LLC hopes its device will help hospital physicians quickly diagnose pathogens, eventually including pseudomonas and bacterial meningitis, from a small fluid sample.

Its device, called Nesdep, contains disposable biochips that are loaded with DNA from a 10- to 100 microliter-sized sample of blood or wound product. Using carbon nanotubes and AC dielectrophoresis, the biochip traps and quantifies target DNA in the sample in a matter of minutes, said CEO Les Ivie.

The hardware of the device comprises two components: a mechanism that extracts and isolates DNA from the fluid sample, and a second mechanism that moves that DNA through the biochip and connects to an iPad or computer to deliver results.

Nesdep is already available for use in water and food safety testing, and Ivie said his team is meeting with the FDA this month to begin its application process. Initially the biochip will be able to detect only MRSA, but the company expects to release a multi-target biochip by mid-2013, Ivie said. It’s working with an emergency room physician at South Bend’s Memorial Hospital on trials of the device.

About 90,000 Americans are sickened by MRSA each year. Hospital-acquired infections have been a hotbed for innovation as an increasing number of cases have demonstrated resistance to traditional antibiotics. Rapid detection devices already on the market include BD Diagnostics’ BD GeneOhm StaphSR, which was cleared in 2008, and Cepheid’s Xpert MRSA.

Nesdep’s value proposition, according to the company, is that it’s portable enough to run on power from a vehicle’s cigarette lighter, works in as little as 30 minutes without the use of reagents, and costs 10 to 20 percent of what laboratory-based tests cost.

F3 licensed its technology from the University of Notre Dame and is located at Innovation Park in South Bend, Indiana.

Tuesday, June 5, 2012

Cepheid Receives CE Approval for New STD Assays on Their GeneXpert System


Cepheid, Sunnyvale, CA, received CE approval for a new infectious diseases assay on their GeneXpert system. The new assay enables rapid detection and differentiation of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). The GeneXpert works with disposable, single-use cartridges that hold the sample and reagent in a small processing chamber. Many assays are already available like the MRSA, enteroviruses and Group B Streptococcus cartridges.

The GeneXpert itself is a closed, self-contained and automated platform. It combines on-board sample preparation with real-time PCR amplification and detection functions for nucleic acid analysis. The system is designed to purify, concentrate, detect, and identify targeted nucleic acid sequences and comes in a one, two, four, or 16-module configuration.

John Bishop, Cepheid’s Chief Executive Officer is cited in the press release:

“We are bringing to market a true next-generation molecular diagnostic product for detection of CT/NG a test designed from the ground up to provide unprecedented accuracy, ease of use, and results availability. We expect these innovative products to deliver new levels of confidence to clinicians making same-day decisions in consulting with, and treating, their patients the critical first step in effectively managing these diseases.”

Sunday, June 3, 2012

Lucigen Awarded Grant to Develop Rapid Test for Influenza


Lucigen Corp. said it recently received a $2.8 million phase two Small Business Innovation Research Phase grant to fund research and development of a diagnostic test for influenza.

The National Institutes of Health awarded Lucigen the grant to develop a point-of-care diagnostic testing device for influenza A, B and respiratory syncytial virus, the company said.

Middleton-based Lucigen is developing a test product that can accurately diagnose common respiratory viruses with high confidence in less than 30 minutes directly at point of need.

"The key factor enabling this game-changing technology is the development of a novel enzyme that converts RNA to DNA and isothermally amplifies it in minutes. These attributes have allowed the design of a device that does not use any microfluidics, pumps or valves, therefore greatly simplifying construction and significantly reducing the cost of the test," Lucigen said.

The new technology would be ideal for low resource and battlefield settings, and has long-term potential as an over-the-counter device, the company said.

A Blood Test to Spot All Strains of Bird Flu in Just 2 Hours


A single blood test can now detect the deadly H5N1 bird flu infection in just two hours time. Scientists have for the first time developed the world's most rapid and comprehensive diagnostic kit that can detect all known strains of avian influenza or bird flu (H5N1) through a single blood sample.

In comparison, the WHO World Health Organisation's gold standard test can test for only three of the 10 distinct genetic types of H5N1 virus (clades 1, 2 and 3). To detect all existing strains of H5N1 with the WHO detection method would not be possible. The new made-in-Singapore H5N1 test kit is being called the H5N1 real-time Reverse Transcription Polymerase Chain Reaction (RT-PCR) assay.

The close collaboration between scientists from the Experimental Therapeutics Centre (ETC) under the Agency for Science and Technology Research (A*STAR) and clinicians from Tan Tock Seng Hospital (TTSH) enabled the successful development of the test. With this highly advanced kit, doctors can now rapidly detect all existing strains of the H5N1 viruses in a single test with almost 100% accuracy, within a few hours. Experts say this is a big boost to public healthcare system and a great stride forward in pandemic preparedness against this highly infectious disease worldwide. The bird flu virus, scientifically termed as the Avian Influenza virus, is usually lethal to the birds and normally does not transmit to humans.

However, highly lethal and contagious strains like H5N1 avian influenza A virus that can 'jump' from birds to human have been reported to cause serious infections and even death rates as high as 60% in infected patients. Although anti-viral treatment is available, the potential for H5N1 bird flu virus to spark a pandemic remains a serious threat to public health as most humans do not have immunity to the H5N1 virus. Therefore, to successfully curb the spread of the disease during an outbreak, accuracy and speed of detection on the type of H5N1 virus is of essence for effective infection control intervention and patient management.

Co-developed by Dr Masafumi Inoue, a Senior Research Scientist and Project Director of Technology Development from ETC and Dr Timothy Barkham, a senior consultant of Laboratory Medicine from TTSH, this newly launched H5N1 test kit has been clinically validated by several hospitals in Southeast Asia. "We are excited to be able to contribute to the fight against H5N1 virus with our expertise and know-how. Our technology has greatly simplified and accelerated the process of detection and identification of new H5N1 variants. Such information is especially critical when the virus mutates to become more dangerous, such as in drug resistance." said Dr Inoue. To enhance its usability, this new H5N1 test kit has been designed to be compatible with the previously launched "4-plex" Influenza diagnostic kit.

The latter is already adopted for use by several regional hospitals in Thailand. Using such multiplex assays enables simultaneous detection and differentiation of the different types of influenza infection in a single test, which will save hospital labs and clinicians significant time and cost. "While there have not been any reported H5N1 cases in Singapore, this mutating subtype of influenza virus type A continues to be a concern. The ability to detect and characterise influenza strains remains important in the management of the disease. With this latest H5N1 assay, we can easily combine it with our previous 4-plex Influenza kit to differentiate which strain of Influenza is present with one test, giving a definite diagnosis and faster turnaround for our patients and our colleagues in infection control and public health," said Dr Barkham.

Bird flu has been a big problem for India. It has been reported from various parts of the country including Maharashtra, Gujarat and north eastern states like Tripura. India has also reported many human casualties besides loss in millions due to lost poultry products. a sngle test that can detect all strains can be a real boon for India where genetical tests to identify the strain can take months during which time the deadly influenza virus can spread through backward villages, making containment operations a real problem.

Friday, June 1, 2012

Azbil BioVigilant Responds to Patent Infringement Allegation


Azbil BioVigilant, Inc.,, inventors of Instantaneous Microbial Detection™, announced today that the Company filed a request, on April 12, 2012, with the US Patent and Trademark Office seeking reexamination of a patent involving the use of a laser diode, and which is the subject of patent infringement litigation filed earlier this year by TSI, Inc. TSI failed in a prior litigation filed in Minnesota against Azbil BioVigilant on the same patent, voluntarily dismissing that action. Azbil BioVigilant maintains that TSI’s claim is invalid since multiple prior art references taught the claimed use of a laser diode. Azbil BioVigilant also maintains that they do not infringe the TSI patent.

“Like others, our product line is an outgrowth of our early experiences in bio-defense. Early on, however, we recognized an unmet need among pharmaceutical drug makers who were looking to advance the methods in use to monitor their drug making environments,” said Azbil BioVigilant CEO Aric Meares. “Since then, we have worked very closely with the recognized brand names in Pharma and leading FDA regulatory experts to understand and address their unique needs for rapid microbial detection. We remain confident in our ability to continue to build on our leadership position, the broad patent portfolio and trade secrets incorporated into our IMD-A systems, and are taking all necessary steps to defend against recent patent infringement allegations which we believe are without merit,” he added.

Representing Azbil BioVigilant in its patent litigation is Amster, Rothstein & Ebenstein LLP.

Accelr8 and Denver Health Notified by Department of Defense for Rapid Diagnostics Award


Accelr8 Technology Corporation and Denver Health received notice that the Defense Medical Research and Development Program (DMRDP) recommended $2 million funding of a proposed 35-month project submitted jointly by Denver Health and Accelr8. The DMRDP solicited proposals to "advance state-of-the-art solutions for world-class medical care."

The joint proposal became the sole recipient under the Military Infectious Diseases Applied Research Award (MID-ARA) program for rapid detection of serious antibiotic-resistant infections.

The project will apply Accelr8's BACcel(TM) same-shift rapid diagnostic system to wound infections and other serious infections secondary to trauma. The intended scope encompasses the full range from battlefield injuries at Level III field hospitals through post-rehabilitation care, and medical care for veterans and their dependents. The MID-ARA program's purpose is "... to accelerate the transition of medical technologies into deployed products; and to accelerate the translation of advances in knowledge into new standards of care in multiple military-relevant areas."

Co-Principal Investigators are Ivor S. Douglas, M.D., and Connie S. Price, M.D., from Denver Health. They are, respectively, the Chief of the Division of Pulmonary and Critical Care Medicine, and the Chief of the Division of Infectious Diseases Medicine. David Howson, Accelr8's president, is the co-investigator who will lead the company's development team. Collaborators include the Department of Veterans Affairs Eastern Colorado Healthcare System (Denver), the Washington Hospital Center (DC), and Creighton University School of Medicine (Omaha, NE).

"Denver Health is delighted to secure this important grant with our partner Accelr8 to advance the science of clinical microbiology and therapeutics for critically ill and injured military personnel and, by extension, civilians suffering from life-threatening infections," said Dr. Ivor Douglas.

David Howson, Accelr8's president, said "we are honored to see our unique diagnostic capability recognized through extensive peer review for its potential value in serving the courageous men and women of the military. Throughout history, infection has served as a 'third army' causing severe casualties. Modern field medicine now prevails over microbial contamination, but infections acquired later during the course of care continue to cause grievous damage. We are excited to have leadership by Denver Health and collaboration with a growing network of premier research institutions to make the case for our innovative technology in this most deserving patient community."