Thursday, June 26, 2014

Bruker MALDI Biotyper™ Receives Clearance as a Medical Device from the China Food and Drug Administration (CFDA)

Bruker Corporation announced that it has received clearance from the China Food and Drug Administration (CFDA) to market and sell its IVDMALDI BiotyperSystem as a medical device in China for the identification of microorganisms isolated from human specimens.

MALDI Biotyper-based microbial identification has major advantages compared to classical automated biochemical testing, including faster time to result (TTR) and better information with deeper and broader species coverage. Starting from a culture, the IVD MALDI Biotyper allows for microbial identification in a few minutes without further time-consuming incubation steps.

With this paradigm shift in clinical practice, microbial identification is typically available one day earlier than with biochemical techniques. Additionally, MALDI-TOF mass spectrometry-based identification does not have the limitations of biochemical testing and can analyze species that have been difficult to identify by previous microbiology techniques.

An increasing number of case reports describe the identification of microorganisms causing human infections which previously have been isolated only from environmental sources. The comprehensive IVD MALDI Biotyper reference library now covers more than 2,300 microbial species of gram-negative bacteria, gram-positive bacteria, anaerobes and yeasts, and often enables the identifications of unexpected microorganisms.

The IVD MALDI BiotyperSystem includes the bench-top microflex™ MALDI-TOF (matrix-assisted laser desorption ionization time-of-flight) mass spectrometer, automated analysis software, the IVD Bacterial Test Standard (BTS), a 96-spot MALDI target and an extensive library of microorganism reference entries. The microflex is the market-leading MALDI-TOF mass spectrometer for microbiology with a number of unique features specifically designed for applications in routine laboratories:

Commenting on the CFDA clearance, Dr. Lisong Shen, the Director of Laboratory Medicine at Xin Hua Hospital affiliated with Shanghai Jiao Tong University School of Medicine, and President of the Shanghai Society of Laboratory Medicine, said: “The importance of MALDI-TOF mass spectrometry technology in the clinical microbiology field is widely recognized in mainland China now. The approval of Bruker's IVD MALDI Biotyper system will further promote the development of clinical microbiology science in the country, not only in laboratory medicine, but also for infection control work within the hospitals. With the significant reduction of the time-to-result for identification of pathogenic bacteria, the patient outcomes will improve and the cost of care will be reduced significantly.”

Dr. Lu Xinxin, the Director of the Clinical Laboratory Department at the Capital Medical University-Affiliated Beijing Tongren Hospital, added: “MALDI-TOF MS is a revolutionary technology in microbiology. It is rapid, easy to operate and enjoyable to navigate in the microbial world."

Dr. Wolfgang Pusch, Executive Vice President of the Microbiology Business at Bruker Daltonics, commented: “The regulatory approval of the IVD MALDI Biotyper System in China is a major milestone and another achievement in our regulatory strategy to support the future growth of our business. We are committed to fully supporting our growing customer base in China. After the regulatory approval, we have immediately received positive feedback and have seen strong demand for the IVDMALDI Biotyper from the Chinese clinical microbiology market.”

Fast species ID is an important component to improve antibiotic stewardship by helping to guide selection of the right therapeutic drug(s). This is getting more and more important because of the increasing threat by multi-resistant bacteria causing severe infections. The IVD MALDI Biotyper System combines the most advanced MALDI-TOF mass spectrometer with the most extensive microbial species library in the market. Bruker continuously invests in bringing the MALDI Biotyper into clinical routine laboratories.

In 2009, the IVD MALDI Biotyper received the CE-mark according to the European IVD directive EC/98/79. Since then Bruker has continuously expanded the species coverage of the system and the geographic coverage of regulatory clearance, thereby adding clinical value for the existing customer base, as well as expanding access by new customers in additional countries. The IVD MALDI Biotyper is now available in most of Europe; in the Americas in Canada, Argentina, Colombia, Ecuador and Mexico; and in the Asia/Pacific region in Japan, China, Hong Kong, Singapore, Taiwan and Australia. Additionally, in November 2013 the MALDI Biotyper CA System received clearance for a first claim by the United States Food & Drug Administration.

About the Bruker MALDI Biotyper

The MALDI Biotyper family of systems 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. The MALDI Biotyper uses a molecular approach based on specific proteomic fingerprints from bacterial strains and published studies have highlighted better accuracy and lower cost, as well as typically much faster time-to-result (TTR).

Applications of the various MALDI Biotyper solutions include clinical routine microbial identification, veterinary applications, use by national, regional or local health and other regulatory agencies, environmental and pharmaceutical analysis, taxonomical research, food and consumer product safety and quality control, as well as marine microbiology. In many European and international laboratories the MALDI Biotyper has replaced classical biochemical testing for bacterial identification in recent years due to the accuracy, speed, extensive species coverage, ease of use and cost effectiveness of the system. Classical biochemical techniques depend upon detecting different metabolic properties of microorganisms, and can take hours or even days for analysis, and often lack specificity.

The robust MALDI Biotyper method requires minimal sample preparation and offers low consumables cost. The products of the MALDI Biotyper family are available in a research-use-only (RUO) version, or as the U.S. FDA-cleared MALDI Biotyper CA System, or in an IVD-CE version according to EU directive EC/98/79. The MALDI Biotyper also has medical device registrations in numerous other countries. Work-in-progress RUO versions of the MALDI Biotyper even allow selected high-value antimicrobial resistance tests in translational research.

Akers Biosciences Signs Distribution Agreement With Medline Industries

Akers Biosciences Inc., a designer and manufacturer of rapid diagnostic screening and testing products, announced a distribution agreement for the company's PIFA Heparin/PF4 and PIFA PLUSS PF4 rapid tests with Medline Industries Inc., the largest privately held distributor of healthcare supplies in the United States.

As per the terms of the Agreement, Medline is expected to begin marketing the Company's tests to a large network of hospitals and surgery centers across the United States immediately. Medline has a network of 40 distribution centers in the United States and 1,200 sales representatives worldwide.

The company believes that marketing within multiple hospital departments including but not limited to hospital pharmacies will help to increase market penetration of its PIFA Heparin/PF4 and PIFA PLUSS PF4 rapid tests.

PIFA Heparin/PF4 and PIFA PLUSS PF4 are the only FDA-cleared, single-use tests which quickly determine if a patient, being treated with the blood thinner Heparin, may be developing a drug allergy. The resulting clinical syndrome, referred to as Heparin-Induced Thrombocytopenia or "HIT", reverses the Heparin's intended effect of thinning the blood and transforms it into a clotting agent which can result in death or limb amputation.

Unlike traditional testing methods, which require expensive equipment, specialized laboratory personnel and a turnaround time of approximately 4-72 hours, ABI's PIFA Heparin/PF4 Rapid Assay delivers a result in less than 10 minutes after the blood sample has been prepared.

Maryland, French Companies to Develop Bacterial Detection Device

Two potentially life-saving technologies, developed 4,000 miles apart, will soon join together thanks to a partnership of the BioMaryland Center and the Medicen Paris Region. The Maryland Department of Business and Economic Development (DBED) announced the international project on Wednesday, from the BIO International Conference 2014 in San Diego.

The new collaborative effort is expected to result in the further development and commercialization of a bacterial detection device.

Opticul Diagnostics, based in Rockville, Maryland, is developing bacterial detection without the use of reagents to produce chemical reactions. Diafir, based in Rennes, France, produces a complementary product that eliminates the need for culture of the organism prior to detection. Its diagnostic solutions are based on infrared sensors to produce a more rapid, minimally invasive approach to detect infections, track metabolic diseases and identify tumors.

“We are excited as this funding will help Opticul move to the point of care space and facilitate our connection with Diafir,” Gallya Gannot, president and founder of Opticul, said in a statement.

“This funding is a great opportunity for Diafir to expand technologically and to penetrate to the medical point of care with a powerful bacterial identification device. Teaming with Opticul Diagnostics will result in a faster development and a superior technology,” Hugues Tariel, president and chief executive officer of Diafir, said in a statement.

Opticul is slated to receive up to $200,000 in matching funds from the BioMaryland Center, while Diafir is slated to receive up to 3 million euros in matching funds from Bpifrance, a funding partner of the Medicen Paris Region. The partnership between the two companies represents the first co-funded international project of the BioMaryland Center and the Medicen Paris Region, both government-sponsored economic development organizations focused on promoting the life sciences.

The two organizations first signed a Memorandum of Understanding during BIO International Conference 2012 in Boston. They represent compatible regions. While Maryland is the fourth largest biopharma concentration in the United States, the Medicen Paris Region represents one of Europe’s largest clusters of life science and health care companies.

“The partnerships we’ve made around the globe have been fruitful for Maryland’s economy and also signify the world-class nature of our innovators in fields like the life sciences,” said DBED Secretary Dominick Murray.

Secretary Murray joined Judy Britz, Ph.D., executive director of the BioMaryland Center; Jean-Roch Meunier, Délégué Général, Medicen Paris Region; Isabelle Lebo of the French public investment bank Bpifrance, and representatives of the companies during the project’s announcement.

Monday, June 23, 2014

Researchers Review Effectiveness of Rapid Tests in Diagnosing Visceral Leishmaniasis

Researchers from the Cochrane Infectious Disease Group, co-ordinated through the editorial base in LSTM, conducted an independent review into the effectiveness of rapid diagnostic tests in diagnosing patients with visceral leishmaniasis (VL), published in The Cochrane Library today.

VL (or kala-azar) is caused by a parasite and results in fever, a large spleen and other health problems. It occurs in India, Bangladesh and Nepal, east Africa, the Mediterranean region and Brazil. Without treatment it can be fatal, and proper treatment can result in cure, so diagnosis is extremely important. The diagnosis of (VL) relies on showing Leishmania parasites in tissue samples and on serological tests. Parasitological techniques are invasive, require sophisticated laboratories, consume time, or lack accuracy. Recently, rapid diagnostic tests (RDTs) that are easy to perform and safe have become available.

Researchers found 24 studies, which contained information about five different RDTs, with a total of 4271 participants. The report describes how accurate these rapid diagnostic tests are for diagnosing VL in people who, according to their physicians, could have the disease. Only studies in which the researchers had used established methods to distinguish the people with VL from those who did not have the disease were used in the review.

One RDT, the rK39 immunochromatographic test gave correct, positive results in 92% of the people with VL and it gave correct, negative results in 92% of the people who did not have the disease. The test worked better in India and Nepal than in east Africa. In India and Nepal, it gave correct, positive results in 97% of the people with the disease. In east Africa, it gave correct, positive results in only 85% of the people with the disease.

A second RDT, the latex agglutination test gave correct, positive results in 64% of the people with the disease and it gave correct, negative results in 93% of the people without the disease. For the other RDTs evaluated, there are too few studies to assess their accuracy.

Each index test was analysed separately and to ensure differences were accounted for correctly the following factors were explored: geographical area, commercial brand of index test, type of reference standard, disease prevalence, study size, and risk of bias.

Marleen Boelaert from Institute of Tropical Medicine, Antwerp, one of the authors of the review said: "The best chance of a cure for VL lies in a correct diagnosis, so utilising accurate RDTs is of paramount importance. Our review indicates that the rK39 ICT shows higher sensitivity and specificity for the diagnosis of VL in patients with febrile splenomegaly and no previous history of the disease than the latex agglutination test, but the sensitivity is notably lower in east Africa than in the Indian subcontinent. The size of the studies involving the other RDTs lack accuracy, validation, or both."

Cepheid And Leading Pharma Companies Partner On A Diagnostic Test To Tackle Multidrug-Resistant Bacterial Infections

Cepheid announced a new collaboration with AstraZeneca, Cubist Pharmaceuticals, Inc., and GSK intended to promote transformational change in infectious disease therapy by developing a rapid diagnostic test that can target multi-drug resistant pathogens and support the appropriate use of antibiotics.  Targeting bacterial infections with the right treatment will slow the development of resistance that has led to a crisis in treating infections.

Xpert® Carba-R is a rapid test under development for use with rectal swab samples to identify the presence of potentially life threatening bacteria.  Specifically, the consortium is working to extend the number of body sample types from rectal swabs to other body samples such as respiratory samples from patients with pneumonia.  Xpert Carba-R is commercially available outside the US, and is targeted for commercial release in the US in 2015, subject to regulatory approval.

According to a 2013 report by the US Centers for Disease Control and Prevention1 (CDC), up to 50% of all antimicrobial agents that are prescribed are unnecessary or are not likely to be effective as prescribed.  This has contributed to the emergence and spread of multiple species of bacteria that are resistant to many, and in some cases all, of the antimicrobial agents that are available for therapy.  In the United States alone, more than 2 million people each year acquire a serious bacterial infection that is resistant to one or more of the antimicrobial agents intended to treat it.

"There is clearly a need to identify patients with multidrug-resistant infections more rapidly and provide them with more potent antimicrobial agents, especially those that are active against multidrug resistant organisms," said Dr. Fred Tenover, Cepheid's Vice President for Scientific Affairs and former Director of CDC's Office of Antimicrobial Resistance.  "Once available, our Xpert Carba-R test could prove to be a valuable tool as the fight against multidrug resistant infections intensifies.  Cepheid is very pleased to be working with these distinguished pharmaceutical partners to meet their diagnostic needs, reduce the complexity of clinical trials, and accelerate the approval of these much needed anti-infective compounds."

Manos Perros, Vice-President and Head of AstraZeneca Infection Innovative Medicines added, "Developing rapid molecular diagnostics will enable physicians to treat patients suffering from bacterial infections with a new generation of safe and well tolerated antibiotics that will target drug-resistant pathogens in an effective way that is not possible with today's drugs.  The work of this consortium will generate diagnostics which we can use to match the right drug to the patient, help develop our emerging pipeline of pathogen-targeted antibacterials, and step up the fight against the threat of antibacterial resistance."

"Antibiotic resistance is a serious health crisis that demands immediate attention.  We need both to significantly improve our management of current antibiotics while also investing aggressively in new antibiotics to address these emerging threats," said Lorianne K. Masuoka, M.D., Senior Vice President, Clinical Development and Medical Affairs, and Chief Medical Officer of Cubist.  "A comprehensive and targeted approach combining rapid diagnostics with antibiotics will advance efforts to treat the right patients at the right time at the right dose and duration."

Concluding, Linda A. F. Miller, Ph.D., Director of Diagnostics and Clinical Microbiology for GSK Antibacterial R&D, stated, "Bacteria have responded to antibacterial drugs by developing resistance. To make sure we do not go back to the pre-antibiotic era where simple infections were very dangerous and many current hospital procedures and treatments would be impossible, we need to more effectively use the antimicrobials we have and we need to develop new medicines.  Accurate, rapid, easy to use diagnostic tests that can identify infecting pathogens directly from a patient sample will alter the way we treat bacterial infections by allowing us to enhance the efficiency of clinical trials and provide physicians with test results prior to making critical treatment decisions.  GSK enthusiastically supports the steps we are taking together with Cepheid, AZ and Cubist to help move us toward a new era in the development and use of antibacterial medicines."

Thursday, June 19, 2014

Rapid Diagnostic Nano-Devices Advance Health

A new $1.25 million research facility will support the development of cheap, ultra-precise and easy-to-use nano-devices for the rapid diagnosis and detection of health hazards.

The Ian Potter NanoBioSensing Facility at RMIT University will be established with the support of a $500,000 Ian Potter Foundation 50th Anniversary Commemorative Grant, announced today.
Research projects supported by the new facility include a nano-device that cuts diagnosis time of meningococcal from hours to minutes and an inexpensive nano-tool for diagnosing malaria in developing countries, that can give almost instant results and requires no medical training to use.

Associate Professor Vipul Bansal, Ian Potter NanoBioSensing Facility Director, said improving the accuracy, sensitivity and speed of diagnostic tools was crucial to effective health care.

"Speed is critical - the quicker we can diagnose, the quicker we can ensure a patient receives the right treatment," he said.

"The point-of-care nano-devices we're developing are not only inexpensive and simple to use, but also extremely sensitive, so they give an accurate diagnosis almost instantly.

"This new facility will enable the development of nano-devices for a wide range of diseases and health hazards.

"Importantly, it will also help us advance our research through the establishment of international collaborations that can maximise the global impact of these life-saving, leading-edge technologies."

The new facility will be supported by a $750,000 co-contribution from RMIT. Other research projects already in development include a prototype tool to test drinking water for the Cryptosporidium parasite, which cuts the detection time from five days to five minutes, super-sensitive nano-sensors for the food and dairy industries, and devices for early-stage diagnosis of cancer and cardio-vascular diseases.

Professor Calum Drummond, RMIT Deputy Vice-Chancellor Research and Innovation and Vice-President, said the new facility would enable the University to build on an emerging research strength.

"The Ian Potter Foundation's visionary support of this facility through its largest ever grant to RMIT will enable our researchers to develop smart technologies that have the potential to radically change health care diagnostics," he said.

"The Ian Potter NanoBioSensing Facility is set to become the nation's nanobiosensing hub, attracting top research collaborators from around the world.

"This project demonstrates the pivotal role of philanthropy in enabling outstanding and innovative research, and we are grateful for the Ian Potter Foundation's generous support."

The development of new nano-biosensing and diagnostic platforms using cross-disciplinary materials engineering approaches is one of RMIT's priority research areas for smart technologies.

Researchers at RMIT have been granted international and provisional patents for their novel nano-diagnostic platform, which is based on Surface Enhanced Raman Spectroscopy (SERS).
The user-friendly platform is inexpensive to produce and is readily applied to a broad range of biosensing challenges, enabling researchers to develop targeted nano-devices for personal, medical and industrial use.

The Ian Potter NanoBioSensing Facility will sit alongside the world-class infrastructure at RMIT's $30 million MicroNano Research Facility, which is due to open in August.

Researchers Create Better Methods to Detect E. coli

Kansas State University diagnosticians are helping the cattle industry save millions of dollars each year by developing earlier and accurate detection of E. coli.

Lance Noll, master's student in veterinary biomedical science, Greensburg; T.G. Nagaraja, university distinguished professor of diagnostic medicine and pathobiology; and Jianfa Bai, assistant professor in the Kansas State Veterinary Diagnostic Laboratory, are leading a project to improve techniques for detecting pathogenic Shiga toxin-producing E. coli O157:H7. A U.S. Department of Agriculture Coordinated Agriculture Project grant is funding the work.

The researchers are part of a College of Veterinary Medicine team studying preharvest food safety in beef cattle. Noll has developed and validated a molecular assay that can detect and quantify major genes specific for E. coli O157.

"Developing a method to detect E. coli before it can potentially contaminate the food supply benefits the beef industry by preventing costly recalls but also benefits the consumer by ensuring the safety of the beef supply," Noll said.

The newly developed test is a molecular assay, or polymerase chain reaction, that detects bacteria based on genetic sequences, which are the bacteria's "fingerprints," Nagaraja said. The test is rapid and less labor-intensive than existing detection methods. The method can be automated and test many samples in a short period of time.

The test can be used in a diagnostic or research laboratory to accurately detect E. coli and can help with quality control in cattle facilities.

"The novelty of this test is that it targets four genes," Nagaraja said. "We are constantly working on finding better and more sensitive ways to detect these pathogens of E. coli in cattle feces."

To develop the diagnostic test, Noll and Nagaraja worked with two Kansas State University molecular biologists: Xiaorong Shi, research assistant of diagnostic medicine and pathobiology, and Bai.

"Beef cattle production is a major industry in Kansas and Kansas State University has a rich tradition in the research of beef cattle production and beef safety," Noll said. "As a graduate student in veterinary biomedical sciences, I am proud to be a member of a multidisciplinary team in the College of Veterinary Medicine that aims to make beef a safe product for the consumers."

Noll was named a winner at the 11th annual Capitol Graduate Research Summit this spring for his research project and poster, "A four-plex real-time PCR assay for the detection and quantification of Escherichia coli O157 in cattle feces."

Alere Receives FDA Clearance for Influenza A and B Test

Alere Inc., a leading global provider of point-of-care rapid diagnostic and health information solutions, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for the Alere(TM) i Influenza A & B test, the first and only molecular test to detect and differentiate influenza A and B virus in less than 15 minutes.

"By providing the speed of a rapid test with molecular technology, Alere i delivers clinically meaningful and actionable results to clinicians -- enabling them to treat patients more quickly and appropriately," said Avi Pelossof, Alere Global President of Infectious Disease.

The clinical performance of Alere i Influenza A & B was established in a multi-center, prospective study conducted at eight U.S. trial sites during the 2012-2013 flu season, in which 585 prospective nasal swab specimens, collected from patients presenting with influenza-like symptoms, were evaluated with Alere i, and compared to viral culture. All specimens generating discrepant results between the Alere i Influenza A & B test and viral culture were tested using an FDA cleared RT-PCR assay to confirm influenza status.

Molecular testing involves the extraction and analysis of DNA or RNA strands to detect sequences associated with viral and bacterial causes of infections. Alere i Influenza A & B is the first molecular diagnostic test that delivers actionable, lab-accurate results in less than 15 minutes on a user-friendly platform. Unlike polymerase chain reaction (PCR) testing, Alere's proprietary Molecular. In Minutes(TM) (MIM) isothermal nucleic acid amplification technology (iNAT) does not require lengthy and complex thermo cycling or DNA purification, and can therefore deliver PCR-caliber results more quickly -- and in a broad range of settings. Alere i tests for Strep A, C. difficile, respiratory syncytial virus (RSV) and chlamydia / gonorrhea are currently in development.

Alere i Influenza A & B was launched earlier this year in Europe. Clinical trials for CLIA waiver of Alere i Influenza A & B have been completed and the Company expects to submit a CLIA waiver filing to the FDA in early Q3 2014. Clinical trials for Strep A have also been completed and the Company expects to file for 510k clearance in Q3 2014.

Tuesday, June 17, 2014

Cepheid Announces European Release of Xpert Carba-R, a Molecular Test for Rapid Detection of Carbapenemase-producing Gram-negative Bacteria

Cepheid announced the release of Xpert® Carba-R, an on-demand molecular test for rapid and accurate detection of carbapenemase-producing Gram-negative bacteria, to be marketed as a CE IVD product under the European Directive on In Vitro Diagnostic Medical Devices. The test runs on Cepheid's GeneXpert® System, the world's leading molecular diagnostic platform. Xpert Carba-R detects and differentiates genes encoding the most prevalent carbapenemases — reporting five gene families that comprise 68 known individual resistance genes, including KPC, NDM, VIM, OXA-48 and IMP-1.

"Carbapenemase-producing organisms were named for their ability to fight off carbapenem antibiotics — the last line of defense in our medical toolbox," said John Bishop, Cepheid's Chairman and Chief Executive Officer. "Xpert Carba-R provides healthcare institutions a much-needed tool for rapid and accurate detection of patients colonized with these multidrug resistant organisms to help prevent widespread outbreaks and determine the best infection prevention pathways."

Carbapenemase-producing (resistant) organisms, or CROs, include the Enterobacteriaceae, which is a family of bacteria that normally live in the digestive system, including organisms such as Klebsiella pneumoniae and Escherichia coli. They are part of normal human gut bacteria. However, carbapenemase producers also include Pseudomonas aeruginosa, Acinetobacter baumannii, and a variety of other healthcare-associated pathogens that have become resistant to the antibiotics known as carbapenems. Carbapenems are often referred to as the antibiotics of last-resort and are usually reserved for severe life-threatening infections caused by multidrug resistant organisms. All of these organisms are capable of harboring and spreading these carbapenem resistance genes.

The emergence and global spread of carbapenemase-producing organisms is of great concern to health services worldwide. These bacteria are often resistant to all beta-lactam antibiotics and frequently co-resistant to most other antibiotics, leaving very few treatment options.

"Detection of patients carrying carbapenemase-producing microorganisms, with differentiation among the five major families of resistance genes, can significantly impact infection control. With results in less than an hour, we have the advantage of rapid implementation of epidemiological measures to control the spread of these microorganisms," said Dr. Rafael Canton, Professor of Microbiology at the Hospital Universitario Ramon y Cajal, Madrid, Spain.

Carbapenemases of global importance include Klebsiella pneumonia carbapenemase (KPC), New Delhi metallo-β-lactamase (NDM), Verona integron-encoded metallo-β-lactamase (VIM), imipenemase metallo-β-lactamase (IMP), and oxacillinase-48 (OXA-48). As of 2014, KPC is the most widespread carbapenemase in the United States1 while OXA-48 is becoming the most important one in most European countries2.

"Like our other GeneXpert cartridges, Xpert Carba-R can be performed on a STAT basis — no waiting for batched results. Rapid identification of colonized patients allows healthcare institutions to begin immediate implementation of infection control measures to prevent spread in highly susceptible populations," said David Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "Active screening of high risk patients has the additional benefit of allowing clinicians to optimize isolation decisions and avoid the impact of unnecessary isolations."

Healthy people rarely get CRO infections, which are usually healthcare-associated infections found in patients in hospitals, nursing homes, and other healthcare settings. Patients whose care requires devices like ventilators, urinary catheters, or intravenous catheters, and patients who are taking long courses of certain antibiotics are most at risk for CRO infections.3

Xpert Carba-R begins shipping this month as a CE-IVD Mark product.

Monday, June 16, 2014

OraSure Technologies Announces New Co-Promotion Agreement for OraQuick HCV Rapid Antibody Test

OraSure Technologies, a market leader in point of care diagnostics, announced that it has entered into a Master Program Services and Co-Promotion Agreement with AbbVie under which AbbVie and OraSure will co-promote the Company's OraQuick® HCV Rapid Test in the United States. The product will be used to test individuals at-risk for hepatitis C (HCV). OraSure will be responsible for manufacturing and selling the product directly into all markets.

Under the agreement, OraSure has granted exclusive promotion rights to AbbVie for the OraQuick® HCV test in certain markets and will provide certain additional services in support of HCV testing. In exchange for the exclusive rights granted to AbbVie, OraSure will receive up to $75 million in exclusivity payments over the term of the agreement, which runs through December 31, 2019. In addition, upon achievement of certain performance-based milestones, OraSure will be eligible to receive additional payments annually over the life of the agreement. Further information regarding the agreement will be available in the Company's 8-K Report filed later today with the SEC.

According to the Centers for Disease Control and Prevention (CDC), HCV is the most common chronic blood-borne infection in the United States, with approximately 5 million people infected. It is estimated that one in 30 Baby Boomers (adults born between 1945 and 1965) have chronic hepatitis C and up to 75% of the people infected with HCV are unaware of their infection. The CDC, the U.S. Preventative Services Task Force (USPSTF), and the American Association for the Study of Liver Diseases (AASLD) have all issued guidance that recommends HCV testing for at-risk individuals including all Baby Boomers.

"We believe it is critical that at-risk individuals be tested for hepatitis C to prevent serious consequences from untreated infection," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "This new collaboration allows us to educate healthcare professionals and the patients they treat about hepatitis C and provide them with a very important rapid diagnostic tool."

The OraQuick® HCV test is the first and only FDA-approved and CLIA-waived point of care test for detection of HCV infection in at-risk individuals. The simple platform enables healthcare providers to deliver a diagnosis based on lab-accurate test results in 20 minutes, using fingerstick or venipuncture blood.

Listeria Rapid Bacteria Detector Developed

A new device designed to sample and detect foodborne bacteria is being trialled by scientists at the University of Southampton.

The Biolisme project is using research from the University to develop a sensor capable of collecting and detecting Listeria monocytogenes on food industry surfaces, thereby preventing contaminated products from entering the market.

Listeria monocytogenes is a pathogen that causes listeriosis, an infection with symptoms of fever, vomiting and diarrhoea, that can spread to other parts of the body and lead to more serious complications, like meningitis.

Transmitted by ready-to-eat foods, such as milk, cheese, vegetables, raw and smoked fish, meat and cold cuts, Listeria monocytogenes has the highest hospitalisation (92 per cent) and death (18 per cent) rate among all foodborne pathogens. Listeriosis mainly affects pregnant women, new-born children, the elderly and people with weakened immune systems.

Current techniques to detect the bacteria take days of testing in labs, but the new device aims to collect and detect the pathogen on location within three to four hours. This early and rapid detection can avoid the cross contamination of ready-to-eat food products.

Traditional methods of testing, where sample cells are cultivated in labs, are also flawed. 'Stressed' cells will not grow in cultures (and will therefore produce negative results) despite the bacteria being present, live and potentially harmful.

Alternative techniques, based on molecular methods, will detect all cell types, but don't differentiate between live and harmless dead cells, which can remain after disinfection.

The new device is designed to sample single cells and biofilms - groups of microorganisms where cells stick together on surfaces. Compressed air and water is used to remove the cells before they are introduced to an antibody. If Listeria monocytogenes is present, cells react with the antibody to produce a florescent signal, which is detected by a special camera.

Doctor Salomé Gião and Professor Bill Keevil from Southampton's Centre for Biological Science Unit have been studying Listeria monocytogenes biofilms under different conditions and will be testing the new prototype. "We researched biofilms under different stresses to find the optimum pressure to remove cells from different surfaces, without disrupting the cells themselves," says Dr Gião. "We also found that biofilms can form on surfaces even if they are covered in tap water.

"The scientific research we have carried out at the University of Southampton has been used by our Biolisme project partners to develop a device which will have major implications for the food industry. By making the process simpler we hope that testing will be conducted more frequently, thereby reducing the chance of infected food having to be recalled or making its way to the consumer."

The prototype sensor has been finalised in France and field trials are now underway to test the device before it is demonstrated in food factories.
José Belenguer Ballester, from project partner ainia centro tecnológico, added: "Biolisme has raised the expectations of food business operators because the devices being developed will allow rapid assessment of the cleanliness of manufacturing plants."