On Jul. 30, 2020, Precipio announced it had entered into an agreement with ADS Biotec, based in Omaha, Nebraska, to distribute its U.S. Food and Drug Administration (FDA)-authorized COVID-19 serology antibody tests that recently received EUA (Emergency Use Authorization). Distribution of the product was planned in the U.S. as well as in other markets worldwide.

Precipio will begin rolling out these antibody tests initially as a CLIA test run in its laboratory (expected launch August); then further roll out (pending further FDA authorization) to physician offices as a POC (point-of-care) test; and finally, through distribution via various retail channels for at-home, DTC (direct-to-consumer) use.

While both the active virus and antibody tests are important elements of controlling the pandemic, antibody testing is key to enabling society to return to full functionality. The antibody test for IgM and IgG detects the body’s immune response to the infection caused by the virus. As stated by the FDA, antibody tests could play a role in the fight against COVID-19 by helping healthcare professionals identify individuals who may have developed an immune response to the SARS-CoV-2 virus. This is a key to returning our children to schools, adults to work, opening up the economy and resuming life as we knew it prior to the pandemic.

There are several mechanisms to conduct the COVID-19 antibody tests, ranging from sophisticated laboratory equipment, to small, individualized tests (much like a pregnancy test). Such is the lateral flow antibody test cassette, a simple, single-use device that doesn’t require a laboratory, and shows potential to ultimately be self-administered by individuals in an at-home environment.

A recent Harvard University study indicated the need from 5 to 20 Million tests per day in the US. Current laboratory testing capacity in the US is estimated at only several hundred thousand per day.

The FDA was currently approving EUA usage only for antibody testing to be conducted in designated laboratories. However, we believe that the path to meeting market demand will be approval for POC, followed by eventual clearance for at-home usage. The FDA has already released various guidelines as to the pathway to obtain approval for POC use.

Over the next few months, the Precipio COVID-19 team will focus on the immediate launch of the test in our CLIA facility, offering the test to Precipio’s customer base. In addition, the company will be further developing a POC and DTC strategy for the US and other global markets.