• Center on Health Equity & Access
  • Clinical
  • Health Care Cost
  • Health Care Delivery
  • Insurance
  • Policy
  • Technology
  • Value-Based Care

Segment 2: Buyer Beware in the Diagnostic Test Market

Article

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.

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.

Related Videos
Drs Yelena Janjigian and Zev Wainberg | Background image credit: ipopba - stock.adobe.com
Nicoletta Colombo, MD, PhD
Oncology experts at PCOC
Joshua K. Sabari, MD
Joshua K. Sabari, MD
Nicoletta Colombo, MD, PhD
Dr Brian Mulherin
Dr Brian Koffman
Dr Brian Mulherin
Related Content
© 2025 MJH Life Sciences
AJMC®
All rights reserved.