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.
The Joint Commission is launching the Rural Health Clinic Accreditation Program to standardize staff training and patient care practices at rural health clinics nationwide; the American Cancer Society recently launched the largest-ever study of cancer risk and outcomes in Black women; the HHS COVID-19 vaccination campaign saved $732 billion by preventing illness and related costs.
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