Coalition, FDA Talk Alternative LDT Approach; But Proposal Lacks Support in Congress

Updated Story A coalition of diagnostic manufacturers and clinical laboratories is meeting with the FDA to discuss a proposal to divvy up oversight of laboratory developed tests (LDTs) among FDA, CMS and the states, in an apparent bid to drum up FDA support for the legislative alternative that was informally floated earlier this year but failed to make it into the House Cures bill and appears to have little support in the Senate due to lobbying from...