Segment 2: Buyer Beware in the Diagnostic Test Market

There are currently 2 ways diagnostic tests can make it to market in the US: either through the FDA or laboratory-developed tests. This dual-pathway situation has led to a “buyer beware” market, according to Daniel F. Hayes, MD.

Since the FDA does not require clinical utility for clearance or approval, which has resulted in a market with a number of FDA-approved tests that may not be worth much in terms of taking care of patients. In contrast, there are laboratory-developed tests that are quite good, but haven’t been approved, Dr Hayes explained.

“Right now it’s really a mess and many of us believe that it needs to be clarified,” he said.