ABBOTT PARK, Ill., April 19, 2021
/PRNewswire/ -- Abbott (NYSE: ABT) announced today it began
shipping its BinaxNOW™ COVID-19 Ag Self Test to retailers
across the country. Consumers can expect the test to be available
in the next few days online and in some stores. Broader nationwide
availability is expected in the next two weeks as tests work their
way through distribution channels.
The BinaxNOW Self Test initially will be available at CVS
Pharmacy, Walgreens and Walmart as part of Abbott's commitment to
get the country's most studied COVID-19 rapid test to as many
Americans as possible. The test, which can be purchased over the
counter without a prescription, will then roll out to other major
food, drug and mass merchandisers in the weeks ahead.
"Over the past year, Abbott has developed high-quality rapid
testing and invested in U.S. facilities to scale up manufacturing
so we could bring affordable testing to Americans on a mass scale,"
said Robert B. Ford, president and
chief executive officer, Abbott. "We're pleased to be working with
the country's leading retailers to provide broad access to this
affordable test so that it gets out into the communities that need
it most."
Abbott will manufacture tens of millions of BinaxNOW Self Tests
per month and can further scale capacity based on demand. Abbott
can also work with retailers to prioritize distribution to areas of
the country where the virus is surging as additional supply comes
online.
The BinaxNOW Self Test will be sold in 2-count packs for an MSRP
of $23.99, making it the most
affordable OTC COVID-19 rapid test available in the U.S. Abbott is
the only manufacturer in the U.S. that has Emergency Use
Authorization (EUA) for a COVID-19 self test that can provide tests
immediately at this scale.
"Let's not back down on testing, let's double down on it," said
Thomas Quinn, M.D., professor of
medicine and pathology at the Johns Hopkins
School of Medicine. "As long as COVID remains unpredictable,
there's an important role for the corner pharmacy and the central
lab to tackle this virus in tandem, which gives this country the
best chance to detect and screen for COVID-19."
The CDC advises that "a robust and responsive testing
infrastructure is essential to our success in stopping the spread
of SARS-CoV-2" and provides guidance on the important role both PCR
tests and rapid antigen tests play in detecting infections and
screening individuals. Abbott will continue bringing
accessible testing options and lead the U.S. in supplying COVID-19
tests for use in labs, at the point of care, and now over the
counter.
Proven testing technology now broadly available
On
March 31, Abbott announced that it
received FDA EUA for over-the-counter, non-prescription,
symptomatic and asymptomatic use of its BinaxNOW™ COVID-19
Ag Self Test for detection of
COVID-19 infection. This new indication allows individuals with or
without symptoms to have access to this test without a
prescription, bringing the country's most extensively studied and
widely used rapid antigen test to nearly everyone in the U.S. The
test will come in a two-count pack to meet serial (frequent)
testing requirements.
The BinaxNOW Self Test uses the same technology as the existing
BinaxNOW test that has been available since August 2020 but is now indicated by the FDA for
serial symptomatic and asymptomatic testing, meaning that people
should test themselves frequently. The test can be used on children
as young as two years old when samples are collected by an adult
and for all people aged 15 years or older.
Using the BinaxNOW Self Test will be simple, even for people who
have never tested themselves. People will only need to perform a
minimally invasive nasal swab (not the deep nasopharyngeal swab)
and all materials required to perform the test (swab, test card,
and reagent solution) will come in the box. With results in just 15
minutes, the BinaxNOW Self Test lets people who test positive
immediately isolate so that they do not infect others, rather than
waiting days for results from a lab or send-away at-home tests.
Abbott launched the BinaxNOW professional test nationwide in
August 2020 and scaled up production
at its new U.S. manufacturing facilities to produce 50 million
tests per month. The U.S. Department of Health and Human Services
(HHS) purchased the company's first 150 million tests, sending them
to K-12 schools, nursing homes, historically black colleges and
universities, and underserved communities, where they remain in use
today and serve as a powerful tool to help prevent the virus from
spreading.
Since its original authorization in August 2020, the BinaxNOW COVID-19 professional
use test has gone on to be used by workplaces, additional
universities and other organizations throughout the country.
BinaxNOW performance in the field
Today, BinaxNOW
demonstrates overall performance of 84.6% positive agreement
(sensitivity) and 98.5% negative agreement (specificity) in people
seven days or less post-symptom onset at all Ct counts. In our
studies, it further shows performance of 95.6% positive agreement
(sensitivity) in people seven days or less post-symptom onset with
Ct counts of 33 or below. Ct counts are the number of times a PCR
instrument must cycle through to amplify enough genetic material of
the SARS CoV-2 virus for it to be detectable. The greater the
amount of virus present (viral load), the fewer cycles required to
detect the virus.
In a recent study published by Pilarowski et al. in the
peer-reviewed journal Clinical Infectious Diseases,
researchers in California assessed
BinaxNOW in a community-based setting in people of all ages with
and without symptoms. They demonstrated high sensitivity and
specificity for BinaxNOW, including in asymptomatic people and in
children. Among 102 people who were asymptomatic or whose symptom
onset was greater than 7 days before testing, sensitivity for a Ct
cutoff of 30 was 100% and specificity was 98.9%. As Ct counts
increased to 35 (therefore reflecting less viral load) performance
remained high in asymptomatic people of all ages, showing 97.5%
sensitivity and 99.7% specificity.
As part of its Emergency Use Authorization for self-testing,
Abbott has committed to complete a post-authorization study to
determine serial testing performance in people without
symptoms.
About BinaxNOW™ COVID-19 Ag Card Self
Test
The BinaxNOW COVID-19 Ag
Card Self Test is a lateral flow immunoassay intended for
the qualitative detection of nucleocapsid protein antigen from
SARS-CoV-2. This test is authorized for home use with
self-collected direct anterior nasal (nares) swab samples from
individuals aged 15 years or older or adult collected nasal swab
samples from individuals aged two years or older with or without
symptoms or other epidemiological reasons to suspect COVID-19
infection, when tested twice over three days with at least 36 hours
between tests.
Individuals who test negative and continue to experience
COVID-like symptoms should seek follow up care from their
healthcare provider. Individuals who test positive should take
precautions, isolate and seek follow-up care from their healthcare
provider. BinaxNOW COVID-19 Ag Card Self
Test is only for use under the Food and Drug
Administration's Emergency Use Authorization.
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 109,000
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.
The BinaxNOW™ COVID-19 Antigen Self Test is a lateral flow
immunoassay intended for the qualitative detection of nucleocapsid
protein antigen from SARS-CoV-2 from individuals with or without
symptoms or other epidemiological reasons to suspect COVID-19
infection when tested twice over three days with at least 36 hours
between tests. This test is authorized for non-prescription home
use with self-collected direct anterior nasal (nares) swab samples
from individuals aged 15 years or older or adult collected anterior
nasal swab samples from individuals aged two years or
older.
The BinaxNOW COVID-19 Ag 2 Card is authorized for use with
direct anterior nasal (nares) swab samples from individuals without
symptoms or other epidemiological reasons to suspect COVID-19, when
tested twice over three days with at least 36 hours between
tests. Testing is limited to laboratories certified under the
Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42
U.S.C. §263a, that meet the requirements to perform moderate, high,
or waived complexity tests. This test is authorized for use at the
Point of Care (POC), i.e., in patient care settings operating under
a CLIA Certificate of Waiver, Certificate of Compliance, or
Certificate of Accreditation.
The BinaxNOW COVID-19 Ag tests have not been FDA
cleared or approved. They have been authorized by the FDA under an
emergency use authorization. The tests have been authorized only
for the detection of proteins from SARS-CoV-2, not for any other
viruses or pathogens, and are only authorized for the duration of
the declaration that circumstances exist justifying the
authorization of emergency use of in vitro diagnostics for
detection and/or diagnosis of COVID-19 under Section 564(b)(1) of
the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §
360bbb-3(b)(1), unless the declaration is terminated or
authorization is revoked sooner.
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SOURCE Abbott