BURLINGTON, N.C.--(BUSINESS WIRE)--LabCorp (NYSE: LH) today launched the LabCorp At Home COVID-19 Test Collection Service, the first seamless digital service aimed at helping doctors protect patients by testing them for COVID-19 before surgeries and other important treatments. The service received Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) on July 1, 2020.
The service enables a doctor to directly order a LabCorp At Home COVID-19 test collection kit for their patient through a digital interface with LabCorp. Once the order is placed, LabCorp will send the COVID-19 kit to the patient, who will perform the sample collection using a nasal swab and send it back to LabCorp via FedEx. LabCorp will then deliver the patient’s test results to the healthcare provider’s electronic medical record (EMR) and the patient’s LabCorp Patient Portal, making the process seamless for the doctor and patient. The result provides the doctor the information needed to make the appropriate clinical decision prior to proceeding with surgery or other treatment. LabCorp is piloting the service with select providers initially, and plans to make the service available to more health systems, hospitals, and surgical centers through the providers’ EMRs in coming weeks.
Dr. Brian Caveney, chief medical officer and president of LabCorp Diagnostics, said: “The continuing COVID-19 crisis has forced the delay of many appointments, screenings and surgeries, putting people with serious medical conditions at increased risk. Our LabCorp At Home Service is simple for doctors to order and convenient for patients to use, enabling surgeries and other important treatments to get back on track so patients can manage and improve their health.”
This home collection kit has not been FDA cleared or approved. This home collection kit has been authorized by the FDA under an EUA. This home collection kit has been authorized only for the home collection and maintenance of nasal swab specimens as an aid in detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This home collection kit, in combination with the authorized 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.
For more information, visit https://www.labcorp.com/labcorp-home-kit-provider-information.
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.
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 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.
# # #