CLC Urges Release of Draft Guidance on Laboratory-Developed Tests
Dear Mr. Zients:
The undersigned organizations represent cancer patients, physicians, and researchers who look forward to continued innovation in the development of diagnostic tests that yield precise information about cancer diagnosis and permit appropriate targeting of treatment. If cancer patients and their physicians are to make life-changing decisions on the basis of diagnostic tests, they must be assured that such tests are reliable and provide clinically meaningful information.
For decades, the standards for introduction of new technology to patients and their
In recognition of the importance of diagnostic tests in patient care, FDA has worked for many years on standards for the evaluation of LDTs. After such a length of time, the draft guidance on these standards should be published for public comment and advice without further delay. We believe that FDA review standards are intended to reassure patients on the reliability and usefulness of diagnostic tests and set clear parameters for developers of new tests. We offer no comment on specific standards at this time but look forward to the opportunity to comment upon release of the draft guidance.
We urge prompt release of draft guidance related to LDTs, with appropriate time for public comment. Many of the undersigned have previously participated in public meetings on this topic and have otherwise offered our advice on LDTs, and we stand ready to participate inpublic comment period.
CANCER LEADERSHIP COUNCIL
American Society for Radiation Oncology
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