The authorization from the New York State Department of Health makes the screening test available in all 50 states.
DELFI Diagnostics announced it has received a Clinical Laboratory Permit and Test Approval letter from the New York State Department of Health (NYSDOH). With this permit, the company is authorized to offer its FirstLook Lung laboratory-developed test (LDT) in New York, making the screening tool available in all 50 US states.
The NYSDOH is recognized as the most “rigorous” state-level clinical laboratory regulatory authority in the US, requiring formal review and approval of LDTs, according to a company release. Earning this permit completes the company’s credentialing portfolio, which includes Clinical Laboratory Improvement Amendments certification, College of American Pathologists accreditation, and International Organization for Standardization 13485 and 27001 certifications.
“This is about access,” says Susan Tousi, CEO of DELFI Diagnostics, in a release. “There are millions of people across the country who are eligible for lung cancer screening and aren’t getting it, and clearing New York’s review process for our AI-powered LDT means we can now reach patients in every state with a test that has been held to the most exacting standards in clinical laboratory regulation. It also puts a meaningful marker on our path to FDA approval.”
FirstLook Lung is designed for individuals eligible for lung cancer screening based on United States Preventive Services Task Force criteria. The technology uses artificial intelligence to analyze patterns of circulating cell-free DNA fragments in the blood, an approach known as fragmentomics. The test is intended to identify individuals at elevated risk for lung cancer and guide them toward follow-up with low-dose computed tomography scans.
The company reports the test has a negative predictive value of 99.8%. While FirstLook Lung is now available across the US, it has not yet been cleared or approved by the Food and Drug Administration (FDA).
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