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LabCorp COVID-19 At-Home Test Kit Receives FDA Emergency Use Authorization

Initial Distribution Prioritized for Frontline Healthcare Workers and First Responders

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Summation

  • 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.

LabCorp Covid-19 at Home Test Kit: LabCorp (NYSE: LH), a leading global life sciences company that is deeply integrated in guiding patient care, today announced that it has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).

The EUA permits nasal swab specimens to be collected at home using the Pixel by LabCorp™ COVID-19 test home collection kit if recommended by a healthcare provider after completing a COVID-19 questionnaire.

LabCorp’s COVID-19 at-home test kit is part of the company’s continued commitment to increase the supply and availability of tests for healthcare workers and first responders who have symptoms consistent with COVID-19. Enabling individuals to self-administer sample collection will help prevent the risk of transmitting the virus to others and reduces the demand for personal protective equipment (PPE) as the tests do not require a clinician to perform the test collection.

“LabCorp continues to develop new ways to help patients and healthcare providers fight the COVID-19 crisis through our leading testing capabilities and deep scientific and research expertise,” said Adam Schechter, president and CEO of LabCorp. “Our at-home collection kits are designed to make it easier and safer to test healthcare workers and first responders during this important time.”

The kits will be offered through the company’s Pixel by LabCorp platform and initially be made available to healthcare workers and first responders who may have been exposed to COVID-19 or may be symptomatic. LabCorp intends to make COVID-19 self-collection kits available to consumers in the coming weeks. Future updates about the self-collection kits can be found on LabCorp’s COVID-19 microsite.

LabCorp’s COVID-19 test home collection kit has not been FDA cleared or approved, has been authorized 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. 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.

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Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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