ABBOTT PARK, Ill., March 27, 2020
/PRNewswire/ -- Abbott (NYSE: ABT) announced today that the
U.S. Food and Drug Administration (FDA) has issued Emergency Use
Authorization (EUA) for the fastest available molecular
point-of-care test for the detection of novel coronavirus
(COVID-19), delivering positive results in as little as five
minutes and negative results in 13 minutes. The test will run on
the company's ID NOW™ platform, providing rapid results
in a wide range of healthcare settings such as physicians' offices,
urgent care clinics and hospital emergency departments.
The ID NOW platform is small, lightweight (6.6 pounds) and
portable (the size of a small toaster), and uses molecular
technology, which is valued by clinicians and the scientific
community for its high degree of accuracy. ID NOW is already the
most widely available molecular point-of-care testing platform in
the U.S. today.
"The COVID-19 pandemic will be fought on multiple fronts, and a
portable molecular test that offers results in minutes adds to the
broad range of diagnostic solutions needed to combat this virus,"
said Robert B. Ford, president and
chief operating officer, Abbott. "With rapid testing on ID NOW,
healthcare providers can perform molecular point-of-care testing
outside the traditional four walls of a hospital in outbreak
hotspots."
Abbott will be making ID NOW COVID-19 tests available next week
to healthcare providers in urgent care settings in the U.S., where
the majority of ID NOW instruments are in use today. The company is
working with the Administration to deploy tests to areas where they
can have the greatest impact.
The arrival of the Abbott ID NOW COVID-19 test comes a week
after the company launched its Abbott m2000™
RealTime SARS-CoV-2 EUA test, which runs on the
m2000™ RealTime System located in hospital
and reference labs around the world. Between the two platforms,
Abbott expects to produce about 5 million tests per month.
About the ID NOW™ Molecular Platform
As the world leader in point-of-care diagnostics, Abbott is adding
its expertise and scale to help fight the COVID-19 global pandemic.
First introduced in 2014, ID NOW is the leading molecular
point-of-care platform for Influenza A & B, Strep A and RSV
testing in the U.S.
ID NOW is a rapid, instrument-based, isothermal system for the
qualitative detection of infectious diseases. Its unique isothermal
nucleic acid amplification technology provides molecular results in
just minutes, allowing clinicians to make evidence-based clinical
decisions during a patient visit.
About Abbott
Abbott is a global healthcare leader
that helps people live more fully at all stages of life. Our
portfolio of life-changing technologies spans the spectrum of
healthcare, with leading businesses and products in diagnostics,
medical devices, nutritionals and branded generic medicines. Our
107,000 colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn at
www.linkedin.com/company/abbott-/, on Facebook
at www.facebook.com/Abbott and on Twitter @AbbottNews and
@AbbottGlobal.
The ID NOW COVID-19 EUA has not been FDA cleared or approved.
It has been authorized by the FDA under an emergency use
authorization for use by authorized laboratories and patient care
settings. The test has been authorized only for the detection of
nucleic acid from SARS-CoV-2, not for any other viruses or
pathogens, and is only authorized for the duration of the
declaration that circumstances exist justifying the authorization
of emergency use of in vitro diagnostic tests for detection and/or
diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C.
§ 360bbb-3(b)(1), unless the authorization is terminated or revoked
sooner.
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SOURCE Abbott