Summary: DELFI Diagnostics’ blood-based Lung test has been clinically validated to enhance early detection of lung cancer, demonstrating high sensitivity and potential to significantly improve screening outcomes.


  1. The FirstLook Lung test achieved 80% sensitivity and a 99.8% negative predictive value, indicating its effectiveness in accurately identifying lung cancer.
  2. Even modest adoption of this test could lead to significant reductions in lung cancer mortality by enabling earlier diagnosis, the company says.
  3. The test uses low-cost whole genome sequencing, making it a practical addition to existing lung cancer screening methods.

DELFI Diagnostics, Inc., a developer of accessible blood-based AI tests for cancer detection, announced the publication of groundbreaking data in the prestigious journal Cancer Discovery from the company’s L101 study, “Clinical validation of a cell-free DNA fragmentome assay for augmentation of lung cancer early detection.” 

DELFI’s Lung Test

The report details the performance and potential of DELFI’s FirstLook Lung test. This milestone study, led by top researchers in the field, marks a significant advancement in aiding blood-based cancer detection.

“To improve lung cancer screening outcomes at scale, a low-cost test with high sensitivity and high NPV is essential,” says L101 principal investigator, Peter J. Mazzone, MD. “The results of the validation show that DELFI’s test meets these criteria, and our models show the potential population health benefits achievable through even modest adoption. We are long overdue in our need to close lung cancer screening’s gaps.”

FirstLook Lung is a validated high-sensitivity test designed to close the persistent gap and shortfall observed in lung cancer screening. Lung cancer claims more lives of both men and women than any other cancer. Yet despite strong evidence from randomized trials that lung cancer screening is highly effective at reducing the burden and harms of this disease, only 5% of those eligible are screened each year according to the American Lung Association. Introducing a high-sensitivity blood-based lung cancer screening test with the validated performance of FirstLook Lung, the study authors project that even modest utilization could translate to thousands of prevented deaths from lung cancer.

Key Findings and Implications

The study, titled “Clinical validation of a cell-free DNA fragmentome assay for augmentation of lung cancer early detection” involved 958 participants, divided into a group for test training, and a separate independent group for test validation. 

The authors detail the genomic elements derived through low-cost whole genome sequencing and show in the independent validation group that both sensitivity and specificity are remarkably consistent across patient subgroups that differ in demographics, comorbidities, and smoking history. They then present the potential population health impact of the test if used to augment lung cancer screening in the United States, showing that even modest utilization would translate into meaningful shifts toward early-stage diagnosis and downstream reductions in lung cancer deaths.

Key findings include:

  1. Sensitivity: 80% in a screening population across stages of disease
  2. Negative Predictive Value (NPV): 99.8%, meaning a test result of “not elevated” equates to a 2 in 1,000 chance someone has lung cancer
  3. Relative Risk: The likelihood of lung cancer found by low dose computed tomography scan is 5.5 times higher for individuals with a FirstLook Lung “elevated” versus “not elevated” result.

“This publication in Cancer Discovery is just our first step toward improving screening rates with a widely accessible test now available as a laboratory-developed test (LDT),” says DELFI Chief Medical Officer Peter B. Bach, MD. “We are making the test available to partners and customers who share our vision and are committed to improving screening rates across populations in need. We remain committed to additional prospective assessment of the test and platform under our breakthrough device designation with the FDA and in our international collaborations.”

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