On Friday, November 18th, the Food and Drug Administration (FDA) announced that it would not seek to finalize its guidance on laboratory developed tests (LDTs) prior to the Trump Administration taking office. Since then, the agency has elaborated on some of the details of this announcement, claiming:
While excessive oversight can discourage innovation, inadequate and inconsistent oversight in which different test developers are treated differently can also discourage innovation by making it difficult for high-quality test developers to compete with poorer performing counterparts.
Among the concerns addressed in the statement, a level playing field for traditional device manufacturers and independent laboratories referenced in the announcement.
While this news brings a little more clarity for the direction of lab-developed tests regulation by the FDA, the lack of a finalized guidance leaves the developers of LDTs, including In Vitro Diagnostic Multivariate Index Assays (IVDMIAs) in limbo.