Are Multiplex Assays Approvable? Considerations for Obtaining FDA Clearance or Approval on Multi-Marker Tests
Mon 3:30 PM - Track 2: Patents, FDA, Multiplex
Mya Thomae
Myraqa, Inc.
View Long Abstract
Multiplex assays are becoming state-of-the art in clinical laboratories. Many of these tests have been developed as Laboratory Developed Tests (LDTs) which may be subject to FDA regulation in the next several years. This presentation will cover FDA's current approach to review of multi-marker assays including requirements for analytical studies, performance studies and requirements to demonstrate clinical utility of markers. Specific examples of multimarker tests that have been cleared or approved will be presented along with specific considerations for labs seeking FDA approval of an LDT.