LDT rules

[anonymous]

What effect with the proposed rules on LDTs have on bioreference labs? Aren't many of the women's health tests LDTs?

FDA Issues Long-Awaited Proposed Rule To Regulate Laboratory-Developed Tests | Insights | Skadden, Arps, Slate, Meagher & Flom LLP).

 

[anonymous]

Almost everything we run is LDT. We do it because it is cheaper than an FDA test. It means, almost every molecular test in women's health needs to be converted over or we won't get paid. Big problem!

 

[anonymous]

What effect with the proposed rules on LDTs have on bioreference labs? Aren't many of the women's health tests LDTs?

FDA Issues Long-Awaited Proposed Rule To Regulate Laboratory-Developed Tests | Insights | Skadden, Arps, Slate, Meagher & Flom LLP).

Follow the rules and the leadership from your superiors (aka everyone) at the home of the whopper. Nothing else is your concern.

hope this helps