Paul A. Bunn, Jr., MD, Lung Cancer: Giant of Cancer Care, professor of medicine in medical oncology, head of the division of medical oncology, University of Colorado, discusses the pros and cons of having companion diagnostic tests in lung cancer.
Bunn says the FDA wants everyone enrolled on a study to have the same test, which would then be approved. This becomes a problem, Bunn says, if the test is proprietary because everyone would have to send samples to one lab to be tested. Having a public test would allow physicians to get the tests done anywhere, resulting in a faster turn-around time.
Bunn says he believes that a laboratory test for a specific analyte is better than having companion diagnostics.
However, the FDA recently announced that it is issuing a final guidance on the development, review and approval or clearance of companion diagnostics. The guidance is meant to help facilitate the diagnosis and treatment of patients through accurate, consistent, and reliable results.
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