Labcorp announced it is working with the U.S. Department of Health and Human Services (HHS) to raise awareness of potentially lifesaving monoclonal antibody COVID-19 therapies.
Patients who test positive using Labcorp’s COVID-19 PCR test will receive information about monoclonal antibody therapeutics with their result. Additionally, Labcorp’s COVID-19 site provides information about treatments and vaccines, including monoclonal antibody therapies, and answers a variety of questions related to testing options. As of May 7, Labcorp has processed more than 41 million COVID-19 PCR tests.
Monoclonal antibody treatments are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as the virus that causes COVID-19. Two such treatments currently have emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA).
People who are at high risk for progressing to severe COVID-19 or hospitalization can potentially reduce their risk of becoming very ill by receiving a monoclonal antibody treatment within the first 10 days of illness. Early evidence suggests that monoclonal antibody treatments can reduce the amount of SARS-CoV-2, the virus that causes COVID-19, in a person’s system, which decreases the likelihood of severe symptoms and hospitalization.
Meredith Chuk, M.D., federal lead for the monoclonal antibody program, said, “This treatment is readily available and can decrease the likelihood that high-risk patients who test positive for the virus will develop severe disease or require hospitalization.”
Labcorp’s COVID-19 PCR test has not been FDA-cleared or approved; it 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. The test is authorized only 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.
