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.

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.

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.

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.

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.

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.

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.