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”.
About Precipio
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.
Forward-Looking Statements
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.
The company’s forward-looking statements in this
press release are based on management’s current views, beliefs,
assumptions and expectations regarding future events and speak only
as of the date of this release. The company undertakes no
obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise, except as required by the federal securities
laws.
Inquiries:
investors@precipiodx.com
+1-203-787-7888 Ext. 523
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