—There is no place in science for consensus or opinion, only evidence.-Claude Bernard
Dear Senator Warren,
Thank you for your reply regarding laboratory developed tests (LDTs) and the need for regulatory oversight. As you mention, LDTs are developed without FDA approval—a pathway in which is not even necessary to prove validity of a test (that it is actually testing what it claims to be testing for) to bring it to market. With no FDA oversight or regulation a commercial lab can claim any validity they want in marketing these tests. The regulation debate has focused on the reliability and validity of a number of clinical tests marketed with unverified claims of accuracy such as prenatal screening and Lyme disease and this lack of oversight is a direct threat to patient safety.
I am sure you would agree with me that the importance of tests diagnostic accuracy is directly proportional to its…
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