FDA starts clock on LDT regulation

On Tuesday, FDA released two draft guidance documents that outline the agency's plans for regulating laboratory-developed tests (LDTs). The draft guidance is largely in line with documents pre-released in July (see BioCentury, August 11).

Amendments include an updated definition of companion diagnostics to reflect FDA's Aug. 6 final guidance on companion diagnostics, and a technical amendment to the agency's choice of wording regarding traditional LDTs. ...