BRIEF-U.S. FDA Finalizes Guidances For Next Generation Sequencing Based Tests

April 12 (Reuters) - FDA:

* U.S. FDA FINALIZES GUIDANCES TO ACCELERATE THE DEVELOPMENT OF RELIABLE, BENEFICIAL NEXT GENERATION SEQUENCING-BASED TESTS

* GUIDANCES PROVIDE RECOMMENDATIONS FOR DESIGNING, DEVELOPING, VALIDATING TESTS THAT USE NEXT GENERATION SEQUENCING

* FIRST GUIDANCE IS TEST DEVELOPERS MAY RELY ON CLINICAL EVIDENCE FROM FDA-RECOGNIZED PUBLIC DATABASES TO SUPPORT CLINICAL CLAIMS FOR TESTS

* SECOND GUIDANCE DESCRIBES WHAT FDA WOULD LOOK FOR IN PREMARKET SUBMISSIONS TO DETERMINE A TEST’S ANALYTICAL VALIDITY Source text : (bit.ly/2qvvf9E)