November 2020 - 4D Lifetec publishes first clinical results at the 39th World Cancer Conference
DNA damage sensitivity (DDS) – An efficient biomarker for early detection of cancer using liquid biopsies
Julia Godau1*, Silvan Vesenbeckh2, Sebastian Ott2, Arne Faisst1, Zeinab Barekati1, Oliver Schicht1, Frank Staedtler1, Bettina Wölnerhanssen3.
14D Lifetec AG, Cham, Switzerland
2Pulmonary Medicine, St. Claraspital, Basel, Switzerland
3St. Clara Research Ltd., Basel, Switzerland
*Email address: Julia.godau@4dlifetec.com
Poor prognosis of lung cancer is attributed to the lack of efficient diagnostic methods for early detection and successful treatment of advanced disease. Early stage tumours are small and difficult to identify in a non-invasive way. In addition, patients with early stages of lung cancer do usually not show symptoms but develop signs with progressing malignancy, resulting in late diagnosis of the cancer. Even where cancer screening methods have evolved, they show current limitations in detection of early cancer stages. We address this gap by developing a new biomarker assay for early cancer detection and started to assess the performance of the assay in clinical practice.
In an observational study 'Prospective Evaluation of 4D LifetestTM Parameters to Develop a Universal Early Cancer Diagnosis Test', blood samples from 39 participants were collected (49% patients with newly diagnosed, untreated lung cancer and 51% non-cancer). The biomarker assay itself is based upon ex vivo UV-B radiation of peripheral blood mononuclear blood cells (PBMCs) combined with high performing single-cell gel electrophoresis (Cassano et al. 2020).
Evaluation of the DNA damage sensitivity (DDS) comparing non-cancer with cancer samples resulted in more than 90% sensitivity at 95% specificity (95% CI: 76.4-99.7%) across all stages. The mean DDS for early stage lung cancer I and II did not differ significantly from late stage II and IV suggesting high performance also for early detection. The assay did not significantly discriminate between NSCLC and SCLC, thus serving as a broad test for lung cancer diagnosis. The application to other cancer types is currently being assessed with the goal to develop a multi-cancer assay.
Here, we demonstrate the potential of the DDS biomarker assay in detecting lung cancer with high accuracy in a simple, non-invasive way. These data suggest that the DDS biomarker assay is expected to become a practical method to support clinical diagnostics.