Specialty cancer diagnostics company Precipio,
Inc. (NASDAQ: PRPO) announces that following receipt of an
Emergency Use Authorization from the FDA by Nirmidas Biotech, Inc.,
the developer and manufacturer of the COVID-19 antibody test,
Precipio has begun to roll out these tests to the market.
After signing a sales
and distribution agreement with Nirmidas earlier this week,
Precipio has started with its installed oncology customer base, and
will continue to expand into the market via additional sales
channels. The test, produced by Nirmidas, a biotech company based
in Palo Alto, CA is the first US-based product to receive EUA for
point-of-care for its rapid COVID-19 antibody test.
As the nationwide
rollout of the vaccine continues, the value of rapid antibody
testing increases dramatically. First, to those who are
deliberating whether to take the vaccine or not, the results of an
antibody testing offers another important data point in making that
decision. Individuals who have been infected with the virus
(whether they display symptoms, or are asymptomatic), and
subsequently develop antibodies that are detected by the COVID-19
antibody test, can use that result as another decision-making
factor as they consider the vaccine. The test offered by Precipio
employs the SARS-CoV-2 spike protein’s RBD antigen for detection,
which is the specific binding target of neutralization antibodies
resulting from vaccines or prior COVID-19 infection.
Additionally, given
that the vaccine is designed to create a response that will cause
the body to develop antibodies, the ability to test for the
presence of these antibodies post-vaccination will provide an
important tool for individuals and healthcare providers to assess
the efficacy of the vaccine.
Precipio encourages
all individuals to consult with their physician as to their
decisions regarding testing, vaccination, and other decisions
regarding their healthcare.
“We are excited to
partner with Precipio to make our tests rapidly and widely deployed
in the US for point-of-care testing,” said Nirmidas CEO Dr. Meijie
Tang. “We also look forward to developing a test that could be used
in every household.“
“We are delighted to
see the fruits of our work culminate in the ability to now bring
this important test to the market, and contribute to the battle
against this pandemic,” said Ilan Danieli, Precipio’s CEO. “The FDA
continues to demonstrate their willingness to expand the reach and
usability of these tests, and we hope to soon see progress on the
at-home testing front as well.”
About Nirmidas
Based in Silicon Valley, Nirmidas combines
chemistry, biology, bio-engineering, and optical imaging, with a
focus on red to near-infrared fluorescence enhancement
technologies. Commercialized applications include diagnostics and
imaging for early disease diagnosis, prognosis monitoring,
population screening, and therapeutics. Nirmidas was originally a
spin-off from Stanford University and is a member of the StarX Med
COVID-19 Task Force. Please visit www.nirmidas.com.
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, Harvard’s
Dana-Farber Cancer Institute, and the University of Pennsylvania,
Precipio offers a new standard of diagnostic accuracy enabling the
highest level of patient care. For more information, please visit
www.precipiodx.com.
Please follow us on Twitter @PrecipioDx and on
Facebook.
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
Precipio (NASDAQ:PRPO)
Historical Stock Chart
From Aug 2024 to Sep 2024
Precipio (NASDAQ:PRPO)
Historical Stock Chart
From Sep 2023 to Sep 2024