Comment from Danaher Diagnostics

Summary: Danaher Diagnostics (specifically its subsidiary Cepheid) supports the FDA's proposal to reclassify Mycobacterium Tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests from Class III to Class II. They argue this will reduce regulatory burdens and encourage innovation, while also recommending the inclusion of host transcriptional gene tests in the reclassification scope.