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What You Need to Know About FDA's Proposed Regulation of LDTs

MDDI interviewed Of Counsel Benjamin Zegarelli on the controversy surrounding the FDA’s proposed regulation to oversee laboratory-developed tests (LDT) and his thoughts on the future of LDTs.

Benjamin noted, “As laboratory tests become more sophisticated and intended to detect or help diagnose more serious diseases and conditions, the risk to patients from false negatives and false positives rises, as well. FDA has noted this rise in risks associated with LDTs and is taking the position that active regulatory oversight and quality controls are necessary to mitigate such risks.”