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 indicates 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. We believe that the only way to deliver testing at the scale required to achieve proper testing capacity would be through at-home use.
The FDA is 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.
As the company continues to make progress on these initiatives, it will keep our shareholders updated, alongside the continued development of our core businesses.
“We are pleased to collaborate with Precipio as our trusted partner to broaden the market for our high quality and reliable COVID-19 antibody tests,” said Vijay Dube, CEO at ADS Biotec. “With production capacity of over 1M tests per day, we, along with Precipio, are well positioned to meet the increasing market demand for COVID-19 testing.”
“We are delighted to partner with ADS Biotec, using their high quality product to help expand much-needed testing, both in the US and worldwide,” said Ilan Danieli, Precipio’s CEO. “As a member of the healthcare community, this project represents a huge opportunity for Precipio to play a substantial role in the battle against the COVID-19 pandemic.”