ABBOTT PARK, Ill., Aug. 26, 2020
/PRNewswire/ -- Abbott (NYSE: ABT) announced today that the
U.S. Food and Drug Administration (FDA) has issued Emergency Use
Authorization (EUA) for its BinaxNOW™ COVID-19 Ag Card rapid test for detection of COVID-19
infection. Abbott will sell this test for $5. It is highly portable (about the size of a
credit card), affordable and provides results in 15 minutes.
BinaxNOW uses proven Abbott lateral flow technology, making it a
reliable and familiar format for frequent mass testing through
their healthcare provider. With no equipment required, the device
will be an important tool to manage risk by quickly identifying
infectious people so they don't spread the disease to others.
Abbott will also launch a complementary mobile app for iPhone
and Android devices named NAVICA™. This first-of-its-kind app,
available at no charge, will allow people who test negative to
display a temporary digital health pass that is renewed each time a
person is tested through their healthcare provider together with
the date of the test result. Organizations will be able to view and
verify the information on a mobile device to facilitate entry into
facilities along with hand-washing, social distancing, enhanced
cleaning and mask-wearing.
"We intentionally designed the BinaxNOW test and NAVICA app so
we could offer a comprehensive testing solution to help Americans
feel more confident about their health and lives," said
Robert B. Ford, president and chief
executive officer, Abbott. "BinaxNOW and the NAVICA app give us an
affordable, easy-to-use, scalable test, and a complementary digital
health tool to help us have a bit more normalcy in our daily
lives."
In data submitted to the FDA from a clinical study conducted by
Abbott with several leading U.S. research universities, the
BinaxNOW COVID-19 Ag Card
demonstrated sensitivity of 97.1% (positive percent agreement) and
specificity of 98.5% (negative percent agreement) in patients
suspected of COVID-19 by their healthcare provider within the first
seven days of symptom onset.
"The massive scale of this test and app will allow tens of
millions of people to have access to rapid and reliable testing,"
said Joseph Petrosino, Ph.D.,
professor and chairman, Molecular Virology and Microbiology,
Baylor College of Medicine, whose labs
have been leading efforts to provide COVID-19 testing for the
college and Harris County. "With lab-based tests, you get excellent
sensitivity but might have to wait days or longer to get the
results. With a rapid antigen test, you get a result right away,
getting infectious people off the streets and into quarantine so
they don't spread the virus."
Under FDA EUA, the BinaxNOW COVID-19 Ag
Card is for use by healthcare professionals and can be used
in point-of-care settings that are qualified to have the test
performed and are operating under a CLIA (Clinical Laboratory
Improvement Amendments) Certificate of Waiver, Certificate of
Compliance, or Certificate of Accreditation. Within these settings,
the test can be performed by doctors, nurses, school nurses,
medical assistants and technicians, pharmacists, employer
occupational health specialists, and more with minimal training and
a patient prescription.
"Our nation's frontline healthcare workers and clinical
laboratory personnel have been under siege since the onset of this
pandemic," said Charles Chiu, M.D.,
Ph.D., professor of Laboratory Medicine at University of California, San Francisco. "The
availability of rapid testing for COVID-19 will help support
overburdened laboratories, accelerate turnaround times and greatly
expand access to people who need it."
Currently, AdvaMed (The Advanced Medical Technology Association)
estimates that test manufacturers are shipping about 1 million
tests per day. Abbott will ship tens of millions of tests in
September, ramping to 50 million tests a month at the beginning of
October. The company has invested hundreds of millions of dollars
since April in two new U.S. facilities to manufacture BinaxNOW at
massive scale.
The BinaxNOW COVID-19 Ag Card can
be used as a first line of defense to identify people who are
currently infected and who should isolate themselves to help
prevent the spread of the disease. It is intended for the
qualitative detection of nucleocapsid protein antigen from
SARS-CoV-2 in nasal swabs from individuals suspected of COVID-19 by
their healthcare provider within the first seven days of symptom
onset.
As a near-person rapid antigen test, BinaxNOW was engineered for
point-of-care settings, near-patient, and not for reference labs.
Patient samples should be tested immediately and should not be
diluted in viral transport media.
NAVICA mobile app will help facilitate return to daily
activities
Abbott is also offering a mobile app at no charge that will allow
people to display their results obtained through a healthcare
provider when entering facilities requiring proof of testing. The
NAVICA app is optional and an easy-to-use tool that allows people
to store, access and display their results with organizations that
accept the results so people can move about with greater
confidence. The app is supported by Apple and Android digital
wallets and will be available from public app stores in the
U.S.
"While BinaxNOW is the hardware that makes knowing your COVID-19
status possible, the NAVICA app is the digital network that allows
people to share that information with those who need to know," said
Ford. "We're taking our know-how from our digitally-connected
medical devices and applying it to our diagnostics at a time when
people expect their health information to be digital and readily
accessible."
If test results are negative, the app will display a digital
health pass via a QR code, similar to an airline boarding pass. If
test results are positive, people receive a message to quarantine
and talk to their doctor. As they're required to do for all
COVID-19 tests, healthcare providers in all settings will be
required to report positive results to the CDC and other public
health authorities, regardless of whether they use the app. The
digital health pass is stored in the app temporarily and expires
after the time period specified by organizations that accept the
app.
The app's user interface is supported by a back-end digital
infrastructure that is cloud-based, scalable and secure. It's been
designed to support a very large number of users and enable access
from anywhere. The app is not for contact tracing and only collects
a person's first and last name, email address, phone number, zip
code, date of birth and test results.
About the BinaxNOW COVID-19 Ag Card
Test
The BinaxNOW COVID-19 Ag Card is an
assay for the qualitative detection of specific antigens to
COVID-19 in the human nasal cavity. A simple nasal swab is used to
collect specimens from people suspected of having an active
infection. No equipment is required to process samples or read test
results. In addition, minimal chemical reagents are required, which
lessens exposure to biohazardous materials and improves safety for
those administering the test.
The BinaxNOW COVID-19 Ag Card is
the sixth test that Abbott is launching in the U.S. to help fight
the coronavirus pandemic. Abbott's tests are performed on its
high-volume m2000™ and Alinity® m molecular laboratory
systems; its ID NOW™ rapid molecular point-of-care platform;
antibody tests for its high-throughput ARCHITECT® i1000SR and
i2000SR and Alinity™ i laboratory instruments.
Abbott has provided more than 27 million COVID-19 tests in the
U.S. to date, including 14 million detection tests and 13 million
antibody tests.
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 BinaxNOW™ COVID-19 Ag Test Card 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 proteins 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