DELFI Diagnostics Receives New York State Department of Health Clinical Laboratory Permit, Completing Authorization to Serve Health Systems Across All 50 States

NYSDOH approval, widely recognized as the most rigorous state-level clinical laboratory regulatory standard in the U.S., further strengthens DELFI's regulatory pathway toward FDA in vitro diagnostic device approval

PALO ALTO, Calif., May 28, 2026 /PRNewswire/ -- DELFI Diagnostics, Inc., developer of AI-powered, blood-based tests for cancer detection, today announced it has received a Clinical Laboratory Permit and Test Approval letter from the New York State Department of Health (NYSDOH). With this permit, DELFI is now authorized to offer its FirstLook^™ Lung laboratory-developed test (LDT) in New York. The test is now available in all 50 U.S. states.

The NYSDOH is broadly recognized as the most rigorous state-level clinical laboratory regulatory authority in the United States, requiring formal review and approval of LDTs prior to patient offering. Earning this designation reflects the depth of quality and diligence the DELFI team has built across the organization over the past two years.

"This is about access," said Susan Tousi, Chief Executive Officer of DELFI Diagnostics. "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."

For DELFI, the NYSDOH permit completes the company's clinical laboratory credentialing portfolio and represents a compelling proof point on the path toward FDA approval of its in vitro diagnostic (IVD) device for its FirstLook Lung blood-based lung cancer screening test. Achieving this level of regulatory clearance reflects an exceptionally accelerated timeline for a novel medical device and new technology entering one of the country's most demanding regulatory jurisdictions. DELFI holds CLIA certification, CAP accreditation, and ISO 13485 and ISO 27001 certifications, reflecting the company's commitment to quality and data security standards across its laboratory and quality management systems.

FirstLook Lung is designed for individuals eligible for lung cancer screening within the United States Preventive Services Task Force (USPSTF) criteria and offers a convenient first step in early cancer detection when the disease is most treatable.

About DELFI Diagnostics

DELFI Diagnostics is developing next-generation, blood-based tests that are convenient, accessible, and reliable, offering a new way to help detect cancer. DELFI's proprietary technology leverages advanced AI to analyze patterns of circulating cell-free DNA fragments in the blood, an approach known as fragmentomics, to help detect lung cancer with high sensitivity. FirstLook Lung, the first commercially available blood-based screening test for lung cancer in the United States, serves individuals eligible for lung cancer screening through a simple blood draw that integrates with routine blood work. With a negative predictive value of 99.8 percent, the test identifies individuals at elevated risk for lung cancer, including early-stage disease, and guides them toward follow-up with guideline-recommended low-dose CT. Through novel health system partnerships, DELFI is pioneering electronic medical record (EMR) integration that makes blood-based testing available to historically underserved populations. FirstLook Lung has not been cleared or approved by the FDA.

To learn more about DELFI Diagnostics, visit DELFIDiagnostics.com

SOURCE DELFI Diagnostics