Preliminary Data from FANSS Study Show Potential for Blood-Based Lung Cancer Detection in Non-Smoking Population

FANSS study data presented at ESMO Asia 2025 demonstrate the feasibility of screening Asian women who do not smoke

PALO ALTO, Calif., Dec. 5, 2025 /PRNewswire/ -- DELFI Diagnostics, Inc., developer of accessible blood-based, liquid biopsy tests that deliver a new way to enhance early cancer detection, announced that researchers from NYU Langone Health, in collaboration with DELFI Diagnostics, will present preliminary data from the Female Asian Nonsmoker Screening Study (FANSS) at ESMO Asia 2025 in Singapore on Saturday, December 6. The study examines the feasibility of lung cancer screening in Asian women with no smoking history using low-dose CT (LDCT) combined with a cfDNA fragmentomics blood test.

FANSS is a landmark U.S.-based lung cancer screening program for non-smoking Asian American women. Lung cancer in people who have never smoked is an increasing global concern, yet no formal screening guidelines exist for this group. Asian women with no smoking history appear to be at elevated risk for reasons that remain unclear.

"We enrolled 1,000 participants who underwent baseline LDCT, and 13 were diagnosed with invasive lung adenocarcinoma, a 1.3% detection rate," said Elaine Shum, MD, an oncologist and assistant professor at NYU Grossman School of Medicine, and the study's lead investigator. "This rate is higher than what was observed in heavy smokers in the National Lung Screening Trial."

Genome-wide cfDNA fragmentation features from these samples will contribute to ongoing efforts aimed at developing classifiers for early detection of lung cancer in non-smoking populations.

"These results demonstrate the feasibility of incorporating plasma biomarker analysis into screening studies for high-risk populations who currently lack formal guidelines. We look forward to sharing additional findings as the analysis progresses," said Amoolya Singh, PhD, Chief Technology Officer for DELFI Diagnostics.

The study enrolled women aged 40-74, of Asian descent, with no smoking history (defined as fewer than 100 cigarettes in a lifetime) and no history of lung cancer or cancer treatment within the past five years. Of the 13 lung cancers detected, nine were Stage IA, indicating early-stage disease. Follow-up for 14 additional participants with Lung-RADS 3 or 4 scores is ongoing.

FANSS (ClinicalTrials.gov ID: NCT05164757) is funded by private philanthropy, DELFI Diagnostics, and AstraZeneca Pharmaceuticals LP.

About DELFI Diagnostics
DELFI Diagnostics is developing next-generation, blood-based tests that are accurate, accessible, and deliver a new way to help detect cancer. DELFI tests are built to solve the highest-burden population health issues, including in historically underserved demographics, and have the potential to save lives on a global scale. FirstLook Lung, for individuals eligible for lung cancer screening, is our first laboratory-developed screening test and requires a simple blood draw that can be incorporated with routine blood work. The test is based on fragmentomics, the discovery that cancer cells are more chaotic than normal cells and, when they die, leave behind tell-tale patterns and characteristics of cell-free DNA (cfDNA) fragments in the blood. The DELFI platform applies advanced machine-learning technology to whole-genome sequencing data to assess individuals' cfDNA fragments against populations with and without cancer. FirstLook Lung uses these millions of data points to reliably identify individuals who may have cancer detected through low-dose CT, including early-stage disease, with a negative predictive value of 99.8 percent. This test has not been cleared or approved by the FDA.

SOURCE DELFI Diagnostics