#LCSM Chat Topic 1/15 at 8PM ET: “Should the FDA Regulate Which Cancer Tests You Can Have?”

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