The Food and Drug Administration (FDA) today recommended a dramatic shift in how it implements regulations that control whether laboratories can use diagnostic kits created in-house to test for infections of COVID-19. “We issued a policy this morning that allows us to have a lot of flexibility around the development of diagnostic tests,” FDA Commissioner Stephen Hahn said at a White House briefing with President Donald Trump this afternoon. “We expect this policy to have a significant impact.” The change could greatly expand the number of laboratories able to do coronavirus testing.
The U.S. government has come under severe criticism for not providing nearly enough tests needed to understand the extent of spread in the population. A test kit produced and distributed by the U.S. Centers for Disease Control and Prevention (CDC) was shelved after state and local labs trying it out discovered it contained a faulty reagent. As a result, many labs that have the capability to test themselves have not been allowed to do so.
The new recommendations focus on “high-complexity testing laboratories” that are certified under federal rules known as Clinical Laboratory Improvement Amendments. This group of facilities includes many hospital labs, like the one where epidemiologist Michael Mina works at Brigham and Women’s Hospital. “Essentially it’s opening up a clear and concise avenue for labs like the one at Brigham and Women’s,” Mina says. “It’s what I’ve been advocating for a month now.”