(STAT News) – While a great many [Lab-Developed Tests] are routinely used without incident by doctors and hospitals, stronger FDA oversight is long overdue. Certainly, it should help tamp down the exaggerated claims used to market some LDTs.

However, by considering the problem “solved” as long as LDTs and non-LDTs are treated similarly, the FDA proposal obscures a fundamental mathematical limitation to testing, which too many patients and doctors are unaware of: Practically all tests, not just LDTs, carry the risk of false positives, which can render the results effectively useless when the condition is rare enough. (Read More)