{"id":247765,"date":"2026-05-29T14:32:07","date_gmt":"2026-05-29T14:32:07","guid":{"rendered":"https:\/\/www.newsbeep.com\/us-ny\/247765\/"},"modified":"2026-05-29T14:32:07","modified_gmt":"2026-05-29T14:32:07","slug":"delfi-diagnostics-receives-new-york-state-approval-for-lung-cancer-blood-test","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/us-ny\/247765\/","title":{"rendered":"DELFI Diagnostics Receives New York State Approval for Lung Cancer Blood Test"},"content":{"rendered":"

DELFI Diagnostics<\/a> 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.<\/p>\n

The NYSDOH<\/a> is recognized as the most \u201crigorous\u201d 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\u2019s credentialing portfolio, which includes Clinical Laboratory Improvement Amendments certification, College of American Pathologists accreditation, and International Organization for Standardization 13485 and 27001 certifications.<\/p>\n

\u201cThis is about access,\u201d says Susan Tousi, CEO of DELFI Diagnostics, in a release. \u201cThere are millions of people across the country who are eligible for lung cancer screening and aren\u2019t getting it, and clearing New York\u2019s 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.\u201d<\/p>\n

FirstLook Lung is designed for individuals eligible for lung cancer screening<\/a> based on United States Preventive Services Task Force criteria. The technology uses artificial intelligence<\/a> 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.<\/p>\n

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).<\/p>\n

ID 166989276<\/a> \u00a9 Andrii Yalanskyi<\/a> | Dreamstime.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"DELFI Diagnostics announced it has received a Clinical Laboratory Permit and Test Approval letter from the New York…\n","protected":false},"author":2,"featured_media":247766,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[96788,96789,72630,96790,96791,96792,91044,96283,96284,96793,96794,96795,96796,96797,96798,26712,96799,9,11,10,49,2566,51,50,92315],"class_list":["post-247765","post","type-post","status-publish","format-standard","has-post-thumbnail","category-new-york","tag-ai-in-diagnostics","tag-blood-test","tag-cancer-screening","tag-cap-accreditation","tag-cell-free-dna","tag-clia-certification","tag-clinical-laboratory","tag-delfi-diagnostics","tag-fda-approval","tag-firstlook-lung","tag-fragmentomics","tag-iso-certification","tag-lab-accreditation","tag-laboratory-developed-test","tag-ldt","tag-lung-cancer","tag-molecular-diagnostics","tag-new-york","tag-new-york-headlines","tag-new-york-news","tag-new-york-state","tag-new-york-state-department-of-health","tag-new-york-state-headlines","tag-new-york-state-news","tag-regulatory-approval"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/us-ny\/wp-json\/wp\/v2\/posts\/247765","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/us-ny\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/us-ny\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-ny\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-ny\/wp-json\/wp\/v2\/comments?post=247765"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/us-ny\/wp-json\/wp\/v2\/posts\/247765\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-ny\/wp-json\/wp\/v2\/media\/247766"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/us-ny\/wp-json\/wp\/v2\/media?parent=247765"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-ny\/wp-json\/wp\/v2\/categories?post=247765"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-ny\/wp-json\/wp\/v2\/tags?post=247765"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}