DELFI Diagnostics, a developer of blood-based AI tests that deliver a new way to enhance cancer detection, has announced the publication of a study examining the potential of its blood-based cancer screening, ‘Clinical validation of a cell-free DNA fragmentome assay for augmentation of lung cancer early detection’.
The article, published in the prestigious journal Cancer Discovery, 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.
FirstLook Lung is the first 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 randomised 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 utilisation could translate to thousands of prevented deaths from lung cancer.
The study 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.
L101 principal investigator, Peter J Mazzone MD, noted that: "To improve lung cancer screening outcomes at scale, a low-cost test with high sensitivity and high NPV is essential. 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."
- Mazzone PJ, Bach PB, Carey J, et al. Clinical validation of a cell-free DNA fragmentome assay for augmentation of lung cancer early detection. Cancer Discov. Published online June 3, 2024. doi:10.1158/2159-8290.CD-24-0519