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Pixel by Labcorp COVID-19 PCR Test Home Collection Kit Receives FDA Emergency Authorization for Ages 2-17

May 13, 2021 Off By BusinessWire

Labcorp Becomes First Major Commercial Lab to Offer a COVID-19 PCR Test Home Collection Kit for Children 2 Years and Older

BURLINGTON, N.C.–(BUSINESS WIRE)–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.

“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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