Pixel by Labcorp COVID-19 PCR Test Home Collection Kit Receives FDA Emergency Authorization for Ages 2-17
May 13 2021 - 8:57AM
Business Wire
Labcorp Becomes First Major Commercial Lab to
Offer a COVID-19 PCR Test Home Collection Kit for Children 2 Years
and Older
Labcorp (NYSE: LH), a leading global life sciences company,
today announced that the U.S. Food and Drug Administration (FDA)
has granted Emergency Use Authorization (EUA) for its Pixel by
Labcorp COVID-19 PCR Test Home Collection Kit for ages 2-17. The
authorization expands the use of Pixel by Labcorp to children and
adolescents 2 years of age and older when purchased by a parent or
guardian.
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the full release here:
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Photo courtesy of Labcorp
“Expanding access of our Pixel by Labcorp COVID-19 Test Home
Collection Kit to include younger populations fills an important
need as people seek to resume life activities safely,” said Brian
Caveney, M.D., chief medical officer and president of Labcorp
Diagnostics. “This is welcome news as children and parents look
forward to summer activities, camps, travel and the upcoming school
year.”
Pixel by Labcorp COVID-19 PCR Home Collection Kit uses the same
PCR test trusted by doctors and hospitals across the country.
Individuals age 14-17 can self-collect with adult supervision, and
children between the ages of 2 and 13 will need adult assistance to
collect their sample.
Beginning in late May, parents and guardians can request a kit
for children 2 years of age and older directly through
www.pixel.labcorp.com. Once the request is received by Labcorp, a
kit will be shipped to the individual’s home via FedEx. For adults
18 and over, the Pixel by Labcorp COVID-19 PCR Test Home Collection
Kit is also available in over 6,000 pharmacies nationwide.
Labcorp offers its Pixel by Labcorp COVID-19 PCR Test Home
Collection Kit for zero upfront costs when clinical guidelines are
met. Visit Labcorp’s COVID-19 website to learn about the company’s
testing and drug development offerings.
The Pixel by Labcorp COVID-19 PCR Test Home Collection Kit has
not been FDA-cleared or approved, but has been authorized for
emergency use by FDA under an EUA, and has been authorized only for
the detection of nucleic acid from SARS-CoV-2, not for any other
viruses or pathogens. Emergency use of this product is 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.
About Labcorp
Labcorp is a leading global life sciences company that provides
vital information to help doctors, hospitals, pharmaceutical
companies, researchers, and patients make clear and confident
decisions. Through our unparalleled diagnostics and drug
development capabilities, we provide insights and accelerate
innovations to improve health and improve lives. With more than
70,000 employees, we serve clients in more than 100 countries.
Labcorp (NYSE: LH) reported revenue of $14.0 billion in FY2020.
Learn more about us at www.Labcorp.com or follow us on LinkedIn and
Twitter @Labcorp.
Labcorp Cautionary Statement Regarding Forward-Looking
Statements
This press release contains forward-looking statements,
including but not limited to statements with respect to clinical
laboratory testing and the potential benefits of a COVID-19 test
home collection kit and our responses to and the expected future
impacts of the COVID-19 pandemic and the opportunities for future
growth.
Each of the forward-looking statements is subject to change
based on various important factors, many of which are beyond the
Company’s control, including without limitation, whether our
response to the COVID-19 pandemic will prove effective, the impact
of the COVID-19 pandemic on our business and financial condition,
as well as on general economic, business, and market conditions,
competitive actions and other unforeseen changes and general
uncertainties in the marketplace, changes in government
regulations, including healthcare reform, customer purchasing
decisions, including changes in payer regulations or policies,
other adverse actions of governmental and third-party payers, the
Company’s satisfaction of regulatory and other requirements,
patient safety issues, changes in testing guidelines or
recommendations, federal, state, and local governmental responses
to the COVID-19 pandemic, adverse results in material litigation
matters, failure to maintain or develop customer relationships, our
ability to develop or acquire new products and adapt to
technological changes, failure in information technology, systems
or data security, and employee relations. These factors, in some
cases, have affected and in the future (together with other
factors) could affect the Company’s ability to implement the
Company’s business strategy and actual results could differ
materially from those suggested by these forward-looking
statements. As a result, readers are cautioned not to place undue
reliance on any of our forward-looking statements.
The Company has no obligation to provide any updates to these
forward-looking statements even if our expectations change. All
forward-looking statements are expressly qualified in their
entirety by this cautionary statement. Further information on
potential factors, risks and uncertainties that could affect
operating and financial results is included in the Company’s most
recent Annual Report on Form 10-K and subsequent Forms 10-Q,
including in each case under the heading RISK FACTORS, and in the
Company’s other filings with the SEC.
# # #
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version on businesswire.com: https://www.businesswire.com/news/home/20210513005610/en/
Labcorp Contacts: Media: Christopher Allman-Bradshaw —
336-436-8263 Media@Labcorp.com
Investors: Chas Cook — 336-436-5076 Investor@Labcorp.com
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