Delfi Diagnostics received New York State Department of Health approval to offer its FirstLook Lung laboratory-developed lung cancer screening test. With the approval, Delfi can market its cfDNA-based liquid biopsy assay in all 50 states while it works toward U.S. FDA approval. The company said its AI-powered test previously showed that lung cancer screening rates rose by nearly threefold in a clinical study of about 3,000 patients. FirstLook Lung uses blood-based cfDNA and is offered as an LDT under state regulation, creating an early access pathway ahead of federal review. Delfi framed the move as an access milestone, pointing to the millions of eligible patients not currently receiving screening. For health systems, the faster deployment of an LDT can influence how screening programs expand beyond traditional imaging. The next gating item for the market will be FDA acceptance and how the assay performs under broader clinical and regulatory expectations.
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