Labs that run molecular diagnostic tests are not only worried about getting short-changed on payment for the tests by some Medicare Part B contractors, but that the tests will not be covered at all. “
FDA draft guidance on single-laboratory diagnostics may slow down the introduction of genomic testing in the short term. Over the long term, however, it will help validate the field and create a stron
The new model aims to capture drug-like revenues and margins without taking drug-like development and regulatory risk. By Ellen Foster Licking and Roger Longman Diagnostics have had an image problem f