Tag Archives: lab-developed tests

Debate over regulating lab-developed tests about to heat up

Joseph Burns

About Joseph Burns

Joseph Burns (@jburns18), a Massachusetts-based independent journalist, is AHCJ’s topic leader on health insurance. He welcomes questions and suggestions on insurance resources and tip sheets at joseph@healthjournalism.org.

Photo: Lori Greig via Flickr

Photo: Lori Greig via Flickr

Sometime this year, the U.S. Food and Drug Administration is expected to issue guidance to clinical laboratories that produce lab-developed tests (LDTs). Clinical labs that offer LDTs, and associations that represent these labs, have criticized the FDA’s oversight proposal and are challenging the agency’s authority to regulate these tests.

Many of us will be writing about LDTs, their value to patients and the need for a review of how these tests are produced, whether the results are clinically valid, and whether their marketing claims are accurate. Continue reading