NASHVILLE, Tenn., April 23, 2020 /PRNewswire/ -- In response to the White House Coronavirus Task Force request for a "finger prick-type assay" to detect SARS-CoV-2 antibodies, Webb Diagnostic Technologies (WebbDX) will begin marketing a Point-of-Care (POC) serology test in the U.S. that can instantly detect antibodies in whole blood, serum and plasma for SARS-CoV-2, the virus that causes COVID-19.
Unlike other serology tests, this high-sensitivity total antibody test is designed to detect all human immunoglobulins, including IgG, IgM and IgA, which may indicate previous or present exposure to SARS-CoV-2. This information is crucial in limiting the spread of the virus – even in the early stages of infection – and will pave the way for people to return to work and restart the U.S. economy.
"The utility of a test like this cannot be overstated. For hospitals and public health providers to be able to sort out who among their health care workers has the antibodies is a game changer," said William Schaffner, M.D., professor of Preventive Medicine and Health Policy in the Division of Infectious Diseases at Vanderbilt University School of Medicine and a member of the WebbDX Scientific Advisory Board. "Precautions and protections will still be required, of course, but the delivery of care becomes safer and more efficient – for patients and caregivers alike."
The test was developed and validated in North America using MedMira' s (TSXV: MIR) Rapid Vertical Flow (RVF) Technology®, a practical, scalable, FDA-approved platform that has received regulatory approval in many countries. RVF Technology® has been used reliably around the world for more than a decade to detect infectious diseases such as HIV, Hepatitis-B, Hepatitis-C and syphilis. The test will be manufactured in the United States. MedMira has submitted FDA notification under the name REVEALCOVID-19™.
Many serology tests utilize lateral flow technology that requires a specialized laboratory environment and can take up to 25 minutes to yield results. WebbDX will offer a standalone, disposable and portable total antibody blood test that fits in the palm of your hand and can detect antibodies against SARS-CoV-2 in approximately one minute (three minutes from blood draw until test completion).
"Dozens of new serological tests have been flooding the market but none yet check all the boxes in terms of accuracy, speed and ease of use outside a laboratory setting or without specialized equipment and personnel," said Kevin Jones, PhD, Chief Technology Officer of WebbDX. "We knew we could build a better test. Working with our partners in academic medicine and government, we're now able to bring to market a total antibody test that is not only fast and highly sensitive, but deployable in virtually any point of care."
Filing for FDA Emergency Use Authorization (EUA) for use of the test in both a moderately complex lab setting and at any Point of Care will begin immediately. To date, no serological test has received emergency use authorization from the FDA for use in a non-traditional setting.
"The American economy cannot stay closed forever and an important part of getting us back to normal is widespread, fast and reliable antibody testing," said Rep. Robert B. Aderholt (R-AL), a member of the House Committee on Appropriations, which has jurisdiction over funding the operation of the federal government. "I am encouraged that WebbDX has completed its own validation process of this promising test and commend the company for showing true American entrepreneurship in seeing a vital need and responding in record time."
The test can be easily and inexpensively mass produced to meet the country's urgent demand for a reliable antibody test that can be used in a variety of settings – both in and outside a traditional lab.
About Webb Diagnostic Technologies
Based in Nashville, Tennessee, Webb Diagnostic Technologies is dedicated to creating innovative diagnostic solutions that fill emerging needs. Leveraging the application of technologies from the fields of biotechnology, immunochemistry, biomedical engineering and clinical science with strategic partnerships with hospitals, universities and national laboratories, WebbDX develops and brings to market diagnostic solutions for emerging and hard-to-diagnose diseases and conditions. For more information, visit webbdx.com.
MEDIA CONTACT: Robin Embry, Lovell Communications, [email protected], 615-750-9033
SOURCE Webb Diagnostic Technologies