New clinical utility data showed that offering a blood-based lung cancer test increased screening participation compared with low-dose CT screening alone.
DELFI Diagnostics presented the first clinical utility data for blood-based lung cancer screening at the American Thoracic Society (ATS) 2026 International Conference. The data, featuring the company’s fragmentomics platform, included five presentations focused on screening uptake, real-world implementation, and health equity.
The centerpiece of the program was a late-breaking oral presentation of the L301 FIRSTLUNG Study, a cluster-randomized interventional trial. The study evaluated whether offering a blood-based lung cancer test increases overall screening rates compared to low-dose computed tomography (LDCT) alone.
“The data we’re presenting at ATS represent a turning point for lung cancer screening,” says Susan Tousi, CEO of DELFI Diagnostics, in a release. “For the first time, we have clinical utility evidence showing that a blood-based test can meaningfully move the needle on screening uptake.”
Improving Screening Accessibility
Despite recommendations from the US Preventive Services Task Force for annual screening via LDCT, fewer than one in five eligible individuals in the US are screened each year, making lung cancer the leading cause of cancer death, according to a release from DELFI Diagnostics. The FirstLook Lung test uses AI to analyze patterns of circulating cell-free DNA fragments in the blood to identify individuals at elevated risk.
James Davis, MD, physician and tenured faculty at Duke University and lead investigator of the study, says the trial addressed whether access to a blood test would increase screening rates in primary care practices. “Results from this study were unambiguous,” says Davis in a release.
Implementation and Equity Data
In addition to the clinical utility data, the company presented real-world implementation evidence from healthcare systems currently using the test. Presentations from Allegheny Health Network examined the association between blood-based testing and screening completion.
Another study, led by Dan Raz, MD, of City of Hope, presented data on the feasibility of at-home blood collection for lung cancer screening. This research focused on reaching patients in under-resourced communities to improve early detection access.
The company’s fragmentomics technology has a negative predictive value of 99.8%, according to the release. The test is designed to guide individuals with positive results toward follow-up with guideline-recommended LDCT. While commercially available in the US, the test has not been cleared or approved by the Food and Drug Administration.
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