LabCorp Offers Home Testing Kit for COVID-19
Healthcare workers and first responders who have symptoms of COVID-19 now can use a LabCorp kit to self-test for the coronavirus at home.
The Burlington-based life sciences company has received Emergency Use Authorization (EUA) from the Food and Drug Administration, which allows patients to collect nose swab specimens with LabCorp’s Pixel COVID-19 kit. It is the first coronavirus diagnostic test authorized by the FDA that has a home collection option.
A doctor or other healthcare provider must recommend the test after the patient completes a COVID-19 questionnaire. The swab sample is sent back to LabCorp for analysis. The test confirms whether an individual has been infected with SARS-CoV-2, the virus that causes COVID-19.
While the FDA hasn’t officially approved the kit, it has authorized its use. Under EUA guidelines, the agency can sign off on unapproved medical products that diagnose, treat or prevent serious or life-threating diseases during a health crisis.
“Throughout this (coronavirus) pandemic we have been facilitating test development to ensure patients access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options,” FDA Commissioner Stephen M. Hahn, M.D., said in a statement. “We worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital or other testing site.”
The company said the EUA designation makes it easier and safer to evaluate healthcare workers and first responders with COVID-19 symptoms. Self-administered home testing lowers the risk of transmitting the virus and reduces the use of personal protective equipment.
“LabCorp continues to develop new ways to help patients and healthcare providers fight the COVID-19 crisis through our leading testing capabilities and deep scientific and research expertise,” said Adam Schechter, president and CEO.
The company said it plans to make the kits more broadly available to consumers soon.
LabCorp, founded almost 51 years ago in Burlington, is an international life sciences powerhouse. Today the company is an $11.5 billion business with more than 65,000 employees. It operates one of the largest clinical laboratory networks in the world.