Stakeholders Urge Congress To Take Up Diagnostic Reform This Year

A coalition of over 80 groups, including manufacturers, providers, laboratories and patient advocates, sent a letter Wednesday (May 9) to key members of Congress attempting to create momentum around passing legislation in 2018 revising government oversight of diagnostics, including laboratory developed tests (LDTs). The unified call for congressional movement comes as FDA is providing technical assistance on a yet-to-be-released revised piece of legislation, which was introduced as a discussion draft last year, according to the letter. While stakeholders see legislation...