Coronavirus Disease (COVID-19)
may 12, 2020 | SOURCE: LABCORP
BURLINGTON, N.C. — LabCorp (NYSE: LH), a leading global life sciences company that is deeply integrated in guiding patient care, today announced that its COVID-19 at-home collection test kit is now being offered to individuals nationwide who have symptoms consistent with COVID-19 infection and individuals without symptoms who may have been exposed to the virus. The test is available through the company’s Pixel by LabCorp™ online platform. Initially, the at-home collection test kits were made available in April to frontline healthcare workers and first responders and this latest move expands access in line with U.S. CDC guidelines.
LabCorp’s COVID-19 at-home test kit is physician-authorized and enables individuals to self-collect nasal swab specimens at home. This collection method helps minimize transmission of the virus and the use of personal protective equipment (PPE) as it does not require an in-person visit to a medical professional. Individuals can obtain the test with no upfront out-of-pocket costs if they qualify after completing a COVID-19 health screening questionnaire on the Pixel by LabCorp online platform. LabCorp now has over 200,000 at-home collection test kits available and is prepared to significantly expand capacity as required.
“LabCorp has been leading the industry in developing and bringing high-quality diagnostic tests to market, and we continue to make those tests more accessible to people in need,” said Adam Schechter, president and CEO of LabCorp. “Expanding access to our at-home collection test kit is another example of our response to this health crisis and makes it possible for individuals needing testing to perform the collection without having to leave their home.”
LabCorp also offers a COVID-19 antibody blood test which can be helpful to understand if an individual has developed antibodies to the virus that causes COVID-19. The antibody test is also available with no upfront cost for the test on LabCorp.com, or through a doctor, including through telemedicine programs. To learn more about the antibody test or access the antibody test online, go to LabCorp.com.
The test kit received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on April 20. LabCorp’s COVID-19 test at-home collection kit has been authorized by the FDA under an EUA only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and has not been FDA cleared or approved. 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.
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.
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 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.