Response to the Proposed Food and Drug Administration Regulation of Laboratory-Developed Tests: It Is Past Time for Professional Consensus.

Abstract

In October 2014, the US Food and Drug Administration (FDA)2 released a long-promised draft regulatory guidance document outlining the FDA's plan to regulate one of the most innovative areas of laboratory medicine—laboratory-developed tests (LDTs) (1). While the document and public discussion was extremely broad, the draft guidance and subsequent official public interactions often highlighted LDTs by using molecular biology techniques, next-generation sequencing, and mass spectrometry. The majority of the released comments from laboratory and public health professionals involved in patient care and public health activities opposed the draft …