Washington: US Food and Drug Agency approved the first “at-home test” for diagnosing COVID-19, said Dr Stephen Hahn, who heads the agency.
He said the president tasked him with cutting down “as many barriers as we possibly could to get products into the medical community”, the BBC reported.
“We have done that, of course recognising the urgency of the situation,” Dr Hahn says.
“This is a test where, under certain circumstances with a doctor’s supervision, a test can be mailed to a patient, and the patient can perform the self-swab and mail it back and get the results.”
He says the agency has approved 63 tests thus far, and is currently working with over 400 test developers to authorise their products.
When asked about antibody tests – which determine if someone has already had the virus and may be immune – Dr Hahn says they have authorised four and “more are in the pipeline”.
The lack of testing has been a key issue with the country’s COVID-19 response. Governors across the nation have been requesting more tests in recent weeks, and initial tests put forth by the Centers for Disease Control were inaccurate.
Existing drug administration regulations also made it harder at the onset for hospital laboratories across the country to develop new diagnostic tests.
