8 October 2020 - - US-based diagnostics provider 20/20 BioResponse, a business unit of 20/20 GeneSystems, Inc, is accepting orders for the Assure COVID-19 IgG/IgM Rapid Test kits, the company said.

These kits were the first to receive an emergency use authorization from the FDA for point-of-care 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.

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 specialises 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.

20/20 GeneSystems, Inc is a Rockville, MD based company focused on diagnostics and detection products.

In addition to the company's blood tests for early cancer detection, 20/20 has also commercialised its patented BioCheck detection kit to help fire departments and other emergency response organisations screen suspicious powders.