Business Wire05.12.20
LabCorp, a global life sciences company deeply integrated in guiding patient care, 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’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.
