Test received FDA EUA; commercialization begins
NEW HAVEN, CT, (July 30th, 2020) - Specialty diagnostics company Precipio, Inc. (NASDAQ: PRPO), is announcing its COVID-19 strategy, and its intent to contribute to the battle against the ensuing worldwide pandemic. Today, the company announced it entered into an agreement with ADS Biotec, a US company based in Omaha, Nebraska, to distribute its FDA-authorized COVID-19 serology antibody tests that recently received EUA (Emergency Use Authorization). Distribution of the product will take place in the US 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.
Virus vs. Antibody test
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.
Demand and Go-to-Market Strategy
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, we 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”.
Precipio has built a platform designed to eradicate the problem of misdiagnosis by harnessing the intellect, expertise and technology developed within academic institutions and delivering quality diagnostic information to physicians and their patients worldwide. Through its collaborations with world-class academic institutions specializing in cancer research, diagnostics and treatment such as the Yale School of Medicine and Harvard’s Dana-Farber Cancer Institute, Precipio offers a new standard of diagnostic accuracy enabling the highest level of patient care. For more information, please visit www.precipiodx.com.
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including, among others, statements related to the expected or potential impact of the novel coronavirus (COVID-19) pandemic, and the related responses of the government, consumers, and the company, on our business, financial condition and results of operations, and any such forward-looking statements, whether concerning the COVID-19 pandemic or otherwise, involve risks, assumptions and uncertainties. Except for historical information, statements about future volumes, sales, growth, costs, cost savings, margins, earnings, earnings per share, diluted earnings per share, cash flows, plans, objectives, expectations, growth or profitability are forward-looking statements based on management’s estimates, beliefs, assumptions and projections. Words such as “could,” “may,” “expects,” “anticipates,” “will,” “targets,” “goals,” “projects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “predicts,” and variations on such words, and similar expressions that reflect our current views with respect to future events and operational, economic and financial performance, are intended to identify such forward-looking statements. These forward-looking statements are only predictions, subject to risks and uncertainties, and actual results could differ materially from those discussed. Important factors that could affect performance and cause results to differ materially from management’s expectations, or could affect the company’s ability to achieve its strategic goals, include the uncertainties relating to the impact of COVID-19 on the company’s business, operations and employees and the other factors that are described in the sections entitled “Risk Factors” and “Management’s Discussion and Analysis” in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as updated from time to time in the company’s Securities and Exchange Commission filings.
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