October 2019 - 4D Lifetest™ has successfully entered into clinical study
After reaching Proof of Technology in August the 4D Lifetec team is exited to announce the successful reach of the next milestone by entering into the clinical study with the 4D Lifetest™.
Goal of the Clinical Study
“Prospective Evaluation of 4D LifetestTM Parameters to develop a universal Early Cancer Diagnosis Test”
The clinical study has been designed and documented to reach Proof of Concept for lung and prostate cancer first. The preparation of the documents to apply for ethical approval started in March 2019 the final positive decisions from the ethical committees of northern and central Switzerland have been obtained in September 2019. Together with the Clinical Trial Units (CTU) of both centers involved the diagnostic process in the hospitals has been implemented successfully. Related personal of the hospitals was trained intensively. A blood sampling kit has been developed and the logistic processes have been adapted to medical standards.
Based on these preparations, the hospitals have now started sampling 50 blood samples each from patients definitively diagnosed to be affected with lung or prostate cancer. The blood will be prepared inside the CTUs and send to us. From November onwards, blinded groups, comparing affected with healthy individuals, will be diagnosed in our labs in Cham. The results will help us to optimize the diagnostic value of the analysis performed with 4D Lifetest™ and adapt the conditions to the different applications if necessary (see figure below).
As reported the Proof of Technology demonstrated massively improved precision of the system compared to the benchmark methods used so far. The Proof of Concept shall now show that our ultra-high precise 4D Lifetest™ will make it possible to differentiate between healthy people and cancer patients (increased Diagnostic Value) like assumed. The Proof of Concept will result in a clinical standard protocolfor diagnostics establishing 4D Lifetest™ as Diagnostic Liquid Biopsy Assay for cancer detection (lung and prostate first). This important milestone is expected to be reached first quarter of next year and will lead to a massive value increase of our project.
Already at the beginning of the year, our team has started to select clinical partners based on their competences in oncological applications. St. Claraspital in Basel is one of the leading tumor centers in Switzerland with a strong focus on lung and breast cancer. The Kantonsspital St. Gallen has a competence center for prostate cancer and holds the responsibility to run the national biobank program for the documentation of prostate cancer. Both hospitals have a proven track record in carrying out clinical studies and have experienced Clinical Trial Units (CTU). Together with our clinical partners the team has established Trail Master Files for the study and the related Case Report Forms and Patient Information Files. Extensive training programs in both hospitals has been carried out by 4D Lifetec during the last months. More clinical partners have been determined already to extend and internationalize the study as soon as possible. Having successfully reached Proof of Concept the extension of the study will executed immediately.
Starting the clinical study with our 4D Lifetest™ we have now entered into the most exciting and thrilling phase of our project. A successful Proof of Concept will substantially increase the value to our company and can be expected to become the major door opener for further investors and strategic partners.