- Center on Health Equity and Access
- Clinical
- Health Care Cost
- Health Care Delivery
- Insurance
- Policy
- Technology
- Value-Based Care
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.
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.
Oncology Onward: A Conversation With Penn Medicine's Dr Justin Bekelman
December 19th 2023Justin Bekelman, MD, director of the Penn Center for Cancer Care Innovation, sat with our hosts Emeline Aviki, MD, MBA, and Stephen Schleicher, MD, MBA, for our final episode of 2023 to discuss the importance of collaboration between academic medicine and community oncology and testing innovative cancer care delivery in these settings.
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