Disruptive performance of
4D Lifetest™ based on a proven concept

Scientific evidence shows that already at an early stage of cancer affection, tumor growth is directly linked with Genomic Instability. Since 1990 until today, more than 3500 articles on Genomic Instability as biomarker in cancer with approximately 3’000 patients blood samples tested were published in peer-reviewed journals. However, the applicability of this method was not reliable and shows only an AUC [1] of 0.75 with high variation. These tests methods are therefore not reliable enough as a biomarker.

 

With the 4D Lifetest™ our start-up has developed an algorithm based, highly standardized and automated assay which offers outstanding performance results. First validation with lab derived cancer tissues shows very reliable AUC values of 0.91. Recent data [2] document 4D Lifetest™ to be versatile, precise and reproducible with a high-throughput capability.

 

4D Lifetest healthy cancer patients

The graph above illustrates the difference of sensitivity and precision between the benchmark system (dotted line) and 4D Lifetest™ (solid line). Other than the benchmark system, 4D Lifetest™ allows to distinguish very clearly between Healthy Patients (green) and Cancer Patients (red).

 

Therefore, 4D Lifetest™ allows to distinguish very clearly between Healthy Patients and Cancer Patients. Clinical Validation with first patients is currently processed together with the Universities of Basel and St. Gallen for Lung Cancer and Prostate Cancer.

To continue the clinical studies and make 4D Lifetest™ ready to market, the main part of the on-going development is dedicated to translate the above mentioned scientifically promising concept into a daily medical diagnostics assay for various cancer types.

Personalized Medicine and Screening applications of
4D Lifetest™

There is a high market potential for 4D Lifetest™ personalized applications and an unmet diagnostic need for easy and cost effective verification testing’s (see graph below). 4D Lifetest™ has the clear potential to become a routine verification biomarker for personalized cancer diagnostics and will add value to patients life expectation. Therefore the market potential is outstanding. E.g. current accessible market potential in Europe only are several million tests per year (e.g. breast cancer diagnostics are at approximately 26 million tests per year).

 

4D Lifetest addes value differenz Cancer Types

The 4D Lifetest™ S (cancer screening) diagnostic device will open a new market and increase the revenues exponentially. 4D Lifetest™ S will be the first Liquid Biopsy to detect cancer in general at a very early stage. This implies less overall costs for the health care system as well as improvement of life for the patients by a decreased mortality rate.

The accessible market potential in Europe for the general cancer screening is a multiple of the market potential described above.

 

[1] Area Under Curve; The AUC is a measure of how well a parameter can distinguish between two diagnostic groups (cancer patient/no cancer patient). A biomarker requires an AUC value of a minimum of 0.8 to be useful for any diagnostic statement.
[2] Submitted article (The Swiss Federal Laboratories for Materials Testing and Research – EMPA, 2019)
4DLifetest Labor 477 small