Tuesday, April 30, 2013

Charles River Signs Partnership Agreement with Bruker to Sell the Axcess™ System, a MALDI Biotyper Solution for EM

Charles River is pleased to announce a partnership with Bruker to provide rapid, accurate microbial identifications to the industrial microbiology market, including pharmaceutical, biopharmaceutical, personal care and other manufacturing industries.  Through this agreement, the Charles River Endotoxin and Microbial Detection division will sell the Axcess™ System, an offering that combines the Bruker MALDI Biotyper system with a custom data analysis software solution that allows instantaneous access to the Accugenix® microbial database for identifications.

By combining the precision and robustness of the Bruker MALDI Biotyper technology with the Accugenix® cGMP compliant microbial database and software, the Axcess™ System can maximize performance for environmental monitoring applications while simplifying customers’ validation commitment.  As the Accugenix® database is frequently updated to reflect the inclusion of novel organisms relevant to industrial manufacturing facilities, customers will always have access to the most current and validated database for identifications, saving time and costs associated with validating library releases. Included in the Axcess™ System offer, Charles River will provide sequence-based identifications for those isolates that fail to be identified by the MALDI Biotyper, minimizing the customer’s need for a secondary system. By generating accurate and consistent microbial identification through this offer, manufacturing sites will be better able to reliably track and trend their facility for routine gridding studies or possible excursions. 

Dr. Gary Kruppa, Vice President of Business Development at Bruker Daltonics, stated: “We are delighted to be working with the Endotoxin and Microbial Detection division of Charles River on distribution of the MALDI Biotyper into the industrial and pharmaceutical microbiology markets. From my experience, the technical and sales teams that Charles River brings to this effort are among the best and most respected in these industries. With Charles River products in virtually every pharmaceutical microbiology laboratory, we are looking forward to working with Charles River to expand our efforts to make the MALDI Biotyper the new standard in microbial identification for industrial microbiology.”

“By partnering with Bruker Daltonics, the recognized industry leader in MALDI-TOF mass spectrometry, we have reinforced our mutual commitment to meeting our customers’ microbial identification needs with innovative and comprehensive environmental monitoring solutions. Our entire team here at Charles River is excited to introduce the Axcess™ System to the market and to represent the MALDI Biotyper by providing the same professionalism, responsiveness and expertise Bruker is known for,” stated Foster Jordan, Corporate Senior Vice President, Charles River Endotoxin and Microbial Detection.

Luminex Receives FDA Clearance for MAGPIX® Instrument with xTAG® Gastrointestinal Pathogen Panel

Luminex Corporation today announced it has received U.S. FDA clearance of its MAGPIX instrument, with its xTAG Gastrointestinal Pathogen Panel (xTAG GPP). This is the first clinical assay to be cleared on MAGPIX. xTAG GPP is the first U.S. IVD cleared test that can simultaneously detect 11 common viral, bacterial, and parasitic causes of infectious gastroenteritis from a single patient sample.

"Receiving FDA clearance of MAGPIX opens the door for clinical laboratories of all sizes to use xTAG GPP on this innovative instrument," said Patrick J. Balthrop , president and chief executive officer of Luminex. "By bringing a compact, cost-effective, easy-to-deploy multiplexing solution to the clinical market, MAGPIX makes molecular testing more accessible to all laboratories."

Based on Luminex's xMAP® Technology, the easy-to-use MAGPIX instrument is a versatile multiplexing platform capable of performing qualitative and quantitative analysis of proteins and nucleic acids in a variety of sample matrices. MAGPIX is compact making it attractive to laboratories with limited bench space. This affordable system can perform up to 50 different tests in a single reaction volume, greatly reducing sample input, reagents, and labor while improving productivity.

Traditional GI testing technologies and methods can take several days to deliver a single result depending on the pathogen. xTAG GPP is capable of delivering multiple results within five hours. Simultaneous molecular testing on a single sample within a single shift provides significant benefits to laboratories in terms of workflow and resource utilization.

"Tests such as the xTAG GPP that can detect viruses, bacteria, and parasites from one sample at the same time can help clinicians more quickly identify and treat what's causing gastroenteritis," said Alberto Gutierrez , Ph.D., director of the Office of In Vitro Diagnostics and Radiology at the FDA's Center for Devices and Radiological Health in an FDA press release when xTAG GPP was first approved by the Agency. "The test could also allow clinicians and public health professionals to more quickly identify and investigate the source of potential gastroenteritis outbreaks."

Luminex will be featuring xTAG GPP and demonstrating the MAGPIX instrument at the Clinical Virology Symposium (CVS), April 28–May 1 in Daytona Beach, FL, Booth #237. For more information on MAGPIX or xTAG GPP, please visit our website at www.luminexcorp.com.

About Gastroenteritis

Infectious gastroenteritis is an inflammation of the stomach and intestines caused by certain viruses, bacteria, or parasites. Common symptoms include vomiting and diarrhea, which can be more severe in infants, the elderly, and people with suppressed immune systems. Gastroenteritis can be spread easily through person-to-person contact and contaminated food, water, and surfaces.

Diarrheal disease strikes more than two billion times globally each year, and is a leading cause of child morbidity and mortality worldwide(1). In the United States alone, 99 million cases of Gastrointestinal (GI) infection occur annually, leading to more than 250,000 hospitalizations(2) and 17,000 deaths(3)—inflicting a significant toll on the healthcare system. Diagnosis of some causes of infectious gastroenteritis has traditionally required multiple tests across the microbiology, virology, and molecular laboratories for which results may not be available for several days.

Bruker Expands Capabilities of MALDI Biotyper Platform for Microbiology

At the 23rd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), Bruker shows new capabilities of the MALDI Biotyper™ platform.

The MALDI Biotyper (MBT) is the market-leading system for microbial identification based on MALDI-TOF mass spectrometry. It is widely used in clinical microbiology, industrial microbiology, animal health and food safety and has become the broadly accepted laboratory standard for next generation microbial identification. While conventional biochemical testing takes time-consuming incubation after selection of the microbes from the culture plate, the MALDI Biotyper allows for an instantaneous identification of colonies from a plate. The MALDI Biotyper system covers a broad range of more than 4,600 microbial isolates from gram-negative bacteria, gram-positive bacteria, yeasts, multicellular fungi and mycobacteria. It is broadly applicable as a standard identification tool in various fields of microbiology. Microbial identification with the MALDI Biotyper is done using a proteomic fingerprint. This unique species-specific pattern is automatically compared with reference spectra in the MALDI Biotyper library. In addition, the MALDI Biotyper supports the Open Microbiology Concept which allows customers to generate their own database entries from regional isolates via a push-button storage in a customer-specific sub-library.

The new second edition of the MBT Mycobacteria Library adds another 140 isolates from 37 new species. The library is fully compatible with all standard cultivation media for mycobacteria, such as solid Löwenstein-Jensen medium or in liquid culture using the MGIT™ system from Becton Dickinson. With these added capabilities the MALDI Biotyper covers now more than 130 species of mycobacteria.

The new MALDI Biotyper Pilot™ accessory complements the satellite software to a complete, barcoded and paperless workflow. The MBT Pilot is used for light-guided manual target preparation using cross hairs to indicate the next position for preparation on the MALDI target. Barcoding of the MALDI target and the sample, along with multiple isolate support, ensure that the complete process is fully traceable.

The new MALDI Biotyper Galaxy™ performs a quality-controlled automated deposition of the MALDI matrix onto the target plate. After the preparation it scans the target positions and checks if each spot is optimally prepared for MALDI Biotyper measurements. The MBT Galaxy has a seamless integration into the MBT server coupled with on-board barcode reading and automated loading of the associated project work list. Both MBT Pilot and MBT Galaxy are scheduled to be commercially available in 2013.

The revolutionary MALDI-Biotyper-Spectrum-Beta-Lactamase™ workflow (MSBL™) enables users to perform patented functional beta-lactam antibiotic resistance testing for selected antibiotics on the MALDI Biotyper platform. The cleavage of beta-lactam antibiotics, like penicillins, 3rd generation cephalosporins or carbapenems by resistant bacteria leads to specific mass shifts of the cleaved products. Such mass shifts can be observed and monitored using the MALDI Biotyper, and automatically interpreted with the MSBL software module, which is also expected to be commercially availability later this year.

Dr. Wolfgang Pusch, Executive Vice President - Microbiology Business at Bruker Daltonics, explained: “At the 2013 ECCMID in Berlin, Bruker is again showcasing very significant developments to further improve and streamline the established MALDI Biotyper workflow. The MALDI Biotyper Pilot and MALDI Biotyper Galaxy automation accessories add further functionality for quality control and traceability and at the same time reduce the manual workload of the operators. The MSBL method is another major step ahead to apply the MALDI Biotyper platform also in the fields of hospital hygiene and epidemiology to get fast results concerning resistance of bacteria to selected antibiotics.”

Professor David Livermore, University of East Anglia, Norwich, UK, commented: “I am very excited about the potential to detect beta-lactamases - and maybe other resistances - as well as to identify microbes by MALDI-TOF mass spectrometry. Early information about resistance is very important to antibiotic stewardship.”

About the Bruker MALDI Biotyper

The dedicated MALDI Biotyper solution enables molecular identification, and taxonomical classification or dereplication of microorganisms like bacteria, yeasts and fungi. Classification and identification of microorganisms is achieved reliably and quickly using proteomic fingerprinting by high-throughput MALDI-TOF mass spectrometry. Applications include clinical routine microbial identification, environmental and pharmaceutical analysis, taxonomical research, food and consumer product safety and quality control, as well as marine microbiology. The robust MALDI Biotyper method requires minimal sample preparation and offers low consumables cost. The MALDI Biotyper is available in a research-use-only version, or in an IVD-CE version according to EU directive EC/98/79 in various European countries. In the United States of America the MALDI Biotyper is available for research use only, and not for use in diagnostic procedures.

Life Technologies Partners with Ridom and Releases SeqSphere+ Software to Speed and Simplify Bacterial Typing

Life Technologies Corporation announced today that it is partnering with Ridom GmbH (Munster, Germany) to make SeqSphere+ whole genome bacterial typing software available for Ion Torrent users. This software enables any lab to perform fast, affordable, and automated high-resolution bacterial typing on the Ion Personal Genome Machine® (PGM™) sequencer.

Up to now, typing methods have lacked discriminatory power, been difficult to standardize, or been labor intensive. SeqSphere+ automated software enables any microbiologist to use a genome-wide approach, typing hundreds to thousands of genes, resulting in higher discrimination and more accurate typing of bacteria.

"It is our aim to deliver a fully integrated turnkey solution for public health and clinical research microbiology," said Dr. Dag Harmsen, University Hospital Muenster, Germany, who is also co-managing director of Ridom and was central in sequencing the deadly E. coli O104:H4 that killed more than 40 people in Germany in 2011. "Together our solution provides an easy workflow with nearly no user intervention, delivering high-quality results using the Ion PGM System. We are excited and feel privileged to work together with the developer/vendor of the fastest evolving benchtop NGS platform, Ion Torrent."

The Ion PGM Sequencer is already in use for subtyping flu viruses by the Global Influenza Network, a collaborative effort between Life Technologies and scientists at a number of the world's leading government public health organizations, veterinary agencies and research institutes. The network focuses on increasing speed, cost effectiveness and accuracy of influenza monitoring and vaccine development. Members share tools, experience and data using the PathAmp™ FluA Reagents and the Ion PGM™ sequencer.

Bacterial typing using Ion Torrent technology is fast and affordable.  Bacterial typing can be performed in less than a day from library prep to data analysis. The complete solution includes:
  • Ion Xpress® Plus Fragment Library Kit for library construction,
  • Ion Chef® System for high throughput sequencing or Ion OneTouch® 2 System to automate template preparation,
  • Ion PGM® Sequencer and Ion Chips with the 400 base-pair kit for long, accurate reads in as little as three hours,
  • Torrent Suite Software & Ridom SeqSphere+ Software for easy data analysis & assembly.
SeqSphere+ features include:

DNA re-sequencing editor edits and analyzes de novo (.ace) or reference-mapped assemblies (.bam) of NGS data (e.g., MLST, MLST+). Auto-correction of homopolymer related InDel errors.

Analytical tools select data entries from a comparison table for epidemiologic, evolutionary or functional analysis. Cluster and visualize data entries by using minimum spanning or UPGMA/Neighbor Joining trees.

Database to store, search, retrieve, export and create reports from your epidemiologic and DNA sequence data stored in an integrated database. Search new sequence entries against stored data.

Bacteria typing is automatically performed with user defined quality parameters (e.g., coverage, stop codons, frame shift detection, etc.) using public or self-defined query libraries and task templates.

Products referenced above are For Research Use only, not for use in diagnostic procedures.

BD Diagnostics Advances Commitment to a Fully Integrated Microbiology Solution with New Agreement

BD Diagnostics, a segment of BD (Becton, Dickinson and Company), announced today an international distributor agreement with Bruker Daltonics Inc. to sell and provide front-line technical support for the co-labeled BD™ Bruker MALDI Biotyper™ System.

Microbial identification and antimicrobial susceptibility testing is the end-point of the majority of work a microbiology lab performs on a daily basis and is very time consuming. The BD™ Bruker MALDI Biotyper™ System combined with automated antimicrobial susceptibility testing on the BD Phoenix™ Microbiology System and the BD EpiCenter™ Microbiology Data Management System, will facilitate a fully integrated, optimized approach for laboratory workflow.

"BD believes mass spectrometry technologies are the future of microbial identification," said Jamie Condie , Vice President and General Manager, BD Diagnostics – Diagnostic Systems, Infectious Disease. "Combining Bruker's expertise in this area with our advanced lab automation experience, the BD™ Bruker MALDI Biotyper™ System will enhance our customers' clinical decision making and laboratory workflow."

Antimicrobial susceptibility testing is conducted via traditional automated systems such as the BD Phoenix System.  The combination of these two proven technologies, the BD Phoenix System and the Bruker MALDI Biotyper, and data management through the BD EpiCenter System, will provide laboratorians with a new approach to identification and susceptibility testing, which is expected to reduce the turnaround time for critical diagnostic results, while also improving laboratory efficiency and costs. Identification of pathogens will occur in minutes versus hours – directly impacting patient management. 

The Bruker MALDI Biotyper is currently not available in the United States for in vitro diagnostic use.

This announcement is an update to the joint collaboration, co-marketing, and co-selling agreement with Bruker Daltonics Inc. in 2010. 

About the BD Bruker MALDI Biotyper System

The dedicated MALDI Biotyper solution enables molecular identification, and taxonomical classification or dereplication of microorganisms like bacteria, yeasts and fungi.  Classification and identification of microorganisms is achieved reliably and quickly using proteomic fingerprinting by high-throughput MALDI-TOF mass spectrometry.  Applications include clinical routine microbial identification, environmental and pharmaceutical analysis, taxonomical research, food and consumer product safety and quality control, as well as marine microbiology.  The robust MALDI Biotyper method requires minimal sample preparation and offers low consumables cost.  The MALDI Biotyper is available in a research-use-only version, or in an IVD-CE version according to EU directive EC/98/79 in various European countries.  In the United States of America the MALDI Biotyper is available for research use only, and not for use in diagnostic procedures.

About BD

BD is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. The Company is dedicated to improving people's health throughout the world. BD is focused on improving drug delivery, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery and production of new drugs and vaccines. BD's capabilities are instrumental in combating many of the world's most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs nearly 30,000 associates in more than 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry and the general public.

BioFire Submits 510(k) Application to FDA for FilmArray® Blood Culture Identification Test

BioFire Diagnostics, Inc. today announced that it has submitted the FilmArray Blood Culture Identification (BCID) Panel to the U.S. Food and Drug Administration (FDA) for 510(k) clearance.

The submission comes after the successful completion of clinical trials for the FilmArray BCID Panel. The panel provides automatic results for the most common infectious causes of sepsis, a significant cause of mortality and morbidity in adults, children and infants. BioFire anticipates commercial release of the panel in summer 2013, pending FDA clearance.

Using an easy procedure requiring only 2-3 minutes of hands-on time, the BCID Panel simultaneously tests positive blood cultures for approximately 90 percent of the gram-positive bacteria, gram-negative bacteria and yeast microbes that cause bloodstream infections.

In addition, the BCID Panel tests for common antimicrobial resistance genes associated with MRSA (Methicillin-Resistant Staphylococcus aureus), VRE (Vancomycin-Resistant Enterococci) and the newly emerging CRE (Carbapenem-Resistant Enterobacteriaceae).

Timely diagnosis and administration of effective treatments can significantly reduce mortality rates, duration of hospital stays and overall costs due to sepsis. The rapid and accurate FilmArray BCID Panel is designed to help hospitals identify bloodstream infections more quickly than commonly used methods in practice today.

“Our submission of the BCID Panel to the FDA marks another significant milestone in our efforts to expand the menu of tests for our FilmArray platform,” said Kirk Ririe, CEO of BioFire Diagnostics. “We believe the availability of the BCID Panel, the FDA-cleared Respiratory Panel, and our future Gastrointestinal and Meningitis Panels will continue to increase the utility of the FilmArray in the hospital clinical laboratory.”

About BioFire Diagnostics, Inc.

BioFire Diagnostics, Inc., formerly Idaho Technology, Inc., is a privately held clinical diagnostics company based in Salt Lake City, Utah. The company manufactures and distributes the user friendly FilmArray System to hospital-based clinical laboratories across the U.S. and EU. BioFire currently offers the FDA-cleared and CE IVD marked FilmArray Respiratory Panel. The company continues to broaden its FilmArray test menu with the regulatory application for the Blood Culture ID Panel, and ongoing development of a Gastrointestinal Panel and a Meningitis Panel.

BioFire holds more than 85 patents related to polymerase chain reaction (PCR), and has used its extensive patent portfolio to successfully market nearly 200 products to the clinical, research and military markets. BioFire customers include the Department of Health and Human Services, the Department of Defense, state and local law enforcement, and researchers and medical technicians across a spectrum of fields and industries.

Marshfield Food Safety Adopts the Atlas System, an Innovative Fully Automated Molecular System for Food Pathogen Detection

Roka Bioscience announced today that Marshfield Food Safety, LLC (MFS) has integrated the Atlas® System into its food safety testing operations. MFS, an independent testing laboratory owned by Marshfield Clinic and headquartered in Marshfield, Wisconsin, has implemented the Atlas System at two of its eleven locations. With adoption of the Atlas System MFS has the capability of running the Atlas Listeria Detection Assay and the Atlas Salmonella Detection Assay, both of which have received AOAC Performance Tested™ certification. MFS plans to use the Atlas System for molecular pathogen detection of Salmonella and Listeria in food and environmental, food ingredient, and finished product samples.

Roy P. Radcliff, CEO of MFS, explained, “The Atlas System from Roka Bioscience is one of the most accurate and robust systems we have evaluated. We always look for new technologies that will allow us to streamline operations while maintaining the highest quality of testing to our clients. The Atlas System provides superior traceability, quality control, and data integration with our LIMS. The Atlas System also offers improvements in efficiency through automation which translates directly into cost savings.”

The Atlas System is an innovative fully automated molecular instrument for the detection of pathogens in food and environmental samples. This instrument utilizes a simple three-step procedure—Enrich, Transfer, Automate—and is capable of processing over 300 samples in 8 hours. The system’s continuous workflow and high throughput provides greater efficiency, flexibility, and dynamic scalability to meet the ever-increasing demands placed on food safety laboratories.

“MFS works closely with all its clients and strives to provide solutions—not just test results,” said Paul Thomas, CEO and President of Roka Bioscience. “The Atlas System meets that need. Its accuracy, speed, efficiency, and traceability make it a complete value-added solution. We are thrilled MFS has adopted the Atlas System and is realizing the incredible value it brings to food safety testing.”

Marshfield Food Safety, LLC 

Marshfield Food Safety, LLC provides a broad range of services to food production and distribution companies, test kit and media manufacturers, and certification agencies in areas of food, environmental monitoring, regulatory compliance, industrial process control, process validation, method and procedure validation. Laboratory capabilities include the analysis of samples from a wide variety of matrices including: raw materials, food and beverage products, environmental swabs, and water. 

Roka Bioscience

Roka Bioscience is a privately held company focused on developing and commercializing innovative solutions based on molecular technologies for the industrial markets. The company’s scientific platform is based on proven, proprietary technologies used widely in clinical diagnostic testing and now being introduced into food safety and other industrial markets. Roka’s current product line provides food safety professionals with a fully automated molecular pathogen detection solution that delivers rapid, accurate results and improved laboratory efficiencies.

Friday, April 26, 2013

PathoGenetix and FDA to Evaluate Bacterial Identification System for Use in FDA Public Health and Food Safety Efforts

Collaborative research will assess the effectiveness of Genome Sequence Scanning™ (GSS™) technology in identifying pathogens involved in foodborne illness outbreaks, and shortening decision and response time in public health investigations.

PathoGenetix, Inc. has signed a collaborative agreement with the U.S. Food and Drug Administration (FDA) to evaluate the company’s proprietary bacterial identification technology for use in FDA foodborne illness outbreak investigation and response. The Genome Sequence Scanning™ (GSS™) system provides pathogen serotyping and strain typing, directly from complex mixtures such as enriched food and clinical samples, in just five hours.

Identifying the specific pathogen causing a foodborne illness outbreak is a critical step in defining the extent of the outbreak, determining the food involved, finding the source of the contamination and defining the scope of a product recall. The ability of GSS™ to derive useful data directly from a complex mixture and to shorten the time for pathogen subtyping, may allow for quicker decisions affecting public health.

“We are very pleased to collaborate with FDA to demonstrate the value of GSS™ in FDA efforts to ensure safe food and improve public health,” said PathoGenetix CEO Ann Merrifield. “Reducing the time involved in foodborne outbreak investigations means quicker response time, and that means fewer illnesses and deaths from contaminated food.”

The bacterial strain information provided by GSS™ is comparable to pulsed field gel electrophoresis (PFGE), the current gold standard for pathogen typing in foodborne illness outbreak investigation and response.

The increased automation in preparation, measurement and analysis in the GSS™ system has the potential to reduce the need for advanced laboratory and analysis skills in hospital and public health labs monitoring foodborne outbreaks, and in food industry labs conducting ongoing food safety testing and source tracking.

Other microbial identification systems like PFGE, and even new approaches such as whole genome sequencing (WGS), require a cultured isolate as input. Selecting and culturing a bacterial isolate is a complex and time-consuming process that requires experienced microbiology skills, expensive supplies, and multiple days to complete. The cultural independence of GSS™ eliminates the selection bias inherent in other molecular epidemiology tools. It also makes GSS™ compatible with newer pathogen detection methods increasingly used in clinical and food industry laboratories.

The collaboration will evaluate the GSS™ instrument, reagents and database on a variety of food samples typically collected by FDA during routine food safety audits or foodborne disease outbreak investigations. As a part of the collaboration, FDA bacterial strains of public health interest such as Salmonella, E. coli and Listeria will be added to the GSS™ pathogen database.

“The FDA is pleased to have the opportunity to evaluate this technology and its ability to complement our existing pathogen identification systems,” said Dr. Donald Zink, Senior Science Advisor at FDA’s Center for Food Safety and Applied Nutrition.

Researchers Develop First Lab-on-Chip for Detection of Multiple Tropical Infectious Diseases

The Agency for Science, Technology and Research (A*STAR) and Veredus Laboratories, a leading supplier of innovative molecular diagnostic tools, announced the launch of VereTrop, the first biochip in the molecular diagnostics market that can identify 13 different major tropical diseases from a single blood sample.

With its high level of automation, this lab-on-chip diagnostic kit is poised to transform the quality and efficiency of testing tropical infectious diseases, including dengue fever, malaria, chikungunya and hand, foot and mouth disease, in the field. 

The lead virologist in this project, Associate Professor Lisa F.P. Ng from A*STAR's Singapore Immunology Network (SIgN) said, "Tropical diseases often reflect common symptoms like fever, and may not be accurately diagnosed early by doctors. This portable test kit is a rapid and reliable method to accurately test for multiple pathogenic targets from just one blood sample in a matter of hours." 

Together with Professor Laurent Renia, an expert in Malaria Immunobiology at SIgN, the team from SIgN has successfully validated the kit on patient samples in the external fields of Northern Thailand, at the Thai-Myanmar border. 

Professor François H Nosten, the clinical collaborator at the Oxford Clinical Unit in Mae Sot and Director of the Shoklo Malaria Research Unit said, "This technology opens new possibilities for the accurate and rapid diagnostic of important infectious diseases that remain the main causes of illness in the tropics. Its versatility and ease of use will change the approach to diagnostics at the periphery of health care system." 

Developed with infectious disease expertise from A*STAR's SIgN, this biochip, which operates on STMicroelectronics' Lab-on-Chip platform, was initiated between ETPL, the technology transfer arm of A*STAR and Veredus in 2009. Prior to this, Veredus had licensed diagnostic technology from A*STAR in the areas of influenza and malaria. 

"Veredus and A*STAR have worked on several collaborative projects dating back to 2004," said Dr. Rosemary Tan, CEO of Veredus Laboratories, a Singapore-based, majority owned subsidiary of STMicroelectronics. "This latest project on VereTrop Lab-on-Chip has combined the strengths and expertise of A*STAR, Veredus, and STMicroelectronics to create a powerful multiplexed molecular product that can rapidly detect and differentiate symptomatically similar tropical infectious diseases and enable timely proper treatment." 

"After this journey of more than three years, we are glad that such a compelling technologically-advanced product with global healthcare benefits is ready to be launched to the market. Veredus is a good example of how local companies can work with A*STAR for a consistent stream of technology to develop products that can enhance their offerings and level them up to be competitive and relevant globally," said Philip Lim, Chief Executive Officer of ETPL.

LamdaGen Corporation Issued United States Patent for Diagnostics on Plasmonic-Based Nanosensors

LamdaGen Corporation, a nano-technology platform company that provides plasmonic sensors and systems for diagnostics and life sciences, announced the United State Patent and Trademark Office (USTPO) issuance of patent "Enzymatic Assays for LSPR" for performing quantitative diagnostics via Localized Surface Plasmon Resonance (LSPR). 

The patent claims broadly cover plasmonic surfaces and nano-particles used for LSPR-oriented ELISA. The Company's proprietary LSPR metallic thin-films are easily grown onto practically any solid support, thereby allowing compatibility with a wide range of current IVD systems — including plate-based throughput platforms and rapid diagnostic systems for Point-of-Care.

"Our plasmonic ELISA provides for rapid quantitative detection with excellent reproducibility at sensitivity levels exceeding conventional ELISAs by as much as four orders of magnitude," commented Randy Storer, CEO and Co-Founder of LamdaGen Corporation. "The issuance of this patent illustrates LamdaGen's unique ability to harness modern plasmonics for advancing In-Vitro Diagnostics (IVD)."

This patent is the latest addition to LamdaGen's growing global IP portfolio for plasmonic-based nano-applications in diagnostics, contaminant-monitoring and life science research.

About LamdaGen Corporation LamdaGen is a nano-technology platform company providing plasmonic sensors and analytical systems for diagnostic and life science markets. The company's Localized Surface Plasmon Resonance (LSPR) sensors and systems enable real-time detection of biomolecular interactions, as well as enzymatic and chemical reactions. LamdaGen is a privately held company headquartered in Menlo Park, California and is the first to offer commercial LSPR products.

Hand-Held Device Cheaply, Quickly Diagnosis Malaria

A Case Western Reserve University student-led startup aimed at saving lives through faster, better and cheaper malaria diagnosis won the 2013 LaunchTown Entrepreneurship Business Idea Competition at the University of Akron and took ninth-place—out of 1,200 entries—at the Rice Business Plan Competition, in the last two week. The team's product, based on common items, is a hand-held device that detects a magnetic substance that malaria parasites release when digesting red blood cells.

There, the pitch by company CEO John R. Lewandowski, who opened with the line, "What if I told you I could save one million lives every year with just refrigerator magnets and a laser pointer?", got raves and a replay on Fortune Magazine/CNN online. 

The team's product, based on those common items, is a hand-held device that detects a magnetic substance that malaria parasites release when digesting red blood cells. The Rapid Assessment of Malaria device, called RAM for short, can provide a faster and more accurate diagnostic test than those used now, at a lower cost of about 20 cents per patient, the team members say. 

Lewandowski, the Founder of DDG, is earning his master's in engineering and management and has teamed with his brother Mark, a first-year student who plans to major in computer science and accounting, the company's CFO. They are the sons of John J. Lewandowski, the Arthur P. Armington Professor of Engineering II in the department of materials science and engineering. 

The third team member is Brian Grimberg, an assistant professor of international health at the School of Medicine, who is one of the device inventors, startup co-founder and president. Grimberg currently also leads an international and interdisciplinary team of experts investigating malaria treatment and prevention options in countries around the world. 

The team has worked with a long slate of researchers across campus to create, test and build prototypes of the device. 

"There are currently an estimated 1 million deaths resulting from malaria infections every year, and 95 percent of those are children under the age of 5," Grimberg said. "If we could accurately detect all the malaria infections in the world and then quickly deliver treatment, there would be almost no deaths from this parasite."

Wednesday, April 24, 2013

BIOTECON Diagnostics Food Proof ® Real-Time PCR Systems Receive MicroVal Certification

BIOTECON Diagnostics, one of the leading developers of rapid micro methods for the food industry worldwide, has successfully MicroVal validated several food proof ® real- time PCR systems. BIOTECON Diagnostics’ food proof ® Enterobacteriaceae plus E. sakazakii Detection Kits in combination with the food proof ® Salmonella Detection Kits as well as Reagent D and the food proof ® StarPrep One Kit have been certified by Lloyd’s Register Nederland B.V. (Rotterdam, Netherlands).

“15 external laboratories participated in the studies, including Nestlé, L+S AG, FrieslandCampina Domo and SGS Germany, says Alois Schneiderbauer, Chief Business Officer (CBO) of BIOTECON Diagnostics, “we thank our customers for the good cooperation”.

With the globally recognized MicroVal certificate BIOTECON Diagnostics has set the stage for the global distribution of these products, which have been developed primarily for the quality-conscious baby food segment.

“With the achievement of this milestone we accomplish the increasing quality demands in the baby food industry, documenting our aim to cooperate with food producers in order to make food safer“says Kornelia Berghof-Jäger, Chief Executive Officer (CEO) of BIOTECON Diagnostics.

To meet the desire for better and faster detection systems for Cronobacter spp. (formerly E. sakazakii ) and Salmonella , BIOTECON Diagnostics has developed and MicroVal validated the food proof ® Enterobacteriaceae plus E. sakazakii Detection Kit and food proof ® Salmonella Detection Kits in cooperation with Nestlé, the world’s biggest food producer.

Within 24 hours the food proof ® Enterobacteriaceae plus E. sakazakii Detection Kit simultaneously detects all members of the genus Cronobacter spp. (formerly known as Enterobacter sakazakii ) which are highly pathogenic especially for babies, as well as the indicator organisms of the family Enterobacteriaceae . Thus, the method follows Regulation EC No. 2073/2005 of the European Commission which has been in force since January 2006. Both Enterobacteriaceae and Cronobacter spp. frequently occur in milk powder used for the preparation of infant formulae and follow up formulae.

The combination of this kit with the food proof ® Salmonella Detection Kit provides the following advantage for the user: All food samples tested negative for Enterobacteriaceae are also negative for Salmonella because Salmonella taxonomically belongs to the family of Enterobacteriaceae. Using the food proof ® Enterobacteriaceae plus E. sakazakii Detection Kit as a pre-screening for Salmonella drastically reduces the number of tests for this organism. This advantage has been recognized by leading baby food producers like Nestlé, who have successfully implemented both systems in their laboratories.

MicroVal is the European certification organization for the validation and approval of alternative methods for the microbiological analysis of food and beverages. The validation is carried out according to ISO 16140 “Standard Operation Procedure for the Validation of Alternative Methods“.

New Technique Developed at MU May Make Food Contamination Testing More Rapid, Accurate

Sales of chicken products in China plummeted recently during an outbreak of a deadly new strain of bird flu. From bird flu to mad cow disease, numerous food scares have made global headlines in recent years. A technique developed by University of Missouri Professor of Engineering Shubhra Gangopadhyay's group may make food contamination testing more rapid and accurate. The detection test also could accelerate warnings after bioterrorism attacks.

"Quickly stopping the spread of toxins saves lives, whether those toxins are from natural processes or enemy attacks," said lead author Sangho Bok, postdoctoral fellow working under the supervision of Shubhra Gangopadhyay in MU's College of Engineering. "Our technique uses nanoparticles to make detection one hundred times more sensitive than the standard method now used, known as ELISA. We have also reduced the time needed to detect a threat to only one hour, compared to four to six hours for ELISA."

Currently, Bok's testing method detects a toxin that causes food poisoning, a chemical known as Clostriudium botulinum neurotoxin A. Engineers and biologists at MU now seek to adapt the test to detect many other dangerous chemicals.

Beyond helping protect people from deadly toxins, Bok's technique may bring jobs and foreign investment to America. Study co-author and MU research professor, Keshab Gangopadhyay, hopes to open a factory in Missouri that will manufacture the nanoparticles used in the detection technique. To achieve this goal, Gangopadhyay founded Nanos Technologies LLC.

"Science, employment and economic development are all tied together," said Gangopadhyay. "Food safety testing presents a large market that is growing quickly in developing nations like China and India. MU engineering research helps Missouri tap into that market while creating local jobs and attracting the attention of investors."

The study "Femtogram-level detection of Clostridium botulinum neurotoxin immunoassay using nanoporous substrate and ultra-bright fluorescent suprananoparticles," was published in Biosensors and Bioelectronics.

Source: University of Missouri-Columbia.

Thursday, April 18, 2013

Thermo Fisher Scientific to Acquire Life Technologies Corporation

Thermo Fisher Scientific, the world leader in serving science, and Life Technologies Corporation, a leading life sciences company, have signed a definitive agreement under which Thermo Fisher will acquire Life Technologies for $76.00 in cash per fully diluted common share, or approximately $13.6 billion, plus the assumption of net debt at close ($2.2 billion as of year end 2012).

The transaction, which was approved by both companies’ boards of directors, will create an unrivaled leader in serving research, specialty diagnostics and applied markets. The combination builds on both companies’ technological strengths to accelerate results for life sciences customers working in proteomics, genomics and cell biology.

“We are extremely excited about this transaction because it creates the ultimate partner for our customers and significant value for our shareholders,” said Marc N. Casper, president and chief executive officer of Thermo Fisher Scientific. “The acquisition of Life Technologies enhances all three elements of our growth strategy: technological innovation, a unique customer value proposition and expansion in emerging markets.

“Our customers in research and applied markets will now be able to achieve even higher levels of innovation and productivity by working with the combined company. We’re especially excited about the new opportunities we will have to leverage our complementary offerings, fueled by a shared commitment to continuous innovation. For our shareholders, we expect the transaction to generate attractive financial returns, as well as significant and immediate accretion to our adjusted EPS.”

Gregory T. Lucier, chairman and chief executive officer of Life Technologies, said, “This transaction brings together two companies intent on accelerating innovation for our customers and achieving greater success in a highly competitive global industry. Further, this combination delivers immediate and significant cash value to our stockholders and represents a successful conclusion to the board’s strategic review to enhance stockholder value and develop an even stronger future for Life Technologies. We look forward to joining forces with the outstanding team at Thermo Fisher, which shares our commitment to customers, employees and the communities we serve.”

Casper added, “We look forward to welcoming our new colleagues from Life Technologies to the Thermo Fisher team. Together, we will be in an even stronger position to fulfill our company’s mission, which is to enable our customers to make the world healthier, cleaner and safer.”

Life provides innovative products and services to customers conducting scientific research and genetic analysis, as well as those in applied markets, such as forensics and food safety testing. With 2012 revenues of $3.8 billion, its comprehensive offering includes a broad range of reagents, consumables, instruments and systems. Life’s leading technologies are protected by approximately 5,000 patents and licenses, and it builds on this position through a strong commitment to innovation. Life has an expansive commercial presence and global footprint as well, with more than 10,000 employees serving its customers around the world.

It is expected that Life Technologies’ president and chief operating officer, Mark P. Stevenson, will have a significant leadership role in the combined company. In addition, Thermo Fisher intends to elect a member of the Life Technologies board of directors to the Thermo Fisher board.

Benefits of the Transaction

The acquisition of Life Technologies will create enhanced scale and depth of capabilities for customers working in research, specialty diagnostics and applied markets.
  • Strengthens technology and innovation leadership through complementary offerings that broaden Thermo Fisher’s industry-leading portfolio. Life has an extensive offering of consumables for genomics, and molecular and cell biology. It is well-known for its next-generation sequencing capability, and also has a range of technologies for bioproduction and forensics applications. These strengths, combined with Thermo Fisher’s leading offerings in analytical technologies and specialty diagnostics, create new opportunities to support the convergence of life sciences tools and diagnostics.
  • Creates the ultimate customer partner, enhancing Thermo Fisher’s commercial strength and global reach. Life transacts more than half of its orders online through a highly regarded e-commerce platform. This leading capability, combined with Thermo Fisher’s extensive research and healthcare customer channels, creates a world-class commercial infrastructure. The combined company will also build on its strong foothold in Asia-Pacific, particularly in China, to meet increasing customer demand in life sciences and healthcare.
  • Creates compelling value for shareholders, with attractive financial returns and new growth opportunities. The acquisition of Life presents the opportunity for $275 million of adjusted operating income synergies in year three following the close, consisting of $250 million of cost synergies and $25 million of revenue synergies. In addition, Thermo Fisher expects the transaction to be significantly and immediately accretive to adjusted EPS.

Rapid Micro Biosystems Announces ISO 9001:2008 Certification

Rapid Micro Biosystems, the provider of rapid, automated, non-destructive detection and enumeration technologies in microbiology, today announced it has been awarded the International Organization for Standardization 9001:2008 certification for its Quality Management System.

Rapid Micro Biosystems received its ISO 9001:2008 certification from TÜV SÜD America Inc, a globally recognized testing, inspection and certification organization. The new certification verifies that the Rapid Micro Biosystems' quality system and processes across the company's operations and manufacturing meets the rigorous requirements and comprehensive reviews of ISO 9001:2008 certification.

"This certification demonstrates our commitment to delivering the highest quality products and services to our customers," said Don Keren, Director of Quality at Rapid Micro Biosystems.

"Our products are used for quality control of pharmaceutical products, so it's critical that our customers can be confident that they are partnering with a company committed to meeting or exceeding their needs, " said Rapid Micro Biosystems' CEO, Steve Delity. "Completion of our certification process validates that we are not only a provider of innovative technology but a company dedicated to quality throughout our operation."

bioMérieux Launches TEMPO® AC, a New Automated Test for the Rapid Enumeration of Total Flora in Food Products

bioMérieux, a world leader in the field of in vitro diagnostics, launches TEMPO® AC, a new automated test which enumerates total flora in food products and environmental samples in 24 hours. With its fully-automated reading, this new TEMPO® test will help agri-food laboratories to save time and release their product faster. TEMPO® AC has already obtained the AOAC RI (Research Institute) validation.

The new TEMPO® AC test allows the enumeration of total aerobic mesophilic flora in as little as 24 hours. With such a solution, laboratories can provide information more rapidly to their customers, accelerate corrective action plans for out of specification results and speed-up the time to market, where positive release is a requirement.

The automated TEMPO® system meets the needs of our customers in the food industry with a cost effective solution that is less time-consuming and labor-intensive than traditional methods,” says Jean-Marc Durano, Corporate Vice President, Industrial Microbiology Unit. ”This new TEMPO® test reflects bioMérieux’s commitment to always propose solutions to help improve food safety.”

The fully automated TEMPO ®system, based on traditional MPN (Most Probable Number), ensures optimal user convenience, reduced hands-on time and faster turnaround time for accurate and standardized results. TEMPO® AC (aerobic count) completes the system’s menu, covering most quality indicator testing needs: TEMPO® EC (Escherichia coli), TEMPO® TC (Total Coliforms), TEMPO® CC (Coliforms Count), TEMPO® STA (Staphylococcus), TEMPO® EB (Enterobacteriaceae), TEMPO® YM (Yeast & Mold) and TEMPO® LAB (Lactic Acid Bacteria).

TEMPO® AC is already AOAC RI validated for a wide variety of food matrices, petfood and environmental samples.

Thursday, April 11, 2013

New Molecular Assay Provides Simple, Efficient Way to Detect Clostridium difficile

BD Diagnostics, a segment of BD (Becton, Dickinson and Company), announces it has received FDA clearance to market the BD MAX™ Cdiff Assay in the United States. The assay is performed on the fully-automated BD MAX™ System and is designed to rapidly and accurately detect the toxin B gene (tcdB), which has been shown to be essential to cause disease, in patients suspected of Clostridium difficile infection (CDI).

Rapid, accurate identification of patients with CDI enables timely and appropriate therapy and infection control interventions to prevent the spread of this infection in healthcare institutions. Use of molecular testing has been proven to reduce the number of healthcare facility-associated cases of CDI.(1) The assay was CE-marked in March 2012 and has demonstrated excellent performance in Europe.(2)

“The BD MAX Cdiff assay is a simple, easy-to-use, fully-automated method for detection of these dangerous bacteria,” says Tom Polen, president of BD Diagnostics – Diagnostic Systems. “FDA clearance of the BD MAX Cdiff assay gives our customers the ability to balance productivity and cost as they perform laboratory testing for an expanding menu of infectious diseases.”

According to the Centers for Disease Control and Prevention (CDC), CDI is a growing threat in hospitals, nursing homes and other healthcare settings. Infection rates are at historically high levels, killing 14,000 Americans each year and adding more than $1 billion in excess costs to the healthcare system. The National Action Plan to Prevent Healthcare-Associated Infections is targeting a 30 percent reduction of CDI rates, which may be prevented through a combination of infection control interventions and appropriate use of antibiotics.(3)

The BD MAX™ Cdiff assay is the third FDA-cleared assay on the BD MAX™ System. Other available assays include BD MAX™ MRSA for the detection of methicillin-resistant Staphylococcus aureus and BD MAX™ GBS for the detection of Group B Streptococcus. Both assays were categorized by FDA as CLIA Moderate Complexity tests. This latest milestone represents further confirmation of BD’s commitment to rapidly expand its menu, offering laboratories a broad range of molecular tests that meet both their current and future clinical needs.

1. Catanzaro et al., 2012 Real-time polymerase chain reaction testing for Clostridium difficile reduces isolation time and improves patient management in a small community hospital. AJIC 40:663-666
2. Le Guern et al., 2012 Evaluation of a New Molecular Test, the BD Max Cdiff, for Detection of Toxigenic Clostridium difficile in Fecal Samples. J. Clin. Microbiol. 2012, 50:3089-3090
3. MMWR. March 9, 2012. Vital Signs: Preventing Clostridium difficile Infections

Wednesday, April 10, 2013

HHS Awards Contract to Create Test to Identify Resistant Influenza Viruses

A diagnostic test to identify antiviral resistance in influenza is to be developed under an $1.8 million contract awarded by the U.S. Department of Health and Human Services to Becton, Dickinson and Co.,  Franklin Lakes, N.J. The development work will be done over two years at BD Technologies, the technology development arm of BD, in Research Triangle Park, N.C.  
The test would combine detection of influenza virus with identification of antiviral drug resistance in clinical respiratory samples.  It will use a platform that combines the development of a test for identification of influenza antiviral resistance with a test cleared by the U.S. Food and Drug Administration for detection of influenza A and B, the most common human influenza viruses.

“Knowing that patients are infected with viruses that are resistant to antiviral drugs can help guide physicians to appropriate treatment and management for controlling the spread of influenza infections in health care facilities and communities,’’ said Robin Robinson, Ph.D., director of the Biomedical Advanced Research and Development Authority (BARDA) in the U.S. Department of Health and Human Services. “This type of test, which could be performed easily in local laboratories, holds the potential to guide treatment options, helping to provide the best care to patients.”

The contract for advanced development is supported by BARDA, within the Office of the Assistant Secretary for Preparedness and Response.  The contract supports the development of a critical test that is part of a national pandemic preparedness strategy, which includes accelerating the advanced development of new methods for identifying antiviral drug resistance.

BARDA develops and procures medical countermeasures that address the public health and medical consequences of pandemic influenza and other emerging infectious diseases. and chemical, biological, radiological, and nuclear(CBRN) accidents, incidents and attacks.

CML HealthCare Inc. to Install Fully Automated BD Kiestra™ Microbiology Platform

CML HealthCare Inc., a leading community-based provider of laboratory and medical imaging services in Ontario and British Columbia, and BD (Becton, Dickinson and Company), a leading global medical technology company, today announced an agreement for CML to install two BD Kiestra™ Total Laboratory Automation ("TLA") systems. This fully automated microbiology system will be installed at CML's central laboratory by the third quarter of 2013. The BD Kiestra™ TLA system is designed to significantly increase overall microbiology lab productivity, streamline workflow, and shorten the time to results.

"We are very excited to be the first laboratory services provider in North America to be installing the BD Kiestra™ TLA system.  With our central laboratory processing approximately three million microbiology tests annually, this installation will be the largest in the world for the BD Kiestra™ TLA system," said Thomas Wellner, President and CEO of CML. "The implementation of the BD Kiestra™ TLA system will allow CML to increase our capacity, reduce result turnaround times, and contribute to the growth of our core laboratory business.  It will provide us with a significant competitive advantage and support a key pillar of our growth strategy which is to establish innovative hospital and other partnerships."

BD Kiestra™ TLA system automates the manual processes associated with inoculating and incubating microbiology specimens, and uses digital imaging of the inoculated specimens to shorten the time to detect bacterial growth. The increased efficiency, and quality improvements associated with automation allow for faster delivery of more accurate results to provide optimal patient care. In addition, laboratory staff is able to devote more time to analytical and value-added tasks.

"BD is proud to be working with CML HealthCare Inc., one of Canada's largest and most forward-looking laboratory services providers," said Tom Polen, President, BD Diagnostics - Diagnostic Systems. "Rapid diagnosis and treatment of infections is critical; however, many of the traditional testing protocols take two or three days to generate an actionable result.  Using the BD Kiestra™ TLA system, integrated with other rapid diagnostic technologies, CML will be a pioneer in implementing technology that can often reduce those times significantly.  We expect this to enable clinicians to provide patients with the most effective treatment earlier – thus improving the standard of care and avoiding unnecessary healthcare costs."

The BD Kiestra™ TLA system currently has an installation base of instruments at public hospitals, universities, and privately owned laboratories in more than eleven countries worldwide since its introduction in 2006.

Tuesday, April 09, 2013

Azbil BioVigilant Announces Partnership with University of Tennessee Pharmacy College

Azbil BioVigilant, Inc., inventors of Instantaneous Microbial Detection(TM), announced that the University of Tennessee (UT) Pharmaceutical Sciences Department will utilize Azbil BioVigilant's IMD-A(R) 300-series of rapid microbial monitoring systems in their state-of-the-art aseptic filling facility.

The University of Tennessee is a leading institution in training individuals in health sciences fields, and for the past 50 years has offered training in aseptic processing. "Our new manufacturing facility, now under construction, will provide an advanced training ground featuring cutting-edge technology such as Azbil BioVigilant's IMD-A system capable of real-time, around-the-clock environmental monitoring," said Professor Laura Thoma, Director of UT's Plough Center for Sterile Drug Delivery. "This laser-based technique leverages naturally-occurring fluorescence to detect microbes, in contrast to the culturing method in widespread use developed over a century ago," she added.

Aric Meares, CEO of Azbil BioVigilant, stated partnerships such as these signify enabling steps for the industry. "The FDA continues to encourage the adoption of new technologies that improve the sterile manufacturing process and reduce the contamination risk to medications. The pharmaceutical industry has made limited advancements in this area due, in part, to the lack of published data. Our partnership with the University of Tennessee will help to fill that information void," he added.

The University aims to complete research on topics of wide interest to pharmaceutical drug makers such as the relevance and impact of paradigm-changing microbial detection sensitivity via intrinsic fluorescence, the impact of rapid access to information warning of a change of state within the drug-making environment, and the use of IMD-A systems as part of a larger parametric (or real-time) product release process.

Azbil BioVigilant's IMD-A 300 and IMD-A 350 systems can detect immediately the presence of microbes in the pharmaceutical manufacturing process, and in doing so, greatly accelerate the quality assurance processes for drug batch release.

Wednesday, April 03, 2013

T2 Biosystems Announces Issuance of Patent Covering T2Candida® Assay

T2 Biosystems, a company developing direct detection products enabling superior diagnostics, announced the U.S. Patent and Trademark Office has issued a patent number US8409807 (the ‘807 patent) covering T2Candida® the Company’s flagship diagnostic test. T2Candida identifies sepsis-causing Candida species directly from whole blood at ~1CFU/mL sensitivity in approximately three hours compared with current methods that rely on blood culture and require two to five days. The patent describes the T2Candida test format and methodology to detect and identify Candida species in a whole blood sample.

“The highly sensitive and rapid T2MR® technology enables us to identify Candida cells directly within a blood sample even at low copy numbers eliminating time-consuming and costly sample preparation” said John McDonough President and CEO T2 Biosystems. “This piece of intellectual property adds further protection for T2 Bio’s breakthrough direct detection technology that we believe will have a profound impact on the diagnostic landscape for any molecular immunoassay or hemostasis target.”

The ’807 patent “NMR systems and methods for rapid detection of analytes” is the first patent to issue from a large patent family that describes proprietary assays and the core of the T2Dx system. The claims broadly describe the T2Candida diagnostic test. T2 Bio owns or has rights to over 20 worldwide patents protecting several of the Company’s assets including its T2MR technology T2Dx® instrument and various applications of the technology.

About Sepsis & Candidemia

Sepsis is a potentially life-threatening illness caused by the body’s severe reaction to infection by bacteria fungi viruses or parasites. It is one of the top 10 leading causes of death in the United States and each hour of delayed treatment increases the mortality of these patients by 8%. Candida is a fungal pathogen known to cause sepsis and it is associated with approximately 100000 cases of candidemia in the U.S. annually making it the fourth-leading cause of hospital-acquired infections. Currently candidemia has a 40% mortality rate which can be reduced to 11% with early identification of the specific species. Current detection methods rely on blood culture a process that can take two to five days before identifying a Candida infection. The T2MR® platform is able to detect species-specific Candida directly from whole blood without the limits experienced with optical detection technology even at low copy numbers and provide results in approximately three hours.

Slow Government Response Likely Contributed To More Illnesses In 2011 Salmonella Outbreak In Ground Turkey

An examination of a Salmonella Heidelberg outbreak linked to ground turkey illustrates that health authorities must be more aggressive in their efforts to detect and respond to foodborne illnesses, according to a new report by The Pew Charitable Trusts, titled "Too Slow: An Analysis of the 2011 Salmonella Ground Turkey Outbreak and Recommendations for Improving Detection and Response." In all, the contaminated food sickened a reported 136 people in the United States, hospitalized 37 and killed one, according to government data.

The Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture's Food Safety and Inspection Services (FSIS), working with state health departments, took 22 weeks following the first reported illness on February 27 to identify the contaminated food source. On August 3, Cargill began a recall of approximately 36 million pounds of ground turkey products—one of the biggest poultry recalls ever.

The report identified three weaknesses in how the government detects and responds to outbreaks, which must be improved:

  • Federal and state health officials fail to prioritize outbreaks involving salmonella, which each year leads to one million illnesses, $11 billion in healthcare costs, and more hospitalizations and deaths than any other foodborne bacteria or virus.
  • The CDC's national database of DNA fingerprints of foodborne pathogens does not include identifying information about the bacteria that are cultured from retail meat samples, namely where the contaminated food was produced or even its brand name.
  • Government agencies often wait until they are nearly certain of the food source responsible for an outbreak before contacting the food company that produced it.

"Foodborne illnesses are preventable, so when we experience outbreaks we must learn from our mistakes," said Sandra Eskin, director of Pew's food safety campaign. "Pew's analysis shows that there are steps public health agencies at the state and federal level can take that may enable them to more quickly identify the likely source of the outbreak, initiate the recall and protect consumers."

In its report, Pew makes several recommendations to improve foodborne illness surveillance, detection and response.

  • Public health officials should make the detection of and response to salmonella outbreaks a priority by creating an enhanced surveillance system in which these outbreaks are identified more quickly and health authorities interview patients as soon as possible.
  • When public health officials upload the DNA fingerprints of bacteria on retail meat and poultry samples onto the national database, they should include the name of the company that produced the food, the plant where it was processed, and the date it was purchased; all of this information could enable quicker identification of the contaminated food.
  • FDA, FSIS, CDC and state authorities must engage with food companies in the early stages of an outbreak investigation to obtain information, such as production schedules and distribution patterns that may help them more rapidly identify the food source and thereby prevent more illnesses.