Thursday, October 15, 2020

20/20 Launching First COVID-19 Rapid Antibody Test Authorized by FDA for Point-of-Care Use

20/20 BioResponse, a business unit of 20/20 GeneSystems, Inc., announced today that it is now accepting orders for the Assure COVID-19 IgG/IgM Rapid Test kits. These kits were the first to receive an emergency use authorization (EUA) from the FDA for point-of-care (POC) use with fingerstick blood samples on September 23. According to the FDA announcement “this authorization means that fingerstick blood samples can now be tested in POC settings like doctor’s offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab for testing.” “Authorizing POC serology tests will enable more timely and convenient results for individuals who want to understand if they have previously been infected with the virus that causes COVID-19,” said FDA Commissioner Stephen M. Hahn, M.D.

The company is now accepting orders from pharmacies, urgent care centers, and doctor’s offices, especially those servicing first responders.

The test kits are rapid chromatographic immunoassays (configured like a home pregnancy test) to detect IgM and IgG antibodies to COVID-19 SARS-CoV-2 in blood, which is the cause of COVID-19. IgM antibody generally begins to rise within 1 week of initial infection and IgG typically appears about 14 days after infection.

“As vaccines begin to enter the market over the coming months, we believe there will be increasing demand by individuals and their healthcare providers for antibody tests,” said Michael Lebowitz, Ph.D., 20/20’s Chief Scientific Officer. “The presence of serum antibodies against an infectious agent may be an indicator of immunity against said agent. Until such time as the durability of the immune response is established, it will be important for both those who have had a prior infection as well as those who have received a vaccine to be monitored on a regular basis for the presence of antibodies. Such information can be used to suggest that an individual may benefit from a boost with the vaccine”.

20/20 also plans to conduct studies to validate the use of an at-home fingerstick blood collection device together with a quantitative antibody test awaiting an EUA from the FDA. Quantitative tests permit individuals to monitor changes in their antibody levels over time and may help assess susceptibility to future infections. The company, which specializes in developing machine learning algorithms associated with laboratory tests, will seek to build algorithms to help predict and quantify the strength and durability of immune response.

About 20/20 GeneSystems: 

20/20 GeneSystems, Inc. is a Rockville, MD based company focused on innovative diagnostics and detection products. In addition to the company’s blood tests for early cancer detection, 20/20 has also commercialized its patented BioCheck® detection kit to help fire departments and other emergency response organizations screen suspicious powders.