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LDTs Clearly Remain Troublesome for FDA

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Margaret Hamburg took the opportunity, at the end of a speech honoring a colleague at the annual meeting of the American Society of Clinical Oncology (ASCO), to make some pointed comments that should make LDT developers every more concerned about impending regulation of their wares.

Key quote:
Hamburg then states that the FDA “is working to make sure that the accuracy and clinical validity of high-risks tests are established before they come to market.”

FDA Commissioner Hints At New Diagnostic Test Regulations – Forbes.