4 ms·
That corresponds to the publication, https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)01700-2/fulltext?rss=yes https://www.thelancet.com/journ
by dekhn 3y ago
That corresponds to the publication, https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)01700-2/fulltext?rss=yes https://www.thelancet.com/journals/lancet/article/PIIS0140-6...
"A cancer signal was detected in 92 (1·4%) of 6621 participants with analysable results. 35 (38%) participants were diagnosed with cancer (true positives) and 57 (62%) had no cancer diagnosis (false positives)."
I am surprised that they were approved based on their study results, it will be interesting to see the results from PATHFINDER 2, which is running now.
- nradov 3y agoIf there a legal reason that the test shouldn't be approved? Although the false positive rate is high, it's ultimately up to the patient and their doctor about whether to order the test and what to do with the results. I do understand the concerns over false positives unnecessarily scaring patients and leading to wasteful additional diagnostic tests, but I don't think the FDA really accounts for that in the approval process. Detecting early stage cancer in a liquid biopsy is extremely difficult so it's impressive that they made it work at all.
- dekhn 3y agoIt'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.