> The two kinds of testing — surveillance and diagnostic — fall under different F.D.A. standards. In a pure surveillance study, the researchers may keep the results just for themselves. But coronavirus testing has largely revolved around getting results returned to doctors who can share the results with patients.
> “We had previously understood that SCAN was being conducted as a surveillance study,” the spokesperson said.
...
> Dr. Topol said it would not make sense to have people swab their noses and then not give them their test results.
> “To withhold that information from people is downright absurd,” Dr. Topol said.
While I agree with the sentiment, the 23andme situation provides a useful counter balance: if you provide untrained people with inaccurate results, is that better or worse?
In the 23andme case there was a worry that people might commit suicide or make massive life changes, if they discovered they had a potential terminal illness. Here, the 2x2 matrix of positive vs negative and true vs false, seems most dangerous on the false-positive side for people who believe it grants them freedom to do whatever they like. False negatives are dangerous for those who then feel certain they don’t have the disease currently and thus expose others unwittingly (but this is already likely!).
So I dunno, I bet they’ll review this somewhat quickly (the group sent their FDA materials in a few weeks ago according to the article) particularly once they have a tighter estimate on the false positive and negative rates.