The US Food and Drug Administration (FDA) announced its intention to regulate laboratory developed tests. Under the FDA’s proposed Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) — which treats LDTs as medical devices and healthcare providers as manufacturers — laboratories would have to submit applications for expensive premarket review for thousands of LDTs if they wish to continue offering them to patients. This could limit access to life-saving genomic testing for patients who have cancer and other conditions treatable with targeted drugs. This Thursday, January 15, 2015, at 8 PM… Read More
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