Clinical Study

The early stage detection of cancer increases the optimal results of therapies and subsequently the survival rate of cancer patients. However, the early detection of cancer has remained inadequate for two main reasons:

 

- The existing tools and biomarkers lack a high sensitivity and specificity to be an effective diagnostic test in both asymptomatic and symptomatic cases.

 

- The available methods for early screening are often very expensive and require much care and expertise to perform and interpret the results.

 

Several studies have indicated that DNA repair deficiency and accumulation of DNA damage (Genomic Instability) represents a powerful general biomarker for the early detection of cancer. This effects are not only limited to the cancerous cells and local tissues but also reflected in peripheral blood cells of the cancer patients, independent of their cancer type. Taking advantage of the peripheral blood cells as a mirror of changes within the blood of the cancer patients, these cells are providing a source of sensitive biomarker for early detection of all types of cancer.

 

4D Lifetest™

4D Lifetec has developed the algorithmically based, highly standardized assay called 4D Lifetest™ that offers an outstanding performance results of the Single Cell Gel Electrophoresis Assay.

The 4D Lifetest™ has passed successfully the preclinical phase including standardization for several different types of cancer.  4D Lifetest™ documented as a versatile, precise and reproducible assay with a high-throughput capability.

 

Clinical Study - Phase I

4D Lifetest is now ready to market and therefore we started clinical studies of four most common cancer types including; Breast, Lung, Prostate and Colon cancer. In phase one up to 400 symptomatic patients will be tested in different leading cancer centres of Switzerland.

 

Collaborators

For personalised Lung and Brest Cancer Detection - Clinical Study of 4D Lifetest™ LC and BC:

St. Clara Hospital, Basel (Switzerland) under supervision of PD Dr. med. Bettina Wölnerhanssen, Head of St. Clara Research Ltd.

 

For personalised Prostate Cancer Detection - Clinical Study of 4D Lifetest™ PC:

Cantonal Hospital of St. Gallen (Switzerland) under the supervision of PD Dr. med. Daniel Engeler, Assistant Chief Doctor for Urology and Dr. Reinhard Maier, Operational Head of Clinical Trial Unit (CTU, Cantonal Hospital St. Gallen).

 

All our clinical trials are supported by SAKK Bern.

 

This study will allow us to establish criteria needed for future clinical studies on evaluation of 4D Lifetest™ as a universal early detection assay.

 

 

Clinical Trail Labor 126 small