FDA Recommends Zika Test for All Blood Donations

The U.S. Food and Drug Administration (FDA) on Friday issued a recommendation for universal testing of donated whole blood and blood components for the Zika virus in the United States and its territories. The agency had recommended in February blood screening only in areas with active transmission of the virus.

In its announcement the FDA said:

"The FDA is updating its guidance after careful consideration of all available scientific evidence, consultation with other public health agencies, and taking into consideration the potential serious health consequences of Zika virus infection to pregnant women and children born to women exposed to Zika virus during pregnancy. Testing of donated blood is already underway in Florida and Puerto Rico, as well as in other areas, and it has shown to be beneficial in identifying donations infected with Zika virus. Expanded testing will continue to reduce the risk for transmission of Zika virus through the U.S. blood supply and will be in effect until the risk of transfusion transmission of Zika virus is reduced."

The FDA recommendations take effect immediately in Florida and Puerto Rico, with 11 states, mostly in the southeastern United States, added within four weeks. The rest of the country must implement the recommendations within 12 weeks.

The universal screening requirement is expected to generate about $30 million in sales for testing kits, with the majority of the spending to benefit Roche and Hologic Inc..

Earlier last week, medical diagnostics maker OraSure Technologies Inc. said that it had been awarded a $16.6 million contract to proceed with work on the company’s rapid tests for the Zika virus. The initial commitment under the contract totals $7 million, with options for up to $9.6 million in additional funds to pay for enhancements and clinical and regulatory activities.

Earlier this year, OraSure announced that it had begun a development program for rapid Zika assays on the OraQuick platform and that it was actively pursuing external funding to advance this program. The rapid Zika tests utilize the Company’s OraQuick technology platform, the same technology used in the OraSure’s rapid HIV, HCV and Ebola test kits.

The latest data from the U.S. Centers for Disease Control and Prevention (CDC) show that the Zika virus is actively being transmitted in 57 countries, including the United States. As of August 24, there have been 2,517 confirmed U.S. cases of the virus, of which 29 are actively transmitted cases, all of which occurred in two areas of Miami, Florida. Nearly 8,800 confirmed cases have been reported in Puerto Rico.

The Zika virus causes microcephaly, a birth defect that causes the baby’s head to be smaller than expected, compared with other babies of the same sex and age. According to the CDC, Zika can also cause other problems among fetuses and infants infected with Zika virus before birth, such as defects of the eye, hearing deficits and impaired growth. There have also been increased reports of Guillain-Barré syndrome, an uncommon sickness of the nervous system, in areas affected by Zika.

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BioFront Introduces the first ELISA Kit that Detects Zika Virus NS1 Protein Without Cross-Reactivity with Dengue Virus NS1.

BioFront Technologies introduced the very first ELISA kit that specifically detects Zika virus NS1 protein without cross-reactivity with Dengue virus NS1.

The MonoTrace Zika Virus NS1 ELISA saves time compared to Western blotting (quantifiable results in under 2 hours)  and represents a high-throughput yet cost-efficient alternative to RT-qPCR.

 The highly sensitive monoclonal antibody-based sandwich ELISA recognizes the 3 major ZIKV genotypes and specifically detects secreted NS1 in cell culture supernatants and intracellular NS1 in lysates.  Equipment requirements are minimal and assay time is less than 2 hours, the MonoTrace Zika Virus NS1 ELISA is the perfect tool for monitoring infection or screening antiviral therapeutics.

BioFront develops and markets rapid diagnostic products dedicated to food safety and life sciences.

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OraSure Technologies Granted HHS Award for Rapid Zika Tests

OraSure Technologies, Inc. has been awarded a contract for up to $16.6 million in total funding from the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response’s Biomedical Advanced Research and Development Authority (BARDA) to advance the Company’s rapid Zika tests.

The six-year, multi-phased contract includes an initial commitment of $7.0 million and options for up to an additional $9.6 million to fund the evaluation of additional product enhancements, and clinical and regulatory activities. The Company is expected to provide an update on guidance and timing during its next quarterly earnings call in November.

The rapid Zika tests utilize the Company’s OraQuick® technology platform, which is the same proven technology used in the Company’s rapid HIV, HCV and Ebola test kits. Although there are currently molecular tests available for Zika, the Company believes these tests have limited utility, because of the short window of time when viral RNA can be detected in patients. Because anti-Zika antibodies appear in the body soon after infection and are present in the body for longer periods than the virus, the Company believes there is a significant need and utility for a rapid Zika antibody test. In addition, currently available tests are conducted in a laboratory and the availability of a rapid test will minimize turnaround time of results for the healthcare provider and patient.

"We believe the availability of an accurate rapid Zika antibody test will be a valuable tool to address current and potential future outbreaks,” said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. “We are grateful to BARDA for making this funding available as it will enable us to complete clinical and other activities required to obtain regulatory approvals for this product.”

Earlier in the year, OraSure announced that it had engaged in a development program for rapid Zika assays on the OraQuick platform and that the Company was actively pursuing external funding to advance this program.

OraSure has a highly successful track record for developing and commercializing point-of-care tests that address critical disease states. Most recently, with the support of up to $10.4 million from BARDA, the Company developed the OraQuick Ebola Rapid Antigen Test which received U.S. Food and Drug Administration (FDA) Emergency Use Authorization for the use of the test with fingerstick blood and cadaveric oral fluid samples. The Company also developed the only FDA approved rapid antibody test for hepatitis C, the OraQuick® HCV Rapid Antibody Test, and the first FDA approved rapid test for HIV, the OraQuick ADVANCE® HIV-1/2 Antibody Test. The Company has also developed the first and only HIV self test approved by the FDA for use by consumers, the OraQuick® In-Home HIV Test.

The Zika and Ebola projects have been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600028C and Contract No. HHSO100201500009C, respectively.

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Potential New Test to Detect Serious Bacterial Infections Including Meningitis and Sepsis

Scientists have identified two genes that are switched on only when a child is suffering from a bacterial infection. This could allow doctors to quickly distinguish between a viral or bacterial illness, and identify early cases of potentially deadly infections.

The international team of scientists, led by researchers at Imperial College London, hope to now use the findings to develop a rapid test for use in hospitals and doctors' surgeries.

This would enable conditions such as meningitis, septicaemia or pneumonia - which are caused by bacterial infections - to be caught more rapidly. Such a test would also prevent children with viral infections being unnecessarily prescribed antibiotics, which are only effective against bacteria. This would help combat the growing threat of antibiotic resistance.

At the moment, when a child arrives at a surgery or hospital with fever, doctors have no quick method of distinguishing whether the child is suffering from bacterial or viral illness. Diagnosis relies instead on taking a sample of blood or spinal fluid, and seeing if bacteria grow in this sample. However this can take more than 48 hours.

Differentiating between viruses and bacteria is crucially important. Although viral infections are much more common than bacterial infections, the latter are far more dangerous, and lead to a deadly conditions such as meningitis, septicaemia and pneumonia.

Professor Michael Levin, from Department of Medicine at Imperial College London, who led the study explained: "Fever is one of the most common reasons children are brought to medical care. However every year many children are sent away from emergency departments or doctors' surgeries because the medical team thinks they have a viral infection, when in fact they are suffering from life-threatening bacterial infections - which are often only diagnosed too late. Conversely, many other children are admitted to hospital and receive antibiotics because the medical team are unable to immediately exclude the possibility of a bacterial infection - but in fact they are suffering from a virus."

Professor Levin, from the section for paediatric infectious diseases at Imperial added: "Although this research is at an early stage, the results show bacterial infection can be distinguished from other causes of fever, such as a viral infection, using the pattern of genes that are switched on or off in response to the infection. The challenge is now to transform our findings into a diagnostic test that can be used in hospital emergency departments or GP surgeries, to identify those children who need antibiotics."

In the study, published in the Journal of the American Medical Association (JAMA), the scientists studied 240 children with an average age of 19 months, who arrived at hospitals with fever across the UK, Spain, the Netherlands and the USA. Once the children were diagnosed with a viral or bacterial infection using traditional methods, the team studied the genes that had been switched on in the children's white blood cells. Using a method known as RNA micro arrays, which measure changes in 48,000 genes simultaneously using only a small drop of each child's blood, the team found two genes are switched on in bacterial infections. Further tests showed these genes, called IFI44L and FAM89A, predicted a bacterial infection with 95-100 per cent accuracy.

Dr Jethro Herberg, senior lecturer in paediatric infectious diseases at Imperial, and co-author of the research added: "We are facing a growing threat from antibiotic resistant bacteria. A large proportion of antibiotic use is driven by our inability to reliably identify the small number of children with bacterial infection from the much larger number with viral infection, who do not need antibiotics. Fear of missing life-threatening infections like meningitis and septicaemia result in doctors often prescribing antibiotics and undertaking investigations such as lumber punctures just to be safe. A rapid test based on the two genes we have identified could transform paediatric practice, and allow us to use antibiotics only on those children who actually have a bacterial infection."

Vinny Smith, Chief Executive of Meningitis Research Foundation added: "We are proud to have supported the research underpinning this study over a number of years, and we are grateful to our family members who took part. This latest development is very exciting. Bacterial meningitis and septicaemia can kill in hours, and can leave survivors with life-changing after effects. Giving health professionals the tools to rapidly determine whether an infection is bacterial or viral will enable faster detection and treatment of meningitis and septicaemia."

The research team are now working on further studies to confirm the findings in larger numbers of children.

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Regeneron Wins Funding from BARDA toward MERS Therapies

Regeneron Pharmaceuticals said today it will manufacture and study two antibody therapies for potential prevention and treatment of Middle East respiratory syndrome (MERS) under an up-to-$8.9 million agreement with the U.S. Biomedical Advanced Research and Development Authority (BARDA).

BARDA, an agency of the U.S. Department of Health and Human Services (HHS), agreed to provide the funding to support packaging and labeling of the antibodies for human use, the preparation and submission of an IND application with the FDA, and a National Institutes of Health (NIH)-conducted clinical trial in healthy volunteers.

Last year, Regeneron researchers published a paper in Proceedings of the National Academy of Sciences (PNAS) disclosing how its proprietary VelociGene® and VelocImmune® technologies enabled rapid identification and preclinical validation of the MERS antibody candidates.

The MERS antibodies are subject to Sanofi opt-in rights for development and commercialization, having been discovered and developed pursuant to Regeneron's antibody discovery and preclinical development agreement with the pharma giant.

There are no medicines or vaccines approved by the FDA to treat or prevent MERS.

Regeneron and BARDA agreed in September 2015 to advance a potential Ebola therapy discovered and developed at Regeneron using VelociGene and VelocImmune, with HHS agreeing to provide initial funding of approximately $17 million to support preclinical development and antibody manufacturing.

The investigational Ebola therapeutic recently entered a Phase I human clinical study, Regeneron said, and has received the FDA’s Orphan Drug Designation.

“In addition to the programs in MERS and Ebola that we are advancing with BARDA, we are also quickly progressing a preclinical program targeting the Zika virus,” Neil Stahl, Ph.D., Regeneron evp of R&D, said in a statement.

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HHS Awards DiaSorin Group to Develop Rapid, High-Capacity Zika Diagnostic Laboratory Test

The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response today announced a $2.6 million agreement with DiaSorin Group, an Italy-based company with U.S. offices in Stillwater, Minnesota, to further develop a Zika virus test that may help physicians determine more quickly whether a patient was infected recently with Zika virus.

“Accurate, rapid Zika diagnostic tests to determine whether someone recently has been infected are critical to ensuring the best health outcomes during the current outbreak,” said Dr. Richard Hatchett, acting director for ASPR’s Biomedical Advanced Research and Development Authority (BARDA). “Identifying Zika cases more quickly helps people take steps to avoid additional transmission that much sooner, which helps protect pregnant women and others at risk of Zika infection.”

The automated laboratory test being developed by DiaSorin uses the company’s LIAISON XL system which can test up to 120 samples at one time and generate results within an hour. Such rapid, high capacity diagnostic tests are urgently needed in the global fight against Zika.

DiaSorin’s test is a serological test for Zika. Serological tests look for antibodies produced by the body’s immune response to viruses. The body produces the earliest response to the Zika virus beginning approximately two weeks after infection and up to three months later. Serological tests are critical in determining whether someone recently was infected with Zika because most people who are infected with the virus do not develop clinical symptoms and are thus unlikely to seek testing while the virus is present in their blood, which other tests can detect.

The contract supports the development of the diagnostic test, design improvements that may be needed, manufacturing preparations and clinical trials that could support its application for FDA clearance.

BARDA is seeking to advance several diagnostic tests for Zika to help improve their availability and potentially lead to lower costs for patients.

Only one in five people infected with Zika develop symptoms and for those that do, the illness usually is mild. The most common symptoms – fever, rash, joint pain, and conjunctivitis, or red eyes— typically last for several days to a week. People typically do not get sick enough to go to the hospital, and they very rarely die from Zika infection. For these reasons, many people might not realize they have been infected. However, Zika virus infection during pregnancy can cause serious birth defects, including microcephaly and other severe fetal brain defects.

In the absence of congressional funding for the Zika response, HHS has repurposed $374 million from other programs to fund domestic Zika preparedness and response activities. As of August, HHS agencies have obligated $231 million of these repurposed funds. ASPR’s BARDA received $85 million of these reprogrammed funds, and with today’s award, BARDA has obligated $43.9 million of these reprogrammed funds to develop Zika vaccines, diagnostics, blood screening tests, and pathogen reduction technologies with private sector partners. In addition, ASPR is providing Zika-positive blood samples to help developers validate the accuracy of new diagnostic tests.

Advancing the development of Zika diagnostics is part of BARDA’s integrated portfolio for the advanced research and development, innovation, acquisition, and manufacturing of medical counter measures — including vaccines, drugs, diagnostic tools, and non-pharmaceutical products — to public health emergency threats. These threats include chemical, biological, radiological, and nuclear agents, pandemic influenza, emerging infectious diseases, and antimicrobial resistance.

ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security. HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.

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Alere Receives FDA Clearance for Alere™ i RSV Rapid Molecular Test

Alere Inc., a global leader in rapid diagnostics, today announced that its Alere™ i RSV test has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for the detection of RSV infection in children and adults. Following Alere™ i Influenza A & B and Alere™ i Strep A, Alere i RSV is the latest testing application on the Alere i platform and is the first molecular test that can be used at the point-of-care to detect RSV in 13 minutes or less.

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

"Our innovative Alere i platform now allows for the rapid molecular detection of RSV, Influenza A & B and Strep A," said Avi Pelossof, Alere Global President of Infectious Disease. "The availability of clinically meaningful results in an actionable timeframe empowers clinicians to deliver prompt and appropriate patient care. We are excited to continue our ground-breaking innovation on this platform with multiple new analytes progressing well through product development."

In acute care settings, every minute counts when assessing symptomatic patients. Arming healthcare personnel with a simple to use point-of-care RSV test that offers speed and molecular accuracy facilitates early and appropriate supportive care, the avoidance of unnecessary antibiotic treatment, and the rapid initiation of infection control measures to help control the spread of this highly contagious and potentially life-threatening infection.

About the Alere i RSV test

Alere i RSV detects the RSV virus in nasopharyngeal (NP) swab samples using Alere's proprietary Molecular In Minutes™ isothermal nucleic acid amplification technology (iNAT). Alere i RSV is significantly faster than conventional polymerase chain reaction (PCR) tests delivering results in 13 minutes or less.

In clinical performance studies, the overall sensitivity and specificity of Alere i RSV using direct NP swab samples was 98.6% and 98.0%, respectively, versus PCR. With Viral Transport Media (VTM) samples, the sensitivity and specificity of Alere i RSV was 98.6% and 97.8%, respectively, versus PCR.

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. The Alere i RSV test will be available for use in hospitals in time for the 2016-2017 respiratory season.

About Respiratory Syncytial Virus (RSV)

RSV is a respiratory virus that infects a person's lungs and breathing passages.1 It is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia in children under one year of age.2 In the U.S., almost 58,000 children under the age of five with RSV infection are hospitalized annually.3 Premature infants and young children with congenital heart or chronic lung disease or with compromised immune systems due to a medical condition or medical treatment are at highest risk for severe cases of RSV, and may require mechanical ventilation.4 Because there is currently no treatment for RSV, infection control strategies are focused on reducing transmission.

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Trichomonas Assay Receives FDA Clearance for Diagnosis of Common STD

Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received clearance from the United States Food and Drug Administration (FDA) to market its Solana® Trichomonas assay for the detection of nucleic acids isolated from clinician-collected vaginal swabs and female urine specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis, a sexually transmitted disease attributable to infection from the Trichomonas vaginalis parasite. The Solana® Trichomonas Assay is intended for use only with the Solana® instrument.

According to the Centers for Disease Control and Prevention (CDC), an estimated 3.7 million people in the United States have trichomoniasis. This disease is more common in women and, because only about 30% of those infected develop symptoms of trichomoniasis, most infected persons do not know that they carry the parasite. In pregnant women, Trichomonas infection is often associated with preterm delivery and low body weight in newborns. Genital inflammation is often associated with disease and can facilitate infection by other sexually transmitted pathogens, including HIV. Importantly, trichomoniasis can be cured with a single dose of antibiotics, emphasizing the need for rapid, highly sensitive tests that can detect this parasite and prompt immediate treatment.

The Solana Trichomonas assay is an easy-to-use, rapid molecular diagnostic test that has superb clinical accuracy. The assay requires no upfront extraction of DNA and generates an accurate result in approximately 30 minutes.

The Solana molecular platform leverages the Helicase-Dependent Amplification (HDA) technology that is resident in Quidel’sAmpliVue® molecular product line to generate a fast and accurate test result. Solana can process up to 12 patient samples in each 30-minute run, thereby providing time-saving workflow advantages to healthcare professionals in moderately complex settings.

“We are pleased to receive clearance for our Solana Trichomoniasis assay, as it has shown excellent performance with vaginal swab and urine samples from both symptomatic and asymptomatic patients. We believe that our test can play a vital role in quickly diagnosing this disease in the moderately complex setting, thereby creating opportunities for patient treatment and limiting its spread,” said Douglas Bryant, president and chief executive officer of Quidel Corporation.

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Neogen Develops AOAC Validated Campylobacter Test

Neogen Corporation has developed the quickest and easiest AOAC validated test to definitively detect Campylobacter.

ANSR® for Campylobacter is the fifth test available for Neogen’s innovative ANSR pathogen detection system, and will provide results after only 18 minutes of reaction time following sample preparation.

“The AOAC validation verifies the effectiveness of ANSR for Campylobacter's approach of using an aerobic enrichment when testing for Campylobacter. Traditional testing for the bacteria with microaerophilic enrichments can be very challenging, and lead to false negative results by killing any existing viable Campylobacter,” says Ed Bradley, Neogen’s vice president of food safety. “The well-received and validated ANSR system provides the food industry definitive test results, and much easier and quicker methodology. This introduction of ANSR for Campylobacter extends our ANSR product offering for the bacterial pathogens of greatest concern to the food industry, and will be very easy for laboratories to adopt, as it follows the same procedure of all our other ANSR kits.”

The results of the AOAC validation study provided evidence that the overall performance of the ANSR for Campylobacter is equivalent to the USDA-FSIS/MLG reference method. Internal and independent laboratory studies using chicken carcass rinse and turkey carcass sponge samples proved ANSR for Campylobacter to be an effective alternative for detection of Campylobacter jejuni, Campylobacter lari, and Campylobacter coli after 20 to 24 hours of enrichment in an aerobic or microaerobic atmosphere.

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Invisible Sentinel Develops New Spoilage Detection Tool for Winemakers

Invisible Sentinel, Inc., a global molecular solutions company providing first-in-class microbial detection tools, introduces vinoPAL — a new product for preserving wine quality.

Built on the company's signature Veriflow® platform, vinoPAL rapidly identifies the presence of spoilage organisms Pediococcus and Lactobacillus. The arrival of vinoPAL is a response to winemakers' request for a rapid, on-site detection tool for these spoilage organisms that can contribute to sluggish fermentations. Utilizing the same equipment and workflow as the flagship vinoBRETT test for Brettanomyces, this new assay expands winemakers' ability to respond to issues and manage quality proactively at the winery.

"This year has been about expanding our product portfolio to directly meet the needs of our established client partners," said Invisible Sentinel CEO Nicholas A. Siciliano, Ph.D. "We're hearing their concerns and addressing them head-on, with the entire industry in mind."

As harvest season approaches, winemakers have a heightened awareness of the potential for undesirable bacteria to enter the winery undetected. vinoPAL is a proactive measure for anticipating the financial impact of Pediococcus and Lactobacillus, and is sensitive even at low thresholds in juice and young wines. Proactive management of spoilage organisms saves time and money, and most importantly – preserves the value of wine.

"Identifying the presence of Lactobacillus as soon as possible is a critical concern for me," said Eric Baugher, vice president of winemaking at Ridge Vineyards in Cupertino, CA. "This organism can multiply rapidly, and before you know it the fermentation can become sluggish, with possibility of high volatile acidity being formed. Early detection with vinoPAL will allow us to intervene quickly and prevent the loss of wine quality."

Since launching their wine product portfolio in May 2014, Invisible Sentinel continues to work with industry-leading winemakers around the world to identify pain points in the winemaking process. Hundreds of winemakers across twelve countries are now using Veriflow technology to protect their brand and ensure their wine meets the most stringent quality standards.

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Luminex Corporation Receives FDA Emergency Use Authorization for Zika Virus Molecular Detection Assay

Luminex Corporation announced that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a multiplex nucleic acid test designed to detect Zika virus RNA in potentially infected patients using their blood serum, plasma, or urine (collected alongside a patient-matched serum or plasma specimen).

Designed by Luminex partner, GenArraytion, Inc., the xMAP® MultiFLEX™ Zika RNA Assay detects Zika viral RNA in serum, plasma, or urine (collected alongside a patient-matched serum or plasma specimen). The Zika virus can be detected in blood and urine, and in July 2016, the Centers for Disease Control and Prevention updated its guidance to clinicians to recommend serum and urine testing for specimens collected < 14 days after symptom onset. The xMAP® MultiFLEX™ Zika RNA Assay has not been FDA cleared or approved and is only authorized for use for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection.

The xMAP® MultiFLEX™ Zika RNA Assay is available for purchase by laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. The multi-target assay uses the Luminex® 100/200™ or MAGPIX® instrument, or other authorized instruments, to simultaneously test for six genetic targets of the Zika virus.

"We are pleased that our innovative xMAP MultiFLEX Zika RNA Assay has been granted Emergency Use Authorization by the FDA.  Together with our partner, GenArraytion, Inc., we have responded to this crisis and are currently in discussions with key public health, reference and hospital laboratories," said Nachum "Homi" Shamir, President and CEO of Luminex. "As a leader in multiplex diagnostic testing for infectious diseases, we are proud to help enable healthcare providers to rapidly detect Zika virus with this assay today, and we intend to expand our coverage to include a broader array of mosquito-borne disease agents in the future to aid in treatment decisions for potentially afflicted patients."

R. Paul Schaudies, CEO of GenArraytion, Inc. commented: "Luminex molecular assays simultaneously detect multiple Zika targets and can detect the disease-causing viral pathogen earlier than serology assays. We are excited to use the highly flexible Luminex platforms for the development of key emerging infectious disease markers."

About the FDA's Emergency Use Authorization (EUA)

The FDA can use the EUA to permit use, based on scientific data, of certain medical products in certain circumstances, including when there is a determination by the Secretary of Health and Human Services that there is significant potential for a public health emergency.

About xMAP® Technology

Luminex's xMAP® Technology combines advanced fluidics, optics, and digital signal processing with proprietary microsphere technology to deliver multiplexed assay capabilities. Featuring a flexible, open-architecture design, xMAP Technology can be configured to perform a wide variety of protein or nucleic acid assays quickly, cost-effectively and accurately.  xMAP technology enables multiplexing of biological tests (assays), reducing time, labor, and costs over traditional methods such as ELISA, western blotting, PCR, and traditional arrays. Systems using xMAP Technology perform discrete assays on the surface of color coded beads known as microspheres, which are then read in a compact analyzer. Using multiple lasers or LEDs and high-speed digital-signal processors, the analyzer reads multiplex assay results by reporting the reactions occurring on each individual microsphere.

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Roche Receives CLIA Waiver for cobas® Influenza A/B & RSV Test for the cobas® Liat®

Roche today announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance and CLIA (Clinical Laboratory Improvement Amendments) waiver for the cobas® Influenza A/B & RSV test for use on the cobas® Liat® System. Roche is the first manufacturer to extend the value of highly accurate CLIA-waived molecular testing beyond flu A/B and strep A to include Respiratory Syncytial Virus (RSV), a cause of more than 80% of acute lower respiratory tract infections in infants under one year of age.

"For young children and the elderly, it is essential to have a differential diagnosis for RSV and flu to ensure appropriate treatment within a short time frame after symptoms strike," said Uwe Oberlaender, Head of Roche Molecular Diagnostics. "This can be challenging with current turnaround times for lab-based test results. The cobas® Influenza A/B & RSV test provides lab-quality PCR results for flu and RSV in about 20 minutes, supporting a prompt, confident diagnosis to patients."

In the US, an average of 58,000 hospitalizations and 2.1 million outpatient visits in children under five years are attributed to RSV. A significant number is also seen in adults over 65 years with 177,000 hospitalizations and 14,000 deaths per year2. A quick detection and discrimination of flu and RSV enables clinicians to optimize patient management and antiviral treatment.

The cobas® Influenza A/B & RSV test is the third assay on the cobas® Liat® System to receive CLIA waiver, following the cobas® Strep A and cobas® Influenza A/B tests, which received CLIA waiver in May and September 2015, respectively. The cobas® Liat® Analyser and all three assays are FDA cleared and CLIA waived.

About the cobas® Influenza A/B & RSV test 

The cobas® Influenza A/B & RSV test uses real-time PCR (polymerase chain reaction) technology to detect and differentiate influenza A virus RNA, influenza B virus RNA and respiratory syncytial virus (RSV) RNA in about 20 minutes. It targets well-conserved regions of influenza A, influenza B and RSV RNA to provide broad strain coverage and has been validated on over 40 commonly found strains of influenza A and B and seven commonly found strains of RSV.

About the cobas® Liat® System

Utilizing PCR technology, the cobas® Liat® System fully automates the testing process, simplifies workflow and enables healthcare professionals to perform molecular testing in a variety of settings with speed, reliability and minimal training. Definitive results are generated in 20 minutes or less to aid a treatment decision. In addition to the existing tests for influenza A/B, strep A and influenza A/B & RSV, assays for other infectious diseases are in development.

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Hendra Virus Australia Breakthrough: Rapid Diagnostic Test Delivers Results in 10 Minutes

Horse owners can now breathe easy. A Queensland researcher is being hailed after a major breakthrough involving the deadly Hendra virus. University of Sunshine Coast researcher Joanna Kristoffersen has developed a rapid diagnostic test for the Hendra virus that can reportedly deliver results in 10 minutes, rather than up to 36 hours.

The test will eliminate the anxious wait for horse owners. To test for the Hendra virus, vets have to currently visit the property and send a sample to Brisbane. This results in unnecessary suffering for animals, delays in treatment and stress for owners. However, the new test works like a pregnancy test and delivers results onsite within 10 minutes.

Kristoffersen added that this rapid diagnostic test enables Hendra outbreaks to “be identified, contained and managed much more efficiently than current methods.” The new process will also be cheaper as there is no need for samples to be transported. The researchers are now looking to commercialise the product with Queensland Health and Biosecurity Queensland.

Kristoffersen, due to her research, is now among 10 finalists of the 2016 Fresh Science competition. It is a national program that highlights the work of early-career researchers.

“The test, if we can acquire further funding, has the potential to be performed on-site on a strip-read format called a lateral flow device. This test is specific, it's sensitive and we can detect nucleic acids rather than other snap tests that use an antibody antigen mechanism. We are working on commercialising it, and hopefully within one to two years we might be able to get this product out. It looks similar to an at-home pregnancy test,” Kristoffersen told the ABC.

Dr. Frank Condon, Atherton Tablelands vet and former president of the Equine Veterinarians Association, welcomed the test concept stating “It's very difficult from north Queensland to get samples down to Biosecurity Queensland to have them tested.” He added that the difficulty currently is distance and the wait time for the results. Hence, he said a fast testing method would be “fantastic.”

The Hendra virus is naturally-occurring in flying fox populations. It was discovered in 1994. The virus is passed onto horses via foetal fluids or faeces and also bat’s urine. Humans catch the deadly virus from horses.

As per Brisbane Times, the Hendra virus has killed more than 70 horses across NSW and Queensland and four out of seven people affected. Last month, a year-long trial for a human vaccine wound up. None of the 40 participants suffered any ill-effect.

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Spartan Bioscience Announces First Applications for World's Smallest DNA-Testing Device

Spartan Bioscience launched the world's smallest commercial molecular diagnostic device, the Spartan Cube, and announced its first applications. About the size of a coffee cup, or four inches cubed, the Cube enables unprecedented portability and convenience, enabling new application in fields such as infectious disease, pharmacogenetics, and food and water safety testing.

The Spartan Cube is a PCR-based platform that fully integrates DNA collection, extraction, and analysis, with an intuitive interface that is easy to operate. In addition, the Cube goes from sample to result in 30 minutes, a fraction of the time compared to lab-based testing.

Spartan announced three assays: Strep A, Apolipoprotein E (APOE), and Legionella.

Strep A

Pharyngitis or sore throat accounts for 40 million doctor visits annually in the United States. The leading cause is Streptococcus pyogenes bacteria (Group A β-hemolytic Streptococcus, Strep A).(1) For too long, doctors and patients have had to accept fast but inaccurate immunoassay Strep tests. The Cube enables rapid and accurate PCR-based Strep testing that is portable enough for a doctor's office or walk-in clinic. Spartan plans to submit a CLIA waiver application to the FDA for this test.

Apolipoprotein E (APOE)

Alzheimer's disease affects more than five million patients in the United States.(2) One-in-four people carry APOE genetic mutations that increase the risk of developing Alzheimer's.(3) These genetic carriers can be ideal candidates to enroll in clinical trials or research studies. The Cube is the fastest way to identify these potential patients based on their genetics. For example, patients can be tested for clinical trials in doctors' offices, walk-in clinics, or even nursing homes.

Legionella

Legionella is a group of bacteria that can colonize water systems such as cooling towers and Heating, Ventilation and Air Conditioning (HVAC) systems. Contaminated systems can cause serious respiratory illnesses, such as Legionnaires' disease. For example, in 2015, 12 people died in New York from a Legionella outbreak that was traced back to infected cooling towers.(4) The Cube is the first portable DNA-based Legionella testing device that is suitable for professional use in facilities management. For the first time, building managers can bring rapid and accurate Legionella testing on-site.

Paul Lem, M.D., CEO of Spartan Bioscience, says the Spartan Cube is bringing the power of rapid DNA testing to everyone.

"Just like mainframe computers gave way to smartphones, DNA-testing systems in central labs will give way to portable, on-demand DNA analyzers," says Dr. Lem. "And in the same way a smartphone allows you to run multiple apps at your fingertips, the Cube enables all kinds of molecular diagnostic tests whenever and wherever you want."

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New AOAC-RI PTM Certification for STEC Detection Workflow Provides Beef Producers with a Rapid but Simple Solution to Screen for STEC

Beef producers can simultaneously and accurately screen for Escherichia coli O157:H7 and the Big Six Shiga toxigenic E. coli (STEC) in 375g raw beef samples, enabling rapid product release.

Thermo Fisher Scientific, a market leader in culture media, microbiology, molecular and mass spectrometry systems, has been awarded AOAC-RI Performance Tested MethodsSM certification for its Applied Biosystems RapidFinder STEC Detection Workflow. Validated for use on the Applied Biosystems 7500 Fast System, the workflow is a two-stage real-time PCR method, designed to screen for and confirm E. coli O157:H7 and the Big 6 serogroups of non-O157 Shiga toxin-producing E. coli, defined by the USDA Food Safety and Inspection Service (FSIS) as adulterants in the American beef industry (serogroups O26, O45, O103, O111, O121 & O145).

“For beef producers, rapid and accurate results when screening products for STEC and other pathogens can bring substantial economic benefits. In addition, unnecessary product diversions and production shutdowns can be avoided, and risk to brand and reputation is minimized,” said Tim Carmack, group product director food safety, microbiology, Thermo Fisher Scientific. “While reference methods are accurate and sensitive, they take a minimum of two days to clear negative samples, and require a number of handling steps. Where alternative methods often require complex sample preparation steps or specialized enrichment media to achieve faster time to results, the RapidFinder STEC Detection Workflow screening test results are available in as few as 12 hours with a simplified workflow.”

The RapidFinder STEC Detection Workflow enables:

• Confidence in results — optimized workflow, co-developed with USDA-ARS, showed equivalent performance to the USDA-MLG reference method in AOAC-RI validation studies
• Simplified workflow — Semi-automated sample preparation option and simultaneous detection of E. coli O157:H7 and the Big 6 non-O157:H7 STEC in 375g raw ground beef and beef trim samples
• Rapid product release — same-day clearance of STEC-negative samples in as few as 12 hours and confirmation of presumptive positives with just one additional 40 minute PCR test
• Minimized costs, space requirements and handling — single enrichment step in non-proprietary enrichment broth

In addition to the RapidFinder STEC Detection Workflow, Thermo Fisher Scientific provides real-time PCR-based workflow solutions and other methods to test for a broad range of food safety and quality indicators including foodborne viruses, meat species identification and GMO markers, as well as an expanding range of custom developed assays. The Applied Biosystems 7500 Fast Real-Time PCR System provides expansive molecular capability and streamlined testing processes which may reduce overall costs.

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Chembio's DPP® Zika IgM/IgG Assay Obtains CE Mark for Rapid Point-of-Care Detection of Zika Virus

Chembio Diagnostics, Inc., a leader in point-of-care (POC) diagnostic tests for infectious diseases, today announced that it has obtained a CE mark for its DPP® Zika IgM/IgG Assay. The Chembio DPP® Zika IgM/IgG System, which includes an assay utilizing the patented DPP® technology, as well as a digital reader, the DPP® Micro Reader, are now cleared for commercialization and for sale in 17 European countries, including the United Kingdom, Germany, and France, as well as a majority of the Caribbean nations, not including Puerto Rico.

Chembio’s DPP® Zika IgM/IgG Assay detects antibodies from a 10uL fingerstick sample and provides quantitative results in 20 minutes, using the Company’s patented Dual Path Platform (DPP®) technology. The DPP® Zika IgM/IgG Assay is the first POC Zika test to obtain CE mark, and the Company expects to launch sales of the product in the eligible European and Caribbean nations during the second half on 2016.

Zika virus is a mosquito-borne virus that was first identified in Uganda in 1947. It is believed that the virus is transmitted to humans through the bite of an infected mosquito from the Aedes genus, mainly Aedes aegypti, the same mosquito that transmits dengue, chikungunya and yellow fever. On January 22, 2016, the Centers for Disease Control and Prevention (CDC) activated its Emergency Operations Center (EOC) to respond to outbreaks of Zika occurring in the Americas and increased reports of microcephaly and Guillain-Barré syndrome in areas affected by Zika. On February 1, 2016, the World Health Organization (WHO) declared a Public Health Emergency of International Concern (PHEIC) because of clusters of microcephaly and other neurological disorders in some areas affected by Zika. On February 8, 2016, CDC elevated its EOC activation to a Level 1, the highest level. Since 2015, Zika outbreaks have been recorded in more than 60 countries and territories, with symptoms similar to other arbovirus infections such as dengue, and include fever, skin rashes, conjunctivitis, muscle and joint pain, malaise, and headache.

John Sperzel, Chembio's Chief Executive Officer, commented, “We are pleased to report our obtaining of the CE mark, and we look forward to initiating sales of our DPP® Zika IgM/IgG Assay and DPP® Micro Reader, which we anticipate in both the eligible European and Caribbean nations during the second half of 2016. We are hopeful that our DPP® Zika IgM/IgG Assay and DPP® Micro Reader become valuable tools to address global health emergencies posed by emerging fever diseases such as Zika virus. The DPP® Zika IgM/IgG Assay has been on an accelerated product development schedule, and our early success is in large measure the result of initial funding from the Paul G. Allen Family Foundation, a versatile DPP® technology platform, Chembio’s scientific expertise, a global network of collaborations which enabled access to clinical specimens, and the positive interaction with regulatory agencies.”

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Researchers Use NIFA Grant to Develop Rapid Food Safety Test

Keeping the food on America’s tables safe to eat is a major priority at USDA, where we are constantly working to find innovative ways to stay a step ahead of bacteria and other dangerous contaminants that can cause illness. Thanks in part to a grant from USDA’s National Institute of Food and Agriculture (NIFA), a research team led by Dr. Bryan Chin, director of the Auburn University Detection and Food Safety Center, has developed a cheap, portable and easy-to-use new screening tool to test fresh fruits and vegetables for the presence of bacteria that can cause foodborne illnesses.

Currently available screening methods for produce can be costly in terms of time, equipment, and expertise. The multidisciplinary research team of engineers, microbiologists, and genomicists based at Auburn University and the University of Georgia wanted to create a new method that could be used more broadly.

The team has developed biosensors that are placed directly upon the fresh fruits or vegetables being analyzed. The eyelash-size biosensors are coated with antibodies and phages (viruses that target specific bacteria) and vibrate when placed within an oscillating magnetic field. If targeted bacteria are present, they bind to the antibodies and phages and change the vibration frequency of the biosensor. These frequency changes help inspectors determine the type and amount of bacteria on a given fruit or vegetable.

“The technology gives us a revolutionary new capability to directly detect food pathogens,” Chin said. It is fast and has both high specificity and sensitivity. In less than 12 minutes, the sensors can detect as few as five hundred Salmonella cells amid a sea of a million bacterial cells. The measurement system costs $750, with each of the disposable biosensors costing less than 1/1000 of a cent.

The biosensors are still in the research and development stages. Moving forward, Chin has his sights set on developing a technology that is even faster and is capable of screening an entire bulk shipment of product, removing sub-sampling entirely.

USDA consistently conducts and funds food safety research to generate real-world results for both government and the private sector. In 2014 alone, USDA’s NIFA provided more than $112 million for food safety research, education and extension projects to help build a modern public health system.

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Crystal Diagnostics Awarded AOAC-PTM Accreditation for the Rapid Screening of Listeria on Environmental Surfaces

Crystal Diagnostics Xpress System, a rapid and sensitive detection platform, announced today that it has received AOAC-PTM Certifications for Listeria for rapid screening of low concentrations of Listeria monocytogenes on environmental surfaces such as stainless steel, plastic, and ceramic tile.
The CDx Xpress System combines proprietary liquid crystal technology with antibody-coated paramagnetic microspheres to selectively capture and detect food-borne pathogens faster than other commercial systems.

CDx previously announced that it had been accredited by AOAC for detection of E. coli O157, Salmonella, and the “Big 6” STECs. According to CDx President and CEO Jim Bruce, “CDx is now ahead of schedule in expanding our portfolio of target pathogens and food types with our rapid and accurate liquid crystal biosensors. We will continue to add additional food-borne pathogens and food types in our offering of fast and reliable AOAC accredited tests.”

Dr. Matthew Taylor, Associate Professor of Food Microbiology, Texas A&M University, said that “Crystal Diagnostics is making significant inroads with the additional pathogen targets being added to its product line. My laboratory has recently instituted a funded study testing of beef samples utilizing the liquid crystal biosensors…results have been impressive.”

The Company has national distribution through Hardy Diagnostics and sales agreements with distributors in Central America and Australia.

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Alere™ HIV Combo Test Receives WHO Prequalification

Alere, a global leader in rapid diagnostics, announced that its Alere™ HIV Combo, a rapid point-of-care fourth-generation test that detects both HIV-1/2 antibodies and the HIV-1 p24 antigen, has been awarded World Health Organization (WHO) prequalification, making it available for public sector procurement in resource-limited countries.

Conventional second- and third-generation HIV rapid tests can only detect antibodies against HIV which may not appear until three weeks after infection.1 Alere HIV Combo detects not only these antibodies but can also detect free HIV-1 p24 antigen which can appear up to 7.7 days earlier.1 For global HIV programmes this means the potential to increase case finding particularly in key high risk populations that have been disproportionally affected by HIV.

"WHO's prequalification of the Alere HIV Combo reflects our commitment to making high-quality point-of-care HIV diagnostics available in areas with the greatest burden of HIV infection," said Avi Pelossof, Alere Global President of Infectious Disease. "The first step in eradicating AIDS is identifying as many individuals as possible infected with HIV and linking them to care. Now, even more healthcare workers will be able to accomplish this with a new 4th generation HIV point-of-care test available today."

"We can't meet UNAIDS' 90-90-90 target unless we achieve the first goal of ensuring that people with HIV know their status, and this requires helping healthcare workers in developing countries make every testing opportunity count," said Collins Odhiambo, Ph.D., who evaluated the Alere HIV Combo at the Kenya Medical Research Institute (KEMRI). "The Alere HIV Combo brings point-of-care diagnosis directly to people at greatest risk for infection – including those in remote areas – and makes screenings as impactful as possible by enabling healthcare workers to identify highly infectious individuals, and link them to treatment."

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