It's policy not law (the law give the FDA authority to set policy and makes decisions). And they definitely would consider the sensitivity and specificity and

It's policy not law (the law give the FDA authority to set policy and makes decisions). And they definitely would consider the sensitivity and specificity and PPV of a test. TBH it's amazing it got approved. But the product leadership and founding team definitely knew how to play the FDA game. Yes, early cancer tests are fantastic. However, tests need to have extremely good sensitivity and specificity for exactly the reason you said.