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25P - Early detection of breast cancer by liquid biopsy exploiting the DNA damage sensitivity (DDS)


06 Oct 2021




Rahel Nussbaumer


Annals of Oncology (2021) 32 (suppl_6): S1345-S1371. 10.1016/annonc/annonc740


R. Nussbaumer1, J. Godau2, R. Zanetti-Dällenbach3, A. Faisst2, O. Schicht2, Z. Barekati2, F. Staedtler2, B. Woelnerhanssen3

Author affiliations

  • 1 University Hospital Basel, Basel/CH
  • 2 4D Lifetec AG, 6330 - Cham/CH
  • 3 St. Claraspital, 4058 - Basel/CH

Abstract 25P


Breast cancer represents the most frequent cancer in women in Europe, with 27.8% of all newly diagnosed cancer per year and accounts for 16.4% of all annual cancer deaths for females. Although the risk for breast cancer increases significantly after the age of 50 years, it can also affect younger women. Mammography and self-palpation are most widely used for breast cancer detection, followed by a biopsy confirmation. Recently, the use of circulating biomarkers driven from liquid biopsy has received tremendous attention. Despite the progress that has been made in the development of diagnostic methods and devices, unfortunately, there are still considerable limitations in terms of sensitivity and the detection of early cancer stages and the techniques are not yet a standard tool in clinical practice. We address this gap by developing a novel cell-based biomarker assay for early cancer detection and started to assess the assay's performance in clinical settings.


In an observational study, ‘Prospective Evaluation of 4D LifetestTM Parameters to Develop a Universal Early Cancer Diagnosis Test', blood samples from 42 participants were collected (45% patients with newly diagnosed, untreated breast cancer and 55% 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. 2019) to determine DNA Damage Sensitivity (DDS).


Evaluation of DDS comparing non-cancer with cancer samples resulted in more than 95% sensitivity at 95% specificity (95% CI: 79.0% to 99.8%) across all stages. The mean DDS for early-stage breast cancer I and II did not differ significantly from late-stage II and IV, suggesting high performance also for early detection.


In summary, we demonstrate the DDS biomarker assay's potential in detecting breast cancer at an early stage with high accuracy in a simple and non-invasive way. These data suggest that the DDS biomarker assay is expected to become a practical method to support clinical diagnostics.

Legal entity responsible for the study

The authors.


4D Lifetec AG.


J. Godau, Z. Barekati: Financial Interests, Institutional, Principal Investigator: 4D Lifetec AG. A. Faisst: Financial Interests, Institutional, Ownership Interest: 4D Lifetec AG. O. Schicht, F. Staedtler: Financial Interests, Institutional, Full or part-time Employment: 4D Lifetec AG. All other authors have declared no conflicts of interest.

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