Approved or not? Positive or not? Testing still murky

Regulators are sparring with health tech startups over the intricacies of what, precisely, qualifies as a home test for Covid-19. Although two testing startups told STAT this week that their tests were copacetic for at-home use, the FDA remains adamant that this isn’t the case, STAT’s Erin Brodwin writes. 

One company, MicroGen DX, told STAT it didn’t need FDA approval, because it uses an accredited lab to process results. Another, Vault Health, said it’s been “provisionally cleared” and requires a clinician’s sign-off. 

And in other testing news: There appears to be a large number of false negatives when it comes to coronavirus testing in general, Bloomberg writes. Although patients are showing clear symptoms of the disease, many are still turning up negative results — which of course increases the risk of transmission.