LabCorp is a global life sciences company that provides comprehensive clinical laboratory and end-to-end drug development services
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.
Source: Company Press Release