INDUSTRY NEWS

FDA approves coronavirus first in-house test

Published Date | 2020 April 29

On 21 April 2020, the Food and Drug Administration said it had given emergency approval for the coronavirus' first in-home test, a nasal swab kit that LabCorp would market. The agency said LabCorp had submitted data showing that the home test is as secure and reliable as a set of samples in a doctor's office, hospital or other testing site.

"With this move, there is now a simple and secure way to obtain patient samples from the comfort and safety of their home," FDA commissioner Dr Stephen M. Hahn said in a statement. Patients must swab their own nose using a company-sent test kit and mail it back to the client in an insulated package. The Pixel by LabCorp COVID-19 test will be available in most states, with the approval of a doctor, the agency said.

LabCorp said it will first make the tests available to health care personnel and emergency responders who may have been exposed to COVID-19 or are symptomatic, and make the self-collection kits available for use in most states, according to the department, with a doctor's order. LabCorp said that it would first make the tests available to health care workers and emergency workers who may have been exposed to COVID-19 or are symptomatic, and that it will make the self-collection kits accessible to customers 'in the coming weeks.' The company also noted that because the tests are carried out by customers in their own homes, the demand for masks and other supplies will be reduced.

The LabCorp said the test cost around $119. Consumers would have to pay for the test out of pocket, a spokesperson for the company said, and ask their insurer for a refund. The Trump administration has consistently said that coronavirus diagnostic tests should be protected in such a way that customers will not have to foot the bill. Around a time when governors around the country complain that their states are facing a shortage of samples, and companies such as CVS and Walmart are opening up drive-through test centers in parking lots, the introduction of kits that allow people to obtain their own nasal specimens around home has the potential to open samples to a wider audience.

Medical experts said home-swabbing tests would improve customer convenience — and reduce people's need to go to medical offices where they could unwittingly expose health care providers and other patients to the infection.