Lumea: The FDA's recent move to treat Laboratory Developed Tests (LDTs) as medical devices has sent ripples through the industry. With the absence of a passed legislation in 2022, the FDA has taken a pivotal step, emphasizing its...

medpagetoday.com posted a brief but concise article earlier this week on the issue of FDA regulating laboratory developed tests (LDTs). While the FDA has had the ability to regulate these tests since 1976, largely once regarded as "simple and...

This is the third (and last) in a series of posts on Laboratory Developed Tests (LDT).  In this installment, I discuss where to find comparative analysis reviews of LDTs and add a few thoughts on LDT policies for pathology departments,...

This is the second in a series of three posts on Laboratory Developed Tests (LDT).  In this installment, I summarize developments in the past few years as the FDA eventually announced its intention to more actively regulate all...

In this series of posts on Laboratory Developed Tests (LDTs), I discuss the history of the regulation of LDTs and impending changes (posts #1 and #2).  I also discuss possible criteria that pathologists, treating physicians, and...