Sunday, October 15, 2017

Generex Announces Distribution Contract For Rapid 1-2-3® Hema HIV EXPRESS® in Chile

Generex Biotechnology Corporation today announced that its subsidiary, Hema Diagnostic Systems, LLC, has entered into an exclusive contract with Imerlab Sociedad Comercial Limitada  for the distribution and sale of the Rapid 1-2-3® Hema HIV EXPRESS® diagnostic test in the Republic of Chile.

Imerlab imports and distributes medical devices, reagents for clinical diagnosis and diagnostics products for private and public hospitals, clinical laboratories, pathology departments and research facilities utilizing a network of regional distributors throughout Chile, under the management of Juan Carlos Gonzalez Henriquez, its General Director.

The Rapid 1-2-3® Hema HIV EXPRESS® has been registered by the Chilean Ministry of Health and approved for sale there. Imerlab will have the exclusive rights to negotiate with both private entities and public institutions for the placement and sale of the product in clinical settings that require rapid point-of-care testing for HIV, not only in urban hospital and outpatient clinics, but also in parts of the country that have limited laboratory and testing resources.

The Rapid 1-2-3® Hema HIV EXPRESS® is designed for quick and reliable point-of-care testing with minimal procedural steps. It is performed by drawing up a single drop of blood, procured by a simple finger stick, onto a collection pad which is then fitted with a reagent pod which activates the immunological reaction to determine if HIV antibodies are present or absent. Results are ready within 15-30 minutes and are read visually. The test is highly accurate in detecting antibodies to HIV and has the benefits of low cost for resource poor settings, simplicity in usage which reduces testing error, availability of results in real-time that allows the clinician to make on-site treatment recommendations and minimal training requirements for clinic staff and personnel. Its utility is strongest in medium and poor income countries.

HIV in Chile is increasing at an alarming rate. According to a report issued by the Joint United Nations Programme on HIV/AIDS (UNAIDS) in July, 2017, Chile is the Latin American country with the highest rate of new HIV infections among adults since 2010, with new cases being diagnosed at a 34% rate increase between 2010 and 2016.

These figures substantiate the urgent necessity for improved and rapid diagnostic techniques and tests for the identification and prompt treatment of HIV in Chile.

Dr. Harold G. Haines Ph.D., the President and CEO of Hema Diagnostic Systems, stated; “We welcome the addition of Imerlab into our growing list of international partners who sell and distribute the Rapid 1-2-3® Hema HIV EXPRESS®. Imerlab is especially positioned to bring much needed rapid testing capability for HIV into Chile and we look forward to helping them in the ongoing effort to diagnose HIV and AIDS, with the ultimate goal of reducing illness and death due to AIDS in that country.”

GenePOC Launches its new GenePOC™ GBS DS Test

GenePOC announces the launch of its Group B Streptococcus Direct Swab (DS) molecular test in Europe

GenePOC, Inc. (GenePOC), a member of the Debiopharm Group, is proud to announce the launch of its 2nd assay this year, GenePOC™ GBS DS, for use on the revogene™ instrument. GenePOC GBS DS at intrapartum will aid to minimize the risk of GBS transmission from the mother to their newborn and will help to optimize antibiotic stewardship.

About GBS screening in Europe

Still today, GBS is the leading cause of infection in infants worldwide with a fatality rate between 4-6%. There is an unmet clinical need as many countries have introduced guidelines to prevent early onset disease in newborns while other countries do not follow any guidelines yet.

In the current clinical strategy, the detection of Group B Streptococcus colonization in pregnant women is performed between 35 and 37 weeks of gestation and, if a positive result is obtained, an intrapartum antibiotic prophylaxis (IAP) is administrated to the mother. However, studies have shown that up to 61, 4% of term infants with GBS disease are born to women who have been falsely diagnosed negative or whose colonization status has changed from the time of antenatal testing to the time of delivery.

"Intrapartum GBS testing is superior to antenatal testing at week 35-37. However, this requires very fast and easy methods. The GBS DS assay from GenePOC allows sensitive diagnosis of GBS just prior to delivery, making intrapartum GBS screening possible and resulting in optimized detection of patients at risk," said Prof. Dr. med. Lutz von Müller from Christophorus-Kliniken, Coesfeld, Germany. Dr Von Müller studied the detection of Group B Streptococcus (GBS) colonization before delivery and compared the new GenePOC molecular system to culture.

"What we are passionate about at GenePOC is to eliminate the highly debilitating effects of early onset diseases which include meningitis, pneumonia and in some cases death. In launching our new GenePOC GBS DS assay, we will be directly addressing that unmet clinical need. Our goal is to work closely with our distribution partners to improve the standard of care while decreasing the occurrence of early onset Group B Streptococcal disease in infants," said Patrice Allibert, PhD, CEO of GenePOC. "The GenePOC offer is a breakthrough solution for testing GBS carriage while the mother is in labor. Compared to alternatives already on the market, we excel in providing actionable and highly reliable results to clinicians and women," Patrice Allibert continued.

About revogene 

The revogene is an automated and standalone instrument.  It enables testing of single-use proprietary microfluidic cartridges, or PIEs, with fluorescence-based real-time polymerase chain reaction platform to deliver an accurate diagnosis. revogene, has been award winning for its innovative technology and design.

The revogene instrument is both CE-Marked and FDA cleared.

About GenePOC

GenePOC is a company that specializes in the development of diagnostic devices which enable the prevention and detection of infectious diseases.

The company aims to become the market leader in the rapid microbial testing at the point of care (POC). GenePOC is a member of the Debiopharm Group.

GenePOC's revogene instrument is available in the US and EU markets with a rapidly expanding test menu.

About Debiopharm Group 

Debiopharm Group™ is a Swiss-headquartered global biopharmaceutical group including five companies active in the life science areas of drug development, GMP manufacturing of proprietary drugs, diagnostic tools and investment management.

Abacus Diagnostica Receives CE Mark for the World's Fastest Molecular Tests for Norovirus GI and GII

Abacus Diagnostica Oy announces that it has received the CE mark for the GenomEra® Norovirus. The IVD test is the world's fastest molecular test for the detection and differentiation of norovirus genogroups I and II. The new test runs on the fast, cost-effective and automated GenomEra CDX platform.

The proper diagnostics plays a key role in preventing norovirus infections, as there are no vaccines or preventive medicine available. The low infectious dose, short incubation period and environmental persistence makes noroviruses extremely contagious. Norovirus outbreaks lead easily to ward, school or restaurant closure. Globally, annual societal costs of norovirus infections are estimated to be $60.3 bn1.

"Until recent years Norovirus diagnostics has been challenging and most of the cases are still diagnosed by clinical symptoms. Molecular tests are the only in vitro diagnostic tests, which can detect virtually all norovirus variants and are sensitive enough to detect all infections despite the severity. GenomEra enables adaptation of quick and reliable norovirus diagnostics also in places with limited resources, and is so easy, that it can be used without any experience of molecular methods" Says Erno Sundberg, CEO of Abacus Diagnostica.

"Our team has once again done great work and as a result we are now proud to launch the first commercial molecular norovirus test directly from stool without RNA extraction. We have now successfully applied our proprietary chemistry for the detection of RNA viruses with one the most challenging tests to make. The product portfolio extension for other RNA viruses such as influenza is now a straightforward process."

New distributors

Abacus Diagnostica has improved the availability of GenomEra products by signing new distribution agreements. The most important one has been signed with UK based Launch Diagnostics, a leading supplier of diagnostic solutions and innovations.

"Launch Diagnostics Ltd is pleased to be partnering with Abacus Diagnostica to supply the GenomEra CDX instrument and Norovirus kits in the UK, Ireland, France and Benelux. Norovirus outbreaks are major concern - by the 8th of September, Public Health England has recorded 215 norovirus outbreaks during 2017, and which 93% of those has led to ward/bay closure. Such outbreaks can be crippling to hospitals so rapid, reliable diagnosis with a test like the GenomEra Norovirus kit can dramatically improve patient care and save hospitals money." Says Launch Diagnostics' Marketing Director & Directrice France et Benelux, Veronique Petit.

About Abacus Diagnostica

Abacus Diagnostica Oy is a Finnish molecular diagnostic company, which has commercialized its proprietary GenomEra® platform. GenomEra CDX system has proven to be one of the fastest, easiest-to-use and the most cost-effective automated solution for molecular diagnostics (MDx) of infectious diseases. GenomEra is suitable also for small to mid-size customers without any prior experience in MDx. Abacus' vision is to provide cost-effective and easy-to-use products to enable MDx also in resource and capability limited settings.

Market Ready HIV Self-Test Gets the Thumbs Up from the European Union

The EU has awarded a CE Mark to an HIV self-test, developed by world-leading diagnostics developer, Atomo Diagnostics, Sydney, Australia. The world’s first at-home device detects the presence of Human Immunodeficiency Virus (HIV) antibodies, to give a reliable diagnosis. Atomo Diagnostics is now seeking commercialisation and distribution partners to bring the test to Europe and other global markets.

The virus causes AIDS, a devastating disease of the immune system. It infects immune cells, impairs their function and puts the individual at risk of opportunistic infections and cancers. When an individual has had one or more of these infections or HIV-related cancers, they have acquired immunodeficiency syndrome (AIDS).

Currently, diagnosis requires individuals to provide a sample at a hospital or clinic. This system is unpopular, as it is expensive – and not always covered by insurance – and secrecy is difficult to guarantee, meaning uptake is relatively low. Atomo’s HIV Self Test is convenient, discrete and easy to use. A finger prick collects a drop of capillary blood. A buffer is then added and within 15 minutes, results should be visible.

Atomo’s kit complements current research searching for a cure to the deadly virus. For example, Abivax’s ABX464 significantly reduced the viral reservoir in patients during a Phase IIa trial, while Sanofi is developing a ‘super-antibody’ that can kill 99% of HIV strains. As Atomo’s new technology improves access to HIV diagnosis, more people will be able to get the information they need to do something about the condition.

Self-testing is seen as a crucial step to achieving the goals of the 90-90-90 initiative. The initiative hopes to ensure that 90% of individuals with HIV know their status, receive antiretroviral therapy (ART), and those on ART will be virologically suppressed, all by 2020. Although a massive ask, working towards these targets is a worthy use of resources as it would change the lives of millions of people around the world.

Atomo has already developed rapid diagnostic tests for use in hospitals and clinics, but its latest device takes HIV diagnosis into the homes of the people that need it. If uptake can be increased, people unknowingly suffering from the disease can fight it sooner, which would change their lives.

Roche C. difficile Assay Among FDA-Cleared Tests in September

The US Food and Drug Administration cleared Roche's Cobas Cdiff Nucleic acid test last month for the detection of the toxin B (tcdB) gene of toxigenic Clostridium difficile, the agency said on its website.

The test was among several that received 510(k) clearance from the FDA in September, including tests by Radiometer Medical and Sanguina.

Roche's test, which is for use on the company's Liat platform, is an automated qualitative in vitro diagnostic test leveraging real-time PCR to detect the tcdB gene of toxigenic C. difficile in soft or liquid stool specimens obtained from patients suspected of having C. difficile infection. The test is intended as a diagnostic aid in conjunction with clinical and epidemiological risk factors, according to a document filed with the FDA.

The Cobas Cdiff detects tcdB target-specific and IC-specific oligonucleotide sequences. tcdB is a major toxin implicated in C. difficile pathogenesis and allows for the differentiation of toxigenic C. difficile strains from non-toxigenic strains, Roche said in its FDA document. It added that primers and probe oligonucleotide sequences were designed to detect C. difficile-conserved sequences without cross-reacting with other Clostridium genus organisms, or other organisms found in normal gut flora.

The test uses silica magnetic particle-based nucleic acid extraction and TaqMan probe-based real-time PCR amplification and detection. According to Roche, no reagent preparation or additional steps are required other than adding the biological sample in media to the Cobas Cdiff assay tube.

Also in September, Radiometer Medical, part of Danaher, received FDA clearance for its AQT90 Flex analyzer, AQT90 Flex Myo Test kit, and AQT90 Flex CKMB Test kit.

The AQT90 Flex is an immunoassay instrument, which leverages quantitative determination of time-resolved fluorescence to assess the concentrations of clinically relevant biomarkers in whole-blood and plasma specimens to which an anticoagulant has been added. The platform is intended for use in point-of-care and laboratory settings.

The AQT90 Fly Myo Test kit is an IVD assay for quantitatively determining myoglobin in EDTA or lithium heparin whole-blood or plasma specimens on the AQT90 Flex instrument. The assay is for aiding in the diagnosis of heart disease.

The AQT90 Flex CKMB Test kit is an IVD assay for quantitatively determining creatine kinase isoform MB in DETA or lithium heparin whole-blood or plasma specimens on the AQT90 Flex analyzer. It is intended as an aid in diagnosing myocardial infarction.

The FDA also provided 510(k) clearance for Sanguina's AnemoCheck, a semiquantitative colorimetric assay for determining total hemoglobin and calculated hematocrit in whole blood. The rapid diagnostic can be used in the POC, clinical, and doctor office laboratory setting.

Other assays that received FDA clearance last month include Cepheid's Xpert Xpress Strep A test, Hologic's Panther Fusion Flu A/B/RSV assay, and Alere's i Influenza A & B test.

Friday, October 06, 2017

Bruker Introduces New Products for Diagnosis and Susceptibility Testing of Invasive Fungal Diseases

At the Trends in Medical Mycology conference, Bruker today introduces the new, CE-IVD marked Fungiplex® Candida fast diagnostic assay, a multiplex real-time PCR test for the rapid identification of the most common pathogens associated with invasive candidiasis.  The new Fungiplex Candida assay does not require any culture steps, and typically gives results in just 2-3 hours directly from patient blood, plasma or serum samples.

Bruker also introduces the CE-IVD marked MICRONAUT®-AM (antimycotics) test plate for the automated or manual antifungal susceptibility testing (AFST) of yeasts from cultures. MICRONAUT®-AM is from the product range of recently acquired MERLIN Diagnostika GmbH, a leader in speciality susceptibility testing products across a range of human and veterinary application areas.

The Bruker microbiology portfolio is led by the MALDI Biotyper (MBT) platform for fast proteomic fingerprinting, a market-leading family of products providing rapid, broad-based molecular identification of microorganisms like bacteria, yeasts and fungi from cultures.  Both new IFD tests further expand Bruker's microbiology business, and re-inforce Bruker's additional focus on rapid identification of invasive fungal diseases, followed by antifungal susceptibility testing.

With the previous launch of the CE-IVD marked Fungiplex Aspergillus fast identification assay at ECCMID 2017, Bruker announced a new focus on rapid detection of fungal infections in at-risk patients, especially the immuno-compromised, allowing the development of effective treatment strategies to deliver improved patient outcomes.  Such IFD diagnostic tools have the additional benefits of reducing prophylactic antifungal drug treatments, reducing the likelihood of antifungal resistance and bringing down the overall cost of care for at-risk patients.

The new Fungiplex Candida assay is a multiplex real-time PCR test for the most common pathogens associated with invasive candidiasis (IC), a major cause of morbidity and mortality in health care environments. The sensitivity of blood culture for diagnosing IC is low, typically reported at 50%, and is coupled with slow turnaround times of 2-3 days.  Delayed diagnosis and delays to the initiation of appropriate treatment are associated with high mortality and extended hospital stays.  The Fungiplex Candida assay enables the early identification of Candida infection without the need for blood culture and is validated against DNA extracted from whole blood, serum and plasma.  Fungiplex Candida detects the main causative pathogens of IC: C. albicans, C. parapsilosis, C. tropicalis, C. dubliniensis, and differentiates C. krusei and C. glabrata.

The Fungiplex Candida assay reports the identification results in less than 2 hours from DNA extraction and displays excellent clinical performance, in a user friendly format compatible with existing laboratory equipment. This assay delivers the potential to aid earlier diagnosis, reduce hospital spend and improve patient outcomes.

Dr. Lewis White, Principal Clinical Scientist at NPHS Microbiology Cardiff, commented on the new Fungiplex Candida assay: "Fungal diseases such as invasive candidiasis pose an extremely serious healthcare risk to immunosuppressed patients, especially within the intensive care unit. Current diagnostic methods, including culture, struggle due to low sensitivity. Expensive prophylactic and empiric drug use is common, whereas PCR, as a key component of combined biomarker surveillance strategies, has the potential to prevent the overuse of unnecessary antifungals and allows the targeted use of antifungal drugs. Bruker's Fungiplex Candida real-time PCR assay, when combined with appropriate recommendations on DNA extraction, provides a standardised approach that displays excellent analytical performance and clinical sensitivity and specificity, with the potential to improve the diagnosis and treatment of at-risk patients. With the standardization of Candida PCR previously lacking, this new commercial option provides users with a validated and quality controlled alternative to be used in combination with serological tests."

The principle of the MICRONAUT™ system for specialty antimicrobial susceptibility testing is the phenotypic detection of microbial growth inhibition in the presence of antibiotics.  Its microdilution procedure is a standardized, globally accepted reference method for the determination of minimal inhibitory concentrations (MICs).  The MICRONAUT-AM plate allows for the antifungal susceptibility testing (AFST) of nine antimycotics (including anidulafungin, caspofungin and posaconazol) in up to eleven concentrations, and provides a standardized workflow for analysis with visual or photometric interpretation.

Dr. David Eustace, Head of IFD Business Unit at Bruker Daltonics, added: "The combination of the Fungiplex Candida and Fungiplex Aspergillusreal-time PCR assays for the rapid detection of IFDs without culture, coupled with the introduction of MICRONAUT-AM high-performance MIC-based antimycotic susceptibility products, complement the existing MALDI Biotyper product family in the field of invasive fungal disease testing.  This expanding IFD portfolio has the capability of meeting a wide range of customer needs, delivering high quality solutions to improve patient outcomes at every stage of the IFD treatment pathway."

About the Bruker MALDI Biotyper (MBT) Platform

The MALDI Biotyper family of systems enables molecular identification 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.  Many published studies have highlighted the greater accuracy and lower cost offered, as well as typically much faster time-to-result (TTR).

Applications of various MALDI Biotyper solutions include clinical routine microbial identification, 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 the past few years due to the accuracy, speed, extensive species coverage, ease of use and cost effectiveness of the system.  Traditional biochemical techniques detect different metabolic properties of microorganisms, can take many hours or even days for completion, and they often lack specificity.

The robust MALDI Biotyper 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, 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.  RUO versions of the MALDI Biotyper allow selected, high-value antimicrobial resistance tests.

Hologic Panther Fusion Flu A/B/RSV Assay Cleared by FDA

Hologic, Inc. announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Panther Fusion® Flu A/B/RSV assay running on the new Panther Fusion® system.

The Panther Fusion is available as a full system or the Panther Fusion module can be attached to existing Panther systems in the field to extend testing capabilities. Specifically, the Panther Fusion adds the capacity to run PCR (polymerase chain reaction) assays in addition to tests based on TMA (transcription-mediated amplification), the proprietary Hologic chemistry that powers the Company's Aptima® brand.

"Consolidating testing remains a key focus of our clinical laboratory customers," said Tom West, president of the Diagnostic Solutions Division at Hologic. "Offering multiple chemistries on a single platform expands menu while allowing labs to further consolidate testing and meet efficiency goals."

The Panther Fusion system retains all the key benefits of the Panther platform, including full sample-to-result automation, the ability to run multiple tests from a single sample, random access sample processing, continuous loading, and STAT capabilities. Additional benefits include a higher throughput of up to 335 Panther Fusion tests in eight hours, or up to 500 Fusion and Aptima tests.

In addition to the current clearance of the Panther Fusion® Flu A/B/RSV assay, two additional respiratory panels, the Panther Fusion Paraflu assay and the Panther Fusion AdV/hMPV/RV (adenovirus/human metapneumovirus/rhinovirus) assay, are under review by the FDA. These assays are not currently available for sale in the United States.

Once all three Panther Fusion respiratory assays are cleared, they will offer a modular approach to testing via the ability to run one, two or all three assays from a single patient specimen. The Panther Fusion assays also utilize ready-to-use reagents, which offer up to 60-day on-board stability.

"We have heard from customers that many panels currently on the market are too large, requiring them to run up to 20 or more targets when perhaps a physician has only requested three or four," said West. "Not only is this time-consuming for the lab, it is also not cost-effective. By offering three smaller panels focused on the tests most frequently requested, we will offer labs maximum flexibility to design test runs to meet specific needs."

"Hologic has long-standing expertise in flu extending back to the introduction of ProFlu+, the first FDA-cleared Flu A/B/RSV assay on the market in 2008," said West. "This expertise has translated to the development of a test with excellent performance, and that test is now available on our integrated platform, which fully automates all aspects of testing, from sample to result."

The Panther Fusion system substantially reduces hands-on time for laboratories by providing random and continuous access with rapid turnaround time. The new Panther Fusion PCR-based assays, combined with select Aptima TMA assays, make the Panther Fusion system the only instrument worldwide that combines TMA, real-time TMA, and real-time PCR with full sample-to-result automation.

The Panther Fusion system and Panther Fusion Flu A/B/RSV, Paraflu, and AdV/hMPV/RV assays have also been CE-marked for diagnostic use and are commercially available in Europe.

Cepheid Xpress Strep A Test Clears FDA

Cepheid's rapid assay for Group A Strep has received clearance from the US Food and Drug Administration. The Xpert Xpress Strep A test is an automated real-time PCR assay that takes as little as 18 minutes to detect Streptococcus pyogenes in DNA from patient throat samples.

The test also "allows patients and their healthcare providers to expect a definitive diagnosis at the point of care, and to avoid the need for lengthy and cumbersome confirmatory bacterial cultures," said Cepheid's Chief Medical and Technology Officer David Persing in a statement. The assay eliminates requirements for culture confirmation of negative results, unless clinical symptoms persist or there is an occurrence of acute rheumatic fever.

This is the third assay on the Xpert Xpress line that was first described by the firm in 2015 and also includes Xpert Xpress Flu and Xpert Xpress Flu/RSV. Xpress tests can be run on the Cepheid GeneXpert molecular diagnostics platform, which has an installed base of more than 11,000 systems in 182 countries. The tests are also slated to run on Cepheid's point-of-care system, Omni, although Cepheid has delayed Omni's development in order to expedite the Xpress tests on its existing GeneXpert systems.

Although antibiotic treatment of acute pharyngitis, or "strep throat," is often initiated inappropriately for illness caused by viruses, a lack of guidelines from professional societies regarding molecular testing for Group A Strep testing has been previously thought to have impacted uptake of rapid, near-patient testing from other firms.

Accurate Salmonella Test Gives Veterinarians Quick Results

A new test allows accurate, rapid testing for Salmonella, bacteria that represent one of the leading causes of food-borne illness across all regions of the world. Salmonella can infect animals as well as people, with commonly reported cases of people falling sick after handling pets and livestock.

Tests that used to take days now take 24 hours, with a hundredfold improvement in detection for at least one type of Salmonella – called Salmonella Dublin – that is an emerging concern and is difficult to grow in culture, making diagnosis difficult.

The new method, first developed for automated food safety testing and then adapted by Cornell scientists for a wider range of sample types, can detect the bacteria from environmental and clinical samples, including swabs, feces, milk and blood.

The test improves diagnosis time from as many as five days using current procedures, according to a recent study published Sept. 1 in the Journal of Veterinary Diagnostic Investigation.

Fast diagnosis of environmental samples is important because clinics are forced to leave rooms vacant or trust their cleaning and disinfection protocols and put healthy animals in areas that could spread infection.

“Because we have this 24-hour turnaround time with the new test, there are veterinary hospitals and clinics that can test and get results rapidly and make sure they are not exposing other animals to Salmonella,” said Belinda Thompson, assistant clinical professor at the Animal Health Diagnostic Center and a senior author of the paper.

Fast clinical diagnoses also allow veterinarians to quickly quarantine an infected animal.

Salmonella Dublin is “host adapted” in cattle, meaning infected animals can become permanent or long-term carriers, putting herd mates, especially susceptible calves, at risk. This strain can infect people who may be exposed by contact with infected animals, by drinking raw milk, or by consuming other contaminated food products. In humans, Salmonella Dublin has higher hospitalization and fatality rates than other Salmonella types; it causes systemic infection of body tissues, similar to typhoid.

“Salmonella biosurveillance in veterinary facilities is critical because animals can shed the bacteria without showing clinical disease signs,” said Laura Goodman, a senior research associate in the Department of Population Medicine and Diagnostic Sciences and lead author of the study. Goodman added that the method described in the study is now available as an environmental testing program through the Animal Health Diagnostic Center.

The test was funded and developed in collaboration with the Food and Drug Administration (FDA) Veterinary Laboratory Investigation and Response Network. Cornell works closely with FDA scientists to evaluate and perform new methods that the government agency can share with other veterinary labs.

The study describes an important innovation: Choosing a type of broth culture that selectively provides the right nutrients to grow certain bacteria. The researchers chose a broth that would cover a wide range of Salmonella types, including Salmonella Dublin and others relevant to animal health. They then applied an advanced molecular detection system to screen the broth for small amounts of Salmonella DNA. Bacteria can be further characterized with whole genome sequencing.

“Salmonellosis can be a serious and costly disease of animals and people, and anything we can do to enhance diagnostic procedures to help control the pathogen is a good thing,” Thompson said.

Monday, October 02, 2017

Alere Receives FDA Clearance for Alere™ i Influenza A & B 2 Rapid Molecular Test

Alere Inc., a global leader in rapid diagnostics, today announced that its Alere™ i Influenza A & B 2 test has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for the detection of influenza A and B infection in children and adults.

Alere i Influenza A & B 2 is a second-generation rapid molecular assay, which delivers lab accurate results in less time, with the ability to report a positive result in as little as 5 minutes. This test will provide greater convenience with the addition of room temperature storage and reduced warm-up time for transport media samples. Alere i Influenza A & B 2 also offers increased sample flexibility with nasopharyngeal swabs now validated for direct use, as well as, in transport media.

Alere will shortly submit an application for CLIA (Clinical Laboratory Improvement Amendments) waiver of the Alere i Influenza A & B 2 test. Alere i testing applications have previously been CLIA-waived for Influenza A & B, Strep A and RSV.

"Our innovative Alere i platform leads the way in the rapid molecular segment with thousands of placements in hospitals, clinics, physician offices and other point of care settings. With this latest enhancement we now can offer 'early call out' of positive results on all three available applications, Alere i Influenza A & B 2, Alere i Strep A and Alere i RSV. In acute care settings, every minute counts when assessing symptomatic patients. 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 2 was established in a multi-center, prospective clinical study conducted at ten US trial sites during the 2016-2017 respiratory season, in which 1074 prospective nasal or nasopharyngeal swab specimens, collected from patients with influenza-like symptoms, were evaluated with Alere™ i, and compared to an FDA-cleared real-time Polymerase Chain Reaction (RT-PCR) test.

Alere has also expanded some of the features on the Alere i instrument with the introduction of bi-directional connectivity and an optional QC lockout function, to prevent testing of patient samples if QC testing requirements are not met, enhancing overall quality assurance.

The Alere i molecular platform was initially cleared for marketing by the FDA for the detection and differentiation of influenza A and B virus in June 2014, with Alere i Strep A receiving FDA clearance in March 2015 and Alere i RSV receiving clearance in October 2016. The Alere i Influenza A & B 2 test will be available for use in hospitals in time for the 2017-2018 respiratory season.