Unique US-Chinese Lab to Head Off H7N9 Outbreak and Future Threats

The Center for Infection and Immunity at Columbia University's Mailman School of Public Health (CII) and the National Institute for Viral Disease Control and Prevention (NIVDC) within the Chinese Center for Disease Control and Prevention will open a Joint Research Laboratory for Pathogen Discovery to conduct surveillance, identify new infectious microbes, establish novel platforms for diagnostics, and develop drugs and vaccines to treat diseases in humans and animals.

It is the first time an international team will operate a laboratory within the Chinese Center for Disease Control. The agreement, years in the making and formalized on May 9, will "enable CII and Chinese CDC investigators to work side-by-side developing solutions for pandemic threats to global health" says Dr. W. Ian Lipkin, MD, Director of CII. 

The unique arrangement had its origins 10 years ago when Dr. Lipkin was invited by the government of China to help address the challenge of SARS. Together with Chinese scientists and officials, he developed a research plan for SARS and infectious disease control, and even appeared on Chinese television to allay fears and correct misconceptions regarding treatments. 

"In 2013 the threat is not the SARS coronavirus—this time the imminent threats are the H7N9 influenza virus and the new coronavirus emerging in the Middle East," says Dr. Lipkin, who serves a Scientific Director of the laboratory along with Xiao-ping Dong, MD, and Administrative Director Zhao-jun Duan, PhD, of the NIVDC. 

"This historic agreement comes at a crucial time. International collaboration is needed in the face of infectious disease outbreaks with the potential to rapidly cross borders and spread around the world," says Dr. Dong. 

Expected to be operational by in the summer of 2013, the new laboratory will employ state-of-the-art techniques to keep up with the rapidly increasing pace of pathogen discovery, which has been spurred by a global proliferation of microbial infections and improvements in methods for detection. New molecular diagnostic platforms; investments in pathogen surveillance in wildlife, domestic animals and humans; and the advent of social media tools that mine the Internet for clues to outbreaks of infectious disease are proving invaluable in early recognition of threats to public health. 

The new lab will open its doors at a time when pathogen discovery is pushing the boundaries of what is thought of as infectious disease by lending insights into the mechanisms by which microbes can contribute to chronic illnesses like cancer, peptic ulcer disease, and mental illness. 

Through a five-year agreement between Columbia and NIVDC, the lab will be funded by NIVDC.

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Luminex and Millipore Extend Their Global Supply and Distribution Agreement

Luminex Corporation today announced it has extended their global supply and distribution agreement with EMD Millipore—the Life Science division of Merck KGaA, Darmstadt, Germany. This long-term agreement strengthens the partnership and facilitates development of life science and protein assays by EMD Millipore for Luminex's flexible platform.

"We are very pleased to extend our global supply and distribution agreement with EMD Millipore, a leader in life science and protein research," said Michael F. Pintek , senior vice president of operations at Luminex. "EMD Millipore's broad selection of protein biomarkers in diverse research areas such as cancer, cell signaling, cellular metabolism, and immunology reflects their leadership in the life science research market. Together we can accelerate the pace of research and advance healthcare for people around the world."

As part of the agreement, EMD Millipore will continue to offer the full range of Luminex's xMAP® systems, including MAGPIX®, Luminex® 100/200™, and FLEXMAP 3D®. Luminex Technology is widely supported and validated across both clinical and life science research markets, with cumulative shipments to date nearing 10,000 total instruments and over 16,000 publications across a broad spectrum of applications. 

"EMD Millipore is committed to continue bringing to researchers the largest selection of assays and analytes for Luminex's instrument portfolio," said John Sweeney , head of life sciences business at EMD Millipore. "This renewal of our partnership with Luminex ensures that EMD Millipore can provide customers with a complete solution for multiplexed protein detection—encompassing assay kits, instruments, software and services—that will support them over the years."

EMD Millipore, a leader in multiplex assay kit development, has continued to push into emerging areas of research and recently announced the availability of MILLIPLEX® map human stem cell pluripotency kits and MILLIPLEX® map kits for cellular metabolism. Compared with traditional biomarker detection techniques such as western blots, these new kits increase assay throughput and specificity. Additionally, EMD Millipore recently released the newest version of their best-in-class multiplex data analysis package, MILLIPLEX® Analyst 5.1 software—one of the most robust data analysis tools available today for Luminex® platform-based multiplexed immunoassays.

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Chembio Awarded $750,000 Cooperative Research Agreement

Chembio Diagnostics, Inc. (CEMI) a leader in point-of-care ("POC") diagnostic tests for infectious diseases, announced today that it has been awarded a cooperative research agreement with a U.S. government agency for up to $750,000 for an eight month development project. The project is to develop rapid POC diagnostic tests for five infectious diseases associated with febrile illness and to multiplex them into one assay. The project also contemplates that the test would be optimized for use with a mobile reader that incorporates cell phone technology to enable the results to be recorded, transmitted and monitored remotely via a cloud system, in real-time.

Javan Esfandiari, Chembio's Senior Vice President of Research & Development and the inventor of DPP(R), commented, "We are pleased to be awarded this research project to develop a complex multiplex assay as it builds on our strength in developing multiplex products using our proprietary DPP(R) technology. Our DPP(R) technology, combined with the mobile reader being used in the project, will enable real time data collection and monitoring capabilities. As these infectious diseases can all exhibit similar clinical symptoms, a rapid multiplex test that could distinguish them would be very useful, particularly in field conditions, so that correct diagnosis and treatment could be provided on a timely basis."

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Flow Cytometer Technique for Testing Drinking Water

Biotech specialist Partec releases analytical instruments which use a novel method to determine bacterial counts in drinking water. The method is rapid and reliable and has been recommended by the Swiss Federal Office of Public Health.

A novel technique for determining micro-organism counts is helping to ensure the safety of drinking water. Using specially developed analytical instruments from German biotech company Partec, it is now possible to rapidly determine the microbiological status of drinking water. The procedure can be carried out at water companies, in distribution networks and at end consumers. Mobile testing is also possible.

The technique, called “Determination of total cell count and the quantitative relationship between cells with low and high nucleic acid content in fresh water by means of flow cytometry", is quick, reliable and cost-effective. It enables bacterial contamination in drinking water to be characterised in less than 15 minutes and has been added to the Swiss Federal Office of Public Health’s Food Codex as a recommended technique. In addition to time-consuming conventional routine checks, water companies and cantonal and state analytical laboratories now have access to an innovative technique able to be used as an early warning parameter or for on-going monitoring. A pilot system for online microbial monitoring has already been implemented at a waterworks operated by the City of Zürich.

The driving force behind the new development is the Environmental Microbiology Department at the Swiss Federal Institute of Aquatic Science and Technology (Eawag), located in the town of Dübendorf. After several years of collaboration, researchers from Eawag and Partec have succeeded in using flow cytometry, a technique previously used predominantly for cellular analysis for medical applications, to determine drinking water quality. The technique involves marking individual bacterial cells with a fluorescent marker and using fluorescence detection to count and characterise them in a laser beam. A stand-out feature of the technique is its ability to count large numbers of bacteria in just a few seconds. The new method dispenses entirely with the need for time-consuming bacterial cultivation in Petri dishes. By analysing samples in an automated unit (e.g. the CyFlow flow cytometer from Partec), it is possible to process more than 50 separate water samples per hour.

Partec has also realised the technical adaptation of its analytical instruments to meet the needs of mobile and online drinking water quality checks. As part of an Eawag project sponsored by the Berne-based Commission for Technology and Innovation CTI, the technique has been validated by an alliance of 14 Swiss and German institutions, including water companies, public and private analytical laboratories and research institutes. The technique has recently been awarded the status of a standard operating procedure in Switzerland’s Food Codex.

The foundations for the flow cytometry technique used were laid at the University of Münster. This keystone technology, which is now used for cell analysis worldwide, was developed and patented by Professor Wolfgang Göhde in 1968 and first commercialised by Partec in 1969.

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New Genotyping System Identifies Pathogenic E. coli Outbreak Strains

Research presented at the American Society for Microbiology General Meeting shows that PathoGenetix Genome Sequence Scanning (GSS) technology could be used to reliably differentiate and strain type pathogenic E. coli strains of public health and food safety significance. GSS provided strain level information comparable to PFGE, the current standard for pathogen identification in epidemiological investigation and response.

PathoGenetix, Inc., a commercial-stage developer of an automated system for rapid bacterial strain typing, announced today that it has successfully identified and strain typed a collection of 250 pathogenic E. coli strains obtained from the Centers for Disease Control and Prevention (CDC) using the company’s Genome Sequence Scanning™ (GSS™) technology. The findings are detailed in a poster presented at the General Meeting of the American Society for Microbiology in Denver.

The 250 E. coli strains, which included the most frequently isolated STEC (Shiga toxin-producing E. coli) serotypes from both sporadic cases and multiple foodborne illness outbreaks, were run on the company’s prototype Genome Sequence Scanning system. The results showed that the system could be used to reliably differentiate and strain type STECs of public health and food safety significance, and aid in epidemiological investigation and response in foodborne illness outbreaks.

The GSS-generated phylogenetic tree clearly delineated the major STEC serotypes, and generally clustered the 250 strains into their appropriate serotype-specific branches. Strains that originated from the same foodborne illness outbreak also clustered together on the phylogenetic tree, demonstrating the system’s ability to differentiate outbreak clusters from each other and from epidemiologically unrelated strains. The strain information provided by GSS was comparable to pulsed field gel electrophoresis (PFGE), the current standard for pathogen typing in foodborne illness outbreak investigation and response.

Genome Sequence Scanning isolates and analyzes genomic DNA from either a complex mixture or a pure culture, provides strain type information and predicts the bacterial serotype in five hours, days faster than current identification methods. The GSS technology will be commercially available in 2014 in PathoGenetix’s RESOLUTION™ Microbial Genotyping System.

Of the numerous types of bacteria categorized as Escherichia coli, or E. coli, some cause disease by producing a toxin called Shiga toxin. Since 1993, when four children died and more than 700 people were infected with E. coli O157:H7 in ground beef, there has been an increasing focus on these “Shiga toxin-producing” E. coli (or STECs) in public health, food safety and regulatory efforts. The CDC lists E. coli STEC O157 in the top five pathogens contributing to domestically acquired foodborne illnesses resulting in hospitalization, estimating that it is responsible for 2,138 hospitalizations each year.

In the past 10 years, other E. coli STEC serotypes have been identified in major outbreaks, as dramatically illustrated in Germany in 2011 when more than 4,000 people became ill and 50 people died due to E. coli O104:H4. In 2012, six additional strains of Shiga toxin-producing E. coli (STECs O26, O45, O103, O111, O121 and O145) were declared adulterants by the U.S. Department of Agriculture Food Safety and Inspection Service (USDA-FSIS), which plans to expand testing for these “Big 6” non-O157 strains next year. Although beef remains the most common source, STECs have been linked to major recalls in numerous other foods including spinach, lettuce, cucumbers, peppers, sprouts and currently, frozen foods.

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Specific Technologies Bloodstream Infection Identification Solutions Discussed at the ASM Conference

At the American Society for Microbiology conference, award lecturer Dr. Christine Ginocchio discussed Specific Technologies blood culture system as an upcoming solution for rapid identification of microorganisms producing bloodstream infection. Dr. Ginocchio is the Senior Medical Director and Chief of the Division of Infectious Disease Diagnostics at North Shore-LIJ Health System, the nation's 2nd largest not-for-profit, non-sectarian health system.

At the BD Award for Research in Clinical Microbiology presentation "Rapid Detection and Identification of Blood Stream Pathogens" Dr. Ginocchio described the groundbreaking Specific Technologies solution that identifies microorganisms during culture. Current standard practice requires completion of a blood culture and then requires additional time consuming and expensive molecular or chemical analysis. The Specific Technologies solution has demonstrated detection of infection and identification of species in blood culture 4-fold faster than the industry standard technology leading to early intervention that can save lives, with less lab labor and no additional instruments. 

Bloodstream infection causing sepsis is the 10th leading cause of death, responsible for 11% of ICU admissions, with a mortality rate estimated at 28% to 50%, adding up to $50K costs per patient. To determine blood infection worldwide more than 150 million blood cultures are performed annually. Time is of the essence, survival rates decrease every hour without effective antibiotic treatment.  Current blood culture practice typically takes 2 to 3 days before results can guide the effective antibiotic choice.

Dr. Ginocchio remarked, "During growth in culture bacteria produce small molecule volatile metabolites unique to their species and strain. The Specific Technologies system for identifying the microorganism from its metabolomic signature is an exciting new technology that can save precious hours critical to effective treatment of bloodstream infection causing sepsis."

Ray Martino a founder and COO of Specific Technologies, commented, "Current blood culture systems can only indicate the presence or absence of bacteria, with no information regarding ID. Not only does the Specific Tech system provide ID during culture but analytical studies have shown ID is provided more than 20% faster than current systems simply detect a positive presence."

Mr. Martino continued "We appreciate the consideration of Dr. Ginocchio a widely recognized expert in microbiology and infectious disease attested to by her track record of research and clinical leadership and advisory positions to the FDA, NIH, and IDSA, her grants, and her invited talks."

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Antibiotic Stewardship Program Using Mass Spec System Reduces Hospital Stays, Costs

A co-author of a groundbreaking study documenting reductions in patient length of stay and overall costs from implementation of an antibiotic stewardship program using Bruker's MALDI Biotyper will share her observations at a Bruker symposium to be held during the upcoming American Society for Microbiology (ASM) General Meeting. The study, which is currently available in an online edition1, showed that the average length of stay was reduced by two days for participants in the antibiotic stewardship intervention group and overall costs were reduced by almost $20,000 per patient.

"We know that time is the enemy when dealing with serious infections," noted George Goedesky, Executive Director of Marketing/ Business Development. "This study demonstrates that reducing the time to diagnosis and optimal treatment through use of a rapid and accurate pathogen identification system, such as the MALDI Biotyper, when integrated into a comprehensive antibiotic stewardship program, improves patient care while significantly reducing length of stay and total costs."

The authors from The Methodist Hospital in Houston Texas set out to assess how patient care could be improved and cost savings achieved by a combination of rapid pathogen identification and a systematic approach to antimicrobial stewardship. Study patients with gram-negative blood infections were assigned to either routine care or to the intervention program, which included rapid pathogen identification and immediate antimicrobial susceptibility testing using the MALDI Biotyper, along with protocols for timely communication of results to inform therapeutic decisions.

The study authors report that in the pre-intervention period, final pathogen identification and susceptibility results took on average 47.1 hours, and in the intervention period, final results took 24.4 hours on average. The mean time to organism identification was 36.6 hours in the pre¬-intervention group versus 10.2 hours in the intervention arm. The mean length of stay in the pre-intervention group was 11.9 days with a mean hospital cost of $45,709. In the intervention group, length of stay averaged 9.3 days at an average cost of $26,162.

Patricia Cernoch, Manager of the Microbiology Laboratory at Methodist Hospital and a study co-author, commented, "At a time when pressures to reduce costs while improving patient care are escalating, we are delighted to show that combining a rapid and accurate pathogen detection system such as the MALDI Biotyper with common sense improvements in communication and treatment protocols produced such positive results for both patients and the hospital. We look forward to helping to implement similar programs throughout our system."

The MALDI Biotyper 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 laboratory standard for next generation microbial identification. The Biotyper system covers a broad range of more than 4,600 microbial isolates from gram-negative bacteria, gram-positive bacteria, yeasts, multi-cellular fungi and mycobacteria. Microbial identification with the MALDI Biotyper uses a proteomic fingerprint and allows for instantaneous identification of colonies from a plate. 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.

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Rapid Micro Biosystems Announces Hands-On Workshops at New European Headquarters in Munich, Germany

Rapid Micro Biosystems, a leading provider of automated, non-destructive, rapid microbial detection, today announced the opening of a state-of-the-art microbiology laboratory and headquarters located in Freising, just outside of Munich, Germany.

The new location provides office and applications development space as well as a dedicated laboratory environment for showcasing the new range of the Growth Direct™ System -- the company's automated, rapid, non-destructive microbial enumeration device -- in a lab environment. Located within 20 minutes of the Munich airport, the facility is easily accessed by public transportation.

Rapid Micro Biosystems will host one-day workshops showcasing the Growth Direct(TM) System and its applications for sterility, environmental monitoring, water and bioburden testing. The full day workshop will include a live, hands-on demonstration of the system and sample preparation techniques as well as presentation of testing and validation data. A schedule of upcoming workshops is available at www.rapidmicrobio.com\workshops.

"We are excited about the new facility because it provides an opportunity for companies that want to accelerate and automate their microbial testing to gain experience with the system and the range of applications. We see this as the best approach to demonstrate the unique value that the Growth Direct(TM) can bring to businesses," said Christof Hasse, Rapid Micro Biosystems' European Sales Manager.

For more information about the facility, or to register for an upcoming workshop, visit www.rapidmicrobio.com.

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mariPOC® Point-of-Care Immunoassay Outperforms Standard Culture in Group A Strep Infection Diagnostics

ArcDia International Ltd has released results from a clinical study comparing its rapid mariPOC® test product to the standard bacterial culture in detection of Group A streptococcal infections. The study results were presented at the GAS Infections 2013 conference, held in Rome in March, by Dr Jukka Vakkila from Mehiläinen. Mehiläinen is a leading private care provider in Finland.

The independent study included 121 patients who were tested for Group A streptococci with bacterial culture and mariPOC® rapid immunoassay. Bacterial culture was positive for 17 (14%) patients, whereas mariPOC® was positive for 31 patients (26%). The relevance of additional positive findings by mariPOC® was confirmed by clinical investigation of the patients. 90% of the additional positive findings were from patients with classical streptococcal tonsillitis symptoms and/or positive test result in a third diagnostic method.

"The results are in line with the previous data suggesting that mariPOC®  is a first rapid test to challenge the sensitivity of bacterial culture", concludes the presentation abstract by Dr Jukka Vakkila, who led the study at Mehiläinen, a leading private care provider in Finland.

"Standard culture was unable to diagnose a significant number of Group A streptococcal infections. In addition, mariPOC® produces results in 20 minutes whereas standard bacterial culture takes two days", comments Janne Koskinen, PhD, R&D Director at ArcDia International Ltd. "The new test enables physicians, for the first time, to trust in negative rapid test findings", he continues.

Earlier in 2013, ArcDia announced new additions to its management team and expansion of its distributor network in Europe.

About mariPOC®

mariPOC®   provides multianalyte diagnostic results for influenza like illnesses and tonsillitis in near patient settings in 20 minutes. The mariPOC® applications are targeted to acute respiratory infections, the most common infectious diseases on Earth. mariPOC® is superior in performance to the conventional test methods, including lateral flow rapid tests and standard bacterial culture. mariPOC® is designed to improve patient management and quality of health care, and it allows timely pathogen-specific diagnostics and medication.

About ArcDia

ArcDia International Ltd is the manufacturer of mariPOC®, world's first multianalyte point-of-care diagnostics test for respiratory tract infections. In the future, the company will develop additional point-of-care tests based on its proprietary ArcDia™ TPX detection technology. (Nature Biotech 2000:18). The technology is available for prominent industrial parties for in-licensing. Currently, ArcDia is actively seeking distribution partners for mariPOC®.

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New Bird Flu Detection Tests Fly from Queensland

The Queensland government has developed Australia’s first test to detect the new avian influenza H7N9 in humans in an effort to prepare for a potential pandemic of the recently discovered mutation of the virus.

Influenza is a virus that frequently mutates and its variations in the avian variety have proven no different since the initial spread of the H5N1 subtype across Asia in 2003, which quickly led to a pandemic across the Middle East and Europe in 2005. It is a virus that is contagious to humans through contact with infected birds, but it is more difficult to spread from human-to-human.

The previous form of Bird Flu has since mutated into another form, with the discovery of the H7N9 subtype in February and March 2013 in Eastern China when. Consequences of the H7N9 infection include pneumonia, respiratory failure, acute respiratory distress syndrome (ARDS) and even death according to reports to the Chinese Centre for Disease Control and Prevention that were cited in the New England Journal of Medicine (Mass.).

Persistent mutations have historically kept scientists around the world busy by constantly having to develop different vaccines just to keep pace with the continual changes in the virus sub types and strains.

The Queensland government has taken up the challenge of trying to prevent the potential spread to Australia of H7N9 even though the virus has so-far only been detected in Eastern China and Taiwan.

According to Queensland Health, scientists working for Pathology Queensland’s Microbiology Department and the Queensland Paediatric Infectious Disease Laboratory created the latest test for H7N9 to detect the latest strain of the avian flu.

The test involves taking a swab from the throats of people suspected of having influenza. The technical description of this procedure is a nasopharyngeal swab or nasopharyngeal aspirates.

These swabs are then sent to Pathology Queensland Central Laboratory at the Royal Brisbane and Women’s Hospital (RBWH) campus where the H7N9 strain can be immediately recognised at a genetic level by the scientists involved.

Queensland Minister for Health, Lawrence Springborg said his government believes there is no similar screening test incorporating the identification of the H7N9 strain in Australia.

“The fact this test has been developed right here in Queensland is a testament to the quality work of our microbiologists and lab technicians, and I applaud their initiative in helping to protect our communities,” Mr Springborg said.

Pathology Queensland director of microbiology, Professor Graeme Nimmo said the test was essential in helping Australia keep the virus at bay.

“It allows cases to be detected very rapidly, enabling treatment to commence in as short a possible time, limiting the spread of the disease and the impact on the community,” Professor Nimmo said.

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Nanosphere Announces Distribution and Collaboration Agreement With Hitachi High-Technologies Corporation

Nanosphere, Inc., a leader in the development and commercialization of advanced molecular diagnostics systems, announced today it has signed a distribution and collaboration agreement with Hitachi High-Technologies Corporation (Hitachi High-Tech). The agreement grants Hitachi High-Tech exclusive rights to market Nanosphere products in Japan. As well, the two companies intend to collaborate on assay and platform development.

The partnership plays a significant role in Nanosphere's global distribution strategy, as it expands the Company's product reach into one of the largest healthcare markets in the world.

"Nanosphere's portfolio of molecular diagnostics tests fits well with Japan's demand for rapid and accurate diagnostic tools to fight infections, enabling clinicians to target therapies potentially improving critical patient care and outcomes," said Kazuhiro Matsumura, Hitachi High-Tech's General Manager, Medical Systems Business Development Department, Strategic Planning Division, Science & Medical Systems Business Group. Mr. Matsumura added, "Nanosphere's rapid sample-to-result Verigene System meets the needs of Japan's health care providers who have been waiting for a molecular platform accessible to hospitals of all sizes."

"We are very pleased to be partnering with Hitachi High-Tech given their experience and reputation in both marketing and developing diagnostic products," said Michael McGarrity, Nanosphere's president and chief executive officer. "Hitachi High-Tech has a world class reputation for excellence and quality worldwide, and we jointly believe there is a considerable market and value creation opportunity that will be realized through this collaboration."

Benefits of Nanosphere's Growing Menu of Infectious Disease Products

The need for rapid, accurate and clinically actionable diagnostic results has been well defined in Europe and the USA with Nanosphere's broad menu of infectious disease tests:

• Gram-Positive Blood Culture test (BC-GP) to detect bacteria, including antibiotic resistance markers, that may cause bloodstream infections (510(k) cleared; CE Mark) 
• Gram-Negative Blood Culture test (BC-GN) to detect Bacteria including antibiotic resistance markers, that may cause bloodstream infections (CE Mark) 
• Respiratory Virus Plus test (RV+) to detect multiple respiratory viruses which cause respiratory tract infections (510(k) cleared; CE Mark) 
• Clostridium difficile test (CDF) to detect potentially deadly C. difficile and identifies the 027 hypervirulent strain (510(k) cleared; CE Mark) 
• Enteric Pathogens test (EP) to detect and multiple bacteria, viruses and toxin genes which cause gastrointestinal infections (In Clinical Trials). Nanosphere plans to commercialize the Enteric Pathogens test in 2013 following receipt of the necessary regulatory approvals. 

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New Test for H7N9 Bird Flu in China May Help Slow Outbreak, Prevent Pandemic

Breaking research appearing online today in Clinical Chemistry, the journal of AACC, demonstrates that a recently developed diagnostic test can detect the new strain of influenza (H7N9) currently causing an outbreak in China.

Since the end of March, 31 people have died from H7N9 infection, and the number of confirmed cases has climbed to 129. Evidence suggests that most H7N9 infections have arisen from poultry-to-human transmission, and that passage of the virus between humans is limited. However, researchers have also found mutations in the virus that are known to help avian viruses adapt to mammalian hosts. If these mutations lead to sustained human-to-human transmission, a serious pandemic could occur.

In this study, Wong et al. designed a diagnostic test with high specificity for the H7N9 virus that does not cross react with distantly related viruses, including all previously known avian and mammalian H7 viruses. They also show that this one-step quantitative real-time PCR assay enables specimen processing in about 3 hours.

According to the authors, this new test should also detect viruses closely related to the H7N9 virus. If confirmed, this capability could prove vital; it's likely that the H7N9 virus is evolving rapidly, and there could be multiple introductions of avian H7N9 viruses from animals to humans. The test also demonstrates a detection limit of ~0.04 median tissue culture infective dose (TCID50) per reaction. This means that it should be sensitive enough to identify patients with active virus replications.

"These results suggest that the established assay should be suitable for screening H7N9 viruses in human samples," said lead investigator Leo Poon, PhD, of the University of Hong Kong, though additional evaluation using clinical specimens from H7N9 patients is needed.

If validated, this diagnostic test could help health officials avert a potential pandemic by allowing them to monitor the spread of the virus. The test could also identify H7N9 patients in the early stages of infection, improving their chances of responding to clinical treatments.

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New Diagnostic Method Detects Five Pig Viruses in One Run

Researchers of CReSA and the Centro Nacional de Sanidad Agropecuria (CENSA) have developed a real-time PCR system for the detection and differentiation of porcine circovirus 2 (PCV-2), pseudorabies virus (PRV1), porcine parvovirus (PPV) and swine torque teno viruses 1 (TTSuV1) and 2 (TTSuV2).

In current intensive swine production, it is possible for pigs to be simultaneously infected with two or more viral pathogens. Hence, an aetiological diagnosis based on clinical signs is difficult, especially for respiratory and reproductive syndromes. Thus, the development of rapid and reliable methods for detection of these viruses is essential for epidemiological surveillance and disease management.

Real-time PCR techniques have improved the diagnosis of important viral livestock diseases and have become established scientific tools in veterinary virology and disease control. Particularly, the SYBR Green I-based real-time assay has proven to be one of the most effective tools in the rapid and differential detection of a variety of viral pathogens. The SYBR Green I assay is considered a flexible and cost-effective approach that, coupled with melting curve analysis, ensures reaction specificity along with multiplex detection of distinct targets.

The present study by CReSA and CENSA was undertaken to develop and evaluate a multiple SYBR Green I-based real-time PCR system for the detection and differentiation of PCV-2, PRV, PPV, TTSuV1 and TTSuV2 in a single run. The analytical and diagnostic performances obtained from the assessment of field samples, as well as the repeatability of the tests in the system; indicate the usefulness of this tool for laboratory diagnosis and epidemiological investigations.

This paper was published in Journal of Virological Methods by Pérez L.J., Perera C.L., Frías M.T., Núñez J.I., Ganges L., de Arce H.D. A multiple SYBR Green I-based real-time PCR system for the simultaneous detection of porcine circovirus type 2, porcine parvovirus, pseudorabies virus and Torque teno sus virus 1 and 2 in pigs. J Virol Methods. 2012 Jan;179(1):233-41.

Viruses studied

Porcine circovirus 2 (PCV-2) is recognised as the essential infectious agent of postweaning multisystemic wasting syndrome (SDPD), a multifactorial disease that causes significant financial losses in pig production worldwide. Several studies have shown that co-infections of pigs with PCV-2 and other viral pathogens, such as porcine parvovirus (PPV), pseudorabies virus (PRV) and swine torque teno sus viruses (TTSuVs), may enhance CVP2-associated lesions and increase the incidence of SDPD under both experimental and field conditions.

PCV-2 is a small non-enveloped virus with a single-stranded circular DNA genome of 1767-1768 nucleotides. The virus belongs to the genus Circovirus, family Circoviridae. This viral agent exhibits a high rate of evolution and can be divided into three viral genotypes. Moreover, PCV-2 is currently considered one of the most important emerging pig pathogens, and it is associated with a number of conditions collectively grouped as porcine circovirus diseases (PCVD).

PRV, also known as suid herpesvirus 1, is a member of the family Herpesviridae, subfamily Alphaherpesvirinae, genus Varicellovirus. The virus has a double-stranded linear DNA genome of approximately 150 kilobases (kb) in length. PRV is the causative agent of the pseudorabies (PR) or Aujeszky's disease, an infection that leads to severe economic losses in the swine industry worldwide.

PPV is an autonomous parvovirus classified into the genus Parvovirus, the subfamily Parvovirinae and the family Parvoviridae. PPV has a single-stranded DNA (minus-strand) genome that is approximately 5kb in size. This viral pathogen is a major causative agent in a reproductive failure syndrome in pregnant sows. More recently, PPV has attracted the attention of the veterinarian community because of the genetic variability found among field viral strains and the emergence of a new antigenic variant of PPV that displays a low cross-neutralisation activity against the vaccine viruses.

Swine torque teno viruses (TTVs) are small, non-enveloped circular single-stranded DNA viruses with genomes approximately 2.8 kb in length in the family Anelloviridae. At present, swine TTVs are classified tentatively into two species.

Whether swine TTVs play a significant role in the pathogenesis of specific pig diseases is still a matter of debate. However, both torque teno sus virus species 1 (TTSuV1) and 2 (TTSuV2) have been associated with the development of SDPD, and TTSuV1 has been linked to the induction of clinical porcine dermatitis and nephropathy syndrome (PDNS), suggesting that swine TTVs may serve as co-factors in intensifying diseases in pigs.

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Saskatchewan Disease Control Laboratory Selects Fluidigm BioMarkTM HD Platform to Track Infectious Agents

Rapid Detection of Pathogens by the Fluidigm System Will Help Control Serious Threats to Public Health such as Flu Pandemics and SARS.

The Saskatchewan Disease Control Laboratory (SDCL), operated by the province's Ministry of Health, has selected the Fluidigm BioMarkTM HD System as a cornerstone technology for its laboratory in Regina. The SDCL provides a variety of services to the public health institutions in the province, including testing for and monitoring of environmental specimens, food-borne illnesses, communicable diseases, influenza and a neonatal screening program.

The SDCL has developed a unique set of real-time PCR based tests which enables it to detect a wide range of respiratory and enteric diseases such as influenza, norovirus and salmonella. These tests will be used in conjunction with the BioMark HD System to rapidly identify pathogens. The BioMark HD System uses Fluidigm's distinctive microfluidic-based integrated fluidic circuits (IFCs) to quickly turn around up to 9,216 tests in parallel within hours of receiving the sample from the clinic.

"The emergence of super-bugs over the past few years has placed a spotlight on the critical role disease control labs such as the SDCL play in keeping all of us safe. New strains of influenza and emerging diseases require outstanding science, rapid response and a willingness to embrace the best technology the world has to offer. Fluidigm is excited to be working with the SDCL as it implements some of the world's most advanced science in the rapid detection of potentially dangerous diseases," said Gajus Worthington, Fluidigm President and Chief Executive Officer.

The BioMarkTM HD System

The BioMark HD System performs high-throughput real-time PCR using nanofluidic technology -- allowing scientists to collect more data points per day at less cost than conventional PCR systems. By miniaturizing the liquid handling steps required to carry out complex genetic analysis of biological samples, the BioMark HD System enables researchers to rapidly study differential expression of tissues with exceptional data quality, reliability and ease of use. The system has the ability to use a wide variety of sample types right down to the single-cell level, multiple chemistry options and additional capabilities such as genotyping, digital PCR and mutation detection.

About Fluidigm

Fluidigm develops, manufactures, and markets microfluidic systems to leading academic institutions, clinical laboratories, and pharmaceutical, biotechnology, and agricultural biotechnology companies in growth markets, such as single-cell genomics, applied genotyping, and sample preparation for targeted resequencing. Fluidigm’s proprietary microfluidic systems consist of instruments and consumables, including 13 different commercial IFCs for nucleic acid analysis, and three families of assay chemistries. These systems are designed to significantly simplify experimental workflow, increase throughput, and reduce costs, while providing the excellent data quality demanded by customers. Fluidigm products are provided: “For Research Use Only. Not for use in diagnostic procedures.”

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Neogen’s Soleris® Yeast and Mold Test Now AOAC Approved

Neogen Corporation has received approval from the AOAC Research Institute for its rapid and accurate test to directly detect yeast and mold in a variety of food matrices, such as dressings, sauces, pet food, dairy products, fruit and vegetable based products, as well as nutraceuticals.

Neogen’s newly approved Soleris® Direct Yeast and Mold (DYM) test produces accurate results in only 48 hours; conventional yeast and mold methods can take up to five days. This new test is designed for use in the Soleris rapid microbiology system, which accelerates and monitors microbial growth for faster time to results.

“The Soleris yeast and mold test was shown to produce rapid and accurate results—allowing for quicker product releases that improve profitability,” said Neogen’s Joe Heinzelmann. “Yeasts and molds are unique, as they represent a large and diverse group of microorganisms that can cause various degrees of deterioration and decomposition of foods. It is estimated that tests for yeasts and molds comprise as much as 15% of all microbiological tests performed worldwide. Soleris DYM enables food companies to ensure the quality and shelf-life of a wide variety of food products and provides advantages that allow companies to reduce costs through improved efficiency.”

The Soleris DYM test offers significant time savings of up to three days over the reference procedure while also reducing the amount of technician labor required. The AOAC approval allows Safe Quality Food (SQF) companies to comply with testing requirements for rapid yeast and mold assays.

A variety of representative commodities were tested in the validation including: nonfat dry milk, ice cream mix, salad dressing, yogurt, dried fruit, orange juice concentrate, tomato juice, corn flour, cocoa powder, dry pet food, and black pepper, and the test should perform well on similar food matrices.

The Soleris DYM test expands a portfolio of rapid indicator tests that are AOAC approved including:

• Total Viable Count results in 24 hours; conventional methods take 48 hours or longer.
• E. coli results in 7–10 hours; conventional methods take 24 hours or longer.
• Coliform results in 9–10 hours; conventional methods take 24 hours.

The Soleris test method for lactic bacteria produces results in 30–35 hours; conventional methods take 3–5 days.

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Corgenix Gains CE Mark for ReLASV® Antigen Rapid Test for Diagnosis of Lassa Fever

Corgenix Medical Corporation, a worldwide developer and marketer of diagnostic tests for cardiovascular disease, liver biomarkers and emerging pathogens and lethal viruses, today announced that notification of CE Mark was received for its ReLASV® Antigen Rapid Test for Lassa Fever diagnosis.

ReLASV is the first commercialized diagnostic test developed by Corgenix and other members of the Viral Hemorrhagic Fever Consortium (VHFC), a collaboration of academic and industry members headed by Tulane University partially funded with support from the National Institutes of Health (NIH). The new test kit enables rapid diagnosis of Lassa viral hemorrhagic fever, a highly infectious virus responsible for thousands of deaths each year across West Africa. The Lassa virus is considered a Category A (highest risk) pathogen and potential biowarfare agent by the National Institute of Allergy and Infectious Diseases (NIAID).

"This 15-minute test has the potential to completely change the way Lassa fever is detected and treated," said Douglass Simpson, Corgenix President and CEO. "Instead of having to wait days to find out if a patient has Lassa fever, health care workers are now able to diagnose and treat Lassa infections in the early acute stage, potentially saving many lives."

Lassa fever is a dangerous, often fatal disease common to much of West Africa with children and pregnant women being the highest risk groups; early stages of the disease are difficult to distinguish from other diseases. Lassa fever is spread by contact with infected rodents and is estimated to infect 300,000 to 500,000 people per year across the region, with at least 5,000 deaths reported annually. The illness is characterized by bleeding and coagulation abnormalities, with mortality rates reported exceeding 25 percent and reaching 50 percent during epidemics.

CE Mark notification was achieved following successful completion of a multi-year study of the clinical utility of the test to evaluate patients presenting with clinical symptoms of Lassa hemorrhagic fever. Corgenix will advance the ReLASV Antigen Rapid Test into full commercialization this year.

Under grants or contracts awarded in the past five years, the VHFC has developed and patented new recombinant proteins for Lassa virus and developed several viral detection products. The Consortium will continue its research activities in Sierra Leone, Nigeria, and other West African countries, advancing other laboratory tests for Lassa and other tropical viral diseases. The research will also assess the potential impact these new generation diagnostic products have on significantly reducing mortality rates through earlier treatment.

VHFC Lassa products have not yet been cleared for use in the United States by the U.S. Food and Drug Administration (FDA).

About Corgenix Medical Corporation

Corgenix is a leader in the development and manufacturing of specialized diagnostic kits for immunology disorders, vascular diseases and bone and joint disorders, including the world's only non-blood-based test for aspirin effect, and is active in the development of technology and products for emerging pathogens such as the viral hemorrhagic fevers. Corgenix diagnostic products are commercialized for use in clinical laboratories throughout the world. The company currently sells over 50 diagnostic products through a global distribution network and has significant experience in product submissions to the FDA and other worldwide regulatory authorities. Additionally Corgenix contract develops and manufactures products for key medical and life science companies in state-of-the-art facilities in Colorado. The company operates under a Quality Management System that is ISO 13485:2012 certified and compliant with FDA regulations. 

About the Viral Hemorrhagic Fever Consortium

The Viral Hemorrhagic Fever Consortium was established in 2010 as a result of several multi-year grants and contracts awarded to Tulane University by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to support Tulane's ongoing efforts to treat and prevent Lassa fever. The goal of the Consortium is to understand mechanisms related to the human immune response to Lassa virus infection. Specifically, by understanding what parts of the virus are recognized by the immune system, scientists can better understand mechanisms of antibody-mediated protection or pathogenesis in humans with Lassa fever. Consortium efforts have focused on the development of new recombinant proteins for Lassa virus diagnostic products, which have shown to be extremely effective in clinical settings in Africa. This progress is allowing a transition of efforts towards instituting better treatment of affected individuals and ultimately prevention of Lassa fever altogether. The Consortium is a collaboration between Tulane, The Scripps Research Institute, Broad Institute, Harvard University, University of California at San Diego, University of Texas Medical Branch, Autoimmune Technologies LLC, Corgenix Medical Corporation, Vybion, Inc, the Kenema Government Hospital (Sierra Leone), the Irrua Specialist Teaching Hospital (Nigeria) and various other partners in West Africa.

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PathoGenetix Advances RESOLUTION System for Rapid Bacterial Serotyping and Strain Typing

PathoGenetix, Inc. announced today that it has received the first of six “alpha” prototypes for its new rapid bacterial serotyping and strain typing system, and has begun internal testing of the instrument performance to specifications. Called the RESOLUTION™ Microbial Genotyping System, the fully automated system includes the instrument, bioinformatics software and database, and pathogen-specific assays, and will be commercially available in 2014 for use in food safety testing and foodborne illness outbreak investigations.

The RESOLUTION System is based on PathoGenetix’s proprietary Genome Sequence Scanning technology, initially developed to detect bio-threat pathogens in environmental samples under a five-year, $50-million contract through the Department of Homeland Security. The breakthrough genotyping technology isolates and analyzes DNA direct from complex mixtures—without the need for a pure culture isolate—and provides molecular serotype and strain type information for target bacteria in just five hours. The strain type information provided by GSS is comparable in resolution to pulsed field gel electrophoresis (PFGE), the current gold standard for pathogen identification.

“We are thrilled to reach this milestone in making Genome Sequence Scanning a reality for the food industry and public health agencies,” said PathoGenetix CEO Ann Merrifield. “The RESOLUTION System will dramatically reduce decision-making and response time in pathogen outbreak investigations and tracebacks, when every minute is critical and people’s health and well-being are at stake.”

PathoGenetix’s technology and development partner, Sagentia, will be completing the assembly and testing of the remaining “alpha” RESOLUTION instruments in their Cambridge, UK location, with anticipated completion in May. Over the next three months, PathoGenetix will test, validate and refine the instrument, which includes state-of-the-art optics, microfluidics and robotics. Sagentia will complete the development, coordinate the FCC, CE mark and UL compliance testing for the instrument and finalize the sourcing and manufacture of the instrument components.

The prototype instruments also will be used to verify the RESOLUTION System proprietary software, which detects and analyzes genomic fingerprints against an onboard database of strain fingerprints to determine molecular serotype and strain type. The RESOLUTION System Database will be created using the prototype instruments.

PathoGenetix will use the alpha systems to finalize instrument specifications, and expects “beta” prototype systems to be available in Q4 2013. The company has an agreement to place a beta instrument with one government collaboration partner, and is in discussion with other potential government and industry beta evaluation sites. Performance testing and submission to AOAC of the instrument, assays and protocols is planned for 2014.

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Quidel Completes Acquisition of BioHelix Corporation

Quidel Corporation, a provider of rapid diagnostic testing solutions, cell-based virology assays and molecular diagnostic systems, announced today that it completed the acquisition of BioHelix Corporation (BioHelix).

According to the terms of the deal, Quidel will pay BioHelix shareholders $10 million in cash, plus additional amounts in connection with an R&D earn-out based on the completion of a designated number of assays and a commercial earn-out dependent on product sales over a defined period.

Based in Beverly, Mass., BioHelix Corporation was established in 2004, and is among a number of successful enterprises spun-off from New England Biolabs, Inc. In October 2009, BioHelix entered into a collaborative R&D agreement with Quidel under which the companies would co-develop a number of hand-held, disposable molecular assays using BioHelix's proprietary isothermal Helicase Dependent Amplification (HDA) technology.

"The collaboration between BioHelix and Quidel has been effective and productive. Further, with the launch of AmpliVue C. difficile, we have demonstrated customer receptivity to a hand-held, disposable molecular platform, which gives us confidence that this additional investment in BioHelix and its isothermal amplification technology is warranted," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "HDA provides both speed and ease-of-use, without sacrificing sensitivity or specificity, and we believe this technology will not only benefit AmpliVue, but Project Wildcat as well."

With the acquisition of BioHelix Corporation, Quidel plans to accelerate the development of its AmpliVue isothermal assays and lower the associated manufacturing costs for those assays. Quidel currently sells the AmpliVue C. difficile Assay, which received FDA clearance in December of 2012.

Quidel plans to operate BioHelix as a wholly owned subsidiary of Quidel Corporation, and Dr. Huimin Kong, Ph.D., will remain as president of BioHelix.

"We welcome Dr. Kong, BioHelix, and its employees to the Quidel family, and are excited to add isothermal molecular assay development and enzyme manufacturing to our growing list of core competencies," added Bryant.

About Quidel Corporation

Quidel Corporation serves to enhance the health and well being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the QuickVue®, D3® Direct Detection and Thyretain® leading brand names, as well as under the new Sofia® and AmpliVue® brands, Quidel's products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza, respiratory syncytial virus, Strep A, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel's research and development engine is also developing a continuum of diagnostic solutions from advanced lateral-flow and direct fluorescent antibody to molecular diagnostic tests to further improve the quality of healthcare in physicians' offices and hospital and reference laboratories.

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