Thursday, Nashville based Webb Diagnostics thanked Congressman Robert Aderholt (R-Haleyville) for his assistance in receiving emergency FDA approval for their innovative rapid antibody test to not only detect active COVID-19 infections; but also past exposure to the virus, possibly indicating immunity to the virus.
This type of widespread, rapid testing is an important element in Congressman Aderholt’s recommendations to Alabama Governor Kay Ivey about how and when to begin reopening the Alabama economy.
“The American economy cannot stay closed forever and plans are being made now for a phased approach for getting industry back up and running, businesses opened and people back to work,” Rep. Aderholt said in a statement. “But an important part of getting us back to normal is widespread, fast, reliable antibody testing.”
“To that end, I’m excited that Webb Diagnostic Technologies has completed its own validation process and is moving forward with the process to receive Emergency Use Authorization (EUA) from the FDA,” Aderholt continued. “Within 60 seconds, blood from a small finger prick can detect, not only an active infection, but if the person has already been exposed to COVID-19 and is now likely immune.”
Webb Diagnostics Technologies (WebbDX) announced that in response to the White House Coronavirus Task Force request for a “finger prick-type assay” to detect SARS-CoV-2 antibodies, the company 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 strain of the coronavirus that causes COVID-19.
The company said in their statement that, 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. Webb claims that 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.
Dr. William Schaffner, M.D., is a 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.
“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 Dr. Schaffner. “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 and scalable platform that has received regulatory approval in many countries, including from the FDA. 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.
Many serology tests utilize lateral flow technology that requires a specialized laboratory environment and can take up to 25 minutes to yield results. The WebbDX test is 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).
Dr. Kevin Jones, PhD is the Chief Technology Officer at WebbDX.
“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 Dr. Kevin Jones. “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.”
MedMira has submitted FDA (Food and Drug Administration) notification under the name REVEALCOVID-19TM.
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 has begun. To date, no serological test has received emergency use authorization from the FDA for use in a non-traditional setting.
Rep. Aderholt is a member of the powerful House Committee on Appropriations, which has jurisdiction over funding the operation of the federal government.
“I was proud to help this company, which has assets in Alabama and Tennessee, make connections within Alabama to ensure that the scientists at Webb had everything they needed to work on this antibody test,” Aderholt added. “I commend them for showing true American entrepreneurship in seeing a vital need and responding in record time.”
“Late last week, I was on a phone call with the FDA Commissioner Stephen Hahn and highlighted for him that the speed and accuracy of this test seem so promising,” Aderholt explained. “When I mentioned that the notification of the product would be submitted in the coming days, the commissioner agreed to be on the lookout for it.”
“It’s this type of testing that will allow us to reopen our economy in a safe manner and put an end to this pandemic,” Aderholt concluded.
The test will be manufactured in the United States.
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.
Webb Diagnostic Technologies is based in Nashville, Tennessee. According to their mission statement, Webb DX 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.
As of press time 987,322 Americans have been diagnosed with COVID-19. 55,415 have already died in the global pandemic; while 118,781 have recovered.
Congressman Robert B. Aderholt represents Alabama’s Fourth Congressional District. He is serving in his twelfth term in the U.S. House of Representatives.