ARTICLE | Regulation

LDT blurred Lines

FDA has set the playing field for regulatory, legislative endgame on LDTs

August 11, 2014 7:00 AM UTC

FDA's release of draft guidance in a congressional notice officially put down a marker on the agency's plans for a risk-based framework for regulating laboratory-developed tests. Some stakeholders think the proposed oversight could better align regulatory requirements and the needs of payers. It could also give a competitive advantage to companies that have already generated the necessary data on clinical utility.

Others think the draft does little to alleviate the regulatory uncertainty that has dogged the sector for years. These critics note a slew of questions remain to be answered before investors and companies can be confident that the paradigm of laboratory-developed tests (LDTs) - which straddles a blurry line between device manufacturing and clinical practice - can be slotted into FDA's regulatory stable...