CONGRESS HAS YET TO SPEAK SPECIFICALLY ON THE ISSUE of regulating laboratory developed tests (LDTs). Influential advocates on both sides of this issue have lobbied lawmakers on this issue for a decade. Given the stakes involved in the specifics of how laboratory developed tests are regulated, it is reasonable to assume that representatives and senators […]
What if Congress Chooses to Pass an LDT-Specific Law?
Despite the FDA’s decision to issue its LDT rule, possibility remains of Congress tackling this subject
- By Robert Michel
- > From the Volume XXXI, No. 8 - June 10, 2024 Issue
- Tags: american association for clinical chemistry, American Cancer Society Cancer Action Network, American Society of Clinical Oncology (ASCO), association for molecular pathology, Association of Pathology Chairs, BD (Beckton, Bio-Rad Laboratories, cap, Center for Science in the Public Interest, Cepheid, College of American Pathologists, Dickson and Co.), Friends of Cancer Research, Hologic, ivd/lab informatics, laboratory-developed tests, ldt, Muscular Dystrophy Association, Ovarian Cancer Research Alliance, Pew Charitable Trusts, Rep. Diana DeGette, Rep. Larry Bucshon MD, roche diagnostics, VALID Act, Verifying Accurate Leading-edge IVCT Development Act
