Delfi Diagnostics received approval from the New York State Department of Health to offer its FirstLook Lung laboratory-developed test (LDT) across the state. The cfDNA-based liquid biopsy assay is intended for blood-based lung cancer screening, with Delfi stating it is also working toward U.S. FDA approval. The company said New York’s review milestone enables patient access in all 50 states, contingent on subsequent FDA clearance, and referenced earlier clinical evidence showing FirstLook Lung raised screening rates nearly threefold in a study enrolling nearly 3,000 patients. This approval highlights how state-by-state LDT pathways can accelerate commercial rollout for AI- and cfDNA-enabled oncology screening tools, even ahead of FDA determinations.
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