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Coronavirus (COVID-19) Update: FDA Authorizes First Direct-to-Consumer COVID-19 Test System

For Immediate Release:

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Today, the U.S. Food and Drug Administration authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit for use by any individual 18 years and older without a prescription. This product, which is authorized as the first COVID-19 direct-to-consumer (non-prescription) test system, allows an individual to self-collect a nasal swab sample at home and then send that sample for testing to LabCorp. Positive or invalid test results are then delivered to the user by phone call from a health care provider. Negative test results are delivered via email or online portal.

This home sample collection kit can be purchased online or in a store without a prescription. It is intended to enable users to access information about their COVID-19 infection status that could aid with determining if self-isolation (quarantine) is appropriate and to assist with health care decisions after discussion with a health care professional.

“This is the first kit for consumers to self-collect a nasal sample for COVID-19 in their home that does not require a prescription,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “While many home collection kits can be prescribed with a simple online questionnaire, this newly authorized direct-to-consumer collection kit removes that step from the process, allowing anyone to collect their sample and send it to the lab for processing.”

Photo courtesy of LabCorp (Photo: Business Wire) | Pixel by LabCorp™ COVID-19 Test Home Collection Kit is first to receive FDA authorization for over-the-counter purchase

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

LabCorp Receives FDA Authorization to Make At-Home COVID-19 Collection Kits Available Through Retail

BURLINGTON, N.C. –(BUSINESS WIRE)–Dec. 9, 2020– LabCorp (NYSE: LH), a leading global life sciences company that is focused on advancing health and guiding patient care decisions, today announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for the Pixel by LabCorp™ COVID-19 Test Home Collection Kit to become the first to be available over the counter without requiring a prescription. The kit is currently available through the Pixel by LabCorp website, and this approval will enable LabCorp to potentially distribute the kit through retail channels.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201209006036/en/

This authorization is the latest example of LabCorp’s commitment to increase access to COVID-19 testing. The kit allows consumers to self-collect their sample in the privacy of their own home, which helps minimize transmission of the virus. Users then send the sample for processing at LabCorp .

“With the first over-the-counter at-home collection kit ever authorized by the FDA for COVID-19, we are empowering people to learn about their health and make confident decisions,” said Dr. Brian Caveney, chief medical officer and president of LabCorp Diagnostics . “With this authorization, we can help more people get tested, reduce the spread of the virus and improve the health of our communities.”

Upon purchase, users register their Pixel by LabCorp COVID-19 collection kit at the Pixel by LabCorp website and follow the instructions included. Test results are securely delivered to the consumer via the Pixel by LabCorp portal. A healthcare provider will counsel consumers who test positive to assist with healthcare treatment and actions. The Pixel by LabCorp COVID-19 collection kit is not a substitute for visits to a healthcare professional and is for use in adults 18 and older.

Retailers interested in selling Pixel by LabCorp COVID-19 collection kits can contact the company at PixelPartners@LabCorp.com.

LabCorp’s COVID-19 PCR test has not been FDA cleared or approved, has been authorized by FDA under an Emergency Use Authorization (EUA), and has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The test 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.

About LabCorp

LabCorp (NYSE: LH), an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostics solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported revenue of more than $11.5 billion in 2019. To learn more about LabCorp , visit www.LabCorp.com.

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 or 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 its 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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LabCorp Contacts:
Media: Chris Allman-Bradshaw – 336-436-8263
Media@LabCorp.com

Investors: Clarissa Willett – 336-436-5076
Investor@LabCorp.com

Source: LabCorp

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SOURCES: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-direct-consumer-covid-19-test-system; https://ir.labcorp.com/news-releases/news-release-details/labcorp-receives-fda-authorization-make-home-covid-19-collection

Categories: National Headlines