pipeline update, page-4

Hi Metal

My understanding was that Quest intended to release lungdx as a "Laboratory Developed Test" (LDT) in the first instance. For a delivered and validated by the largest diagnostic company in the US the process is essentially a fait accompli.

The FDA does not generally review LDTs. Reliance is placed on lab compliance with FDA approved validation and quality assurance processes.

Notwithstanding significant tail dragging and ongoing delays, extensive validation processes (now complete according to the pipeline diagram) could at some stage support a 510K application. This level of approval would enable sale of the test to other providers (if desired).

cheers