May 2020 - Preliminary Clinical Study Results show Outstanding Sensitivity of 4D Lifetest™ for Lung Cancer Detection

4D Lifetest™ - one of the rare biomarker assays to reach clinical study

We started our first clinical trial in September 2019. The aim of the study is to validate DNA Repair Sensitivity (DRS) as a reliable biomarker for the early detection of various cancers in the blood of cancer patients using our 4D Lifetest™.
Although the investigation of potential biomarkers for cancer detection is a dominant topic in the scientific literature, recently published data show that we are one of only a few biomarker studies that have successfully reached clinical trials (Fig.1 in blue, The Translational Status of Cancer Liquid Biopsies, Sinisa Bratulic et al., Regenerative Engineering and Translational Medicine, Nov 2019)

Fig.1 Cancer biomarker studies reported in PubMed. Grey bars show the percentage of biomarker articles among all journal articles in PubMed. The orange bars show the percentage of PubMed articles on circulating biomarkers (biomarker articles and letters with MeSH terms “blood”, “plasma”, “serum”, “urine”, or “saliva”). Blue bars show the subset of all biomarker articles and letters from trial, multicenter, validation, clinical, or evaluation studies.

4D Lifetest™ standard protocol for the detection of lung cancer successfully validated for clinical diagnostics

Over the past weeks, we have been able to significantly shorten and simplify the standard protocol for the diagnosis of lung cancer with various experiments. This means that the 4D Lifetest™ is now successfully validated as a robust and simple assay for clinical diagnostics. As next steps, the transfer of this standard protocol for the diagnosis of prostate and breast cancer is projected, as well as the automation of the analysis software together with our partner, the Centre for Machine Learning of the University of Lucerne together with Prof. M. Pouly.

Preliminary clinical study results of 4D Lifetest™ on the diagnosis of lung cancer indicate competitive performance compared to Grail and Thrive

When applied to the supernatant of cell culture, 4D Lifetest™ has demonstrated that the DRS biomarker has a discriminative potential of almost 100% between normal and cancer cell lines (A Novel Approach to Increase Robustness, Precision and High-Throughput Capacity of Single Cell Gel Electrophoresis, Juan C. Cassano et al., ALTEX Aug 28, 2019). A clinical evaluation of this assay has now been carried out in blood samples of healthy subjects and lung cancer patients at different stages (n=20, control =10, cases = 10, stage I to IV) together with the St. Clara Hospital, Basel. Preliminary results now strongly indicate the high potential of DRS with an AUC of 0.95, a 92% sensitivity and 85% specificity to become a reliable biomarker for the diagnosis of lung cancer (Fig.2).

Compared to other diagnostic biomarkers for lung cancer, the sensitivity and specificity of 4D Lifetest™ is comparable or better (Fig.3). Even compared to Grail’s and Thrive's two leading liquid biopsy assays, which are currently under development, initial analysis shows that 4D Lifetest™ has a competitive or better performance. This is remarkable, because in contrast to ctDNA methods, 4D Lifetest™ is a robust non- genomic assay that enables high throughput options at comparatively lower costs realized with less than 5% of the investment necessary to develop other biomarkers.

 
Backed up with these very promising results, our team will now validate our test for lung cancer under high throughput conditions and verify the standard protocol for the use of the 4D Lifetest™ with blood of prostate and breast cancer patients as a multi-cancer assay.