Delfi Diagnostics said New York State Department of Health approved its FirstLook Lung laboratory-developed test, enabling the company to offer its cfDNA-based liquid biopsy assay to patients across the state. The company positioned the state clearance as a step toward U.S. FDA approval. FirstLook Lung analyzes blood for lung cancer screening signals, and Delfi reported earlier clinical evidence suggesting a near threefold increase in screening uptake in a study nearing 3,000 patients. CEO Susan Tousi emphasized the access goal, linking NY approval to broader reach. Because LDT rules vary by state, NY approval can materially shift deployment speed and patient exposure while Delfi continues evidence generation for a national FDA path. The key watch items are integration into ordering workflows, follow-up confirmation rates after positive screening results, and how performance metrics translate across populations.
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