4D Lifetec, a Basel based startup dedicated to enabling early detection of cancers announced that it received a CE-IVD mark for 4D Lifetest Lung Dx and Breast Dx platforms. Both assays are based on a new non-genomic liquid biopsy which has demonstrated an outstanding early detection potential in clinical validation studies.
The patented 4D Lifetest Lung Dx and Breast Dx by 4D Lifetec are designed to evaluate DNA damage levels in peripheral blood mononuclear cells (PBMCs). The assays are based on a newly developed proprietary biomarker and have demonstrated outstanding early detection capabilities in clinical tests with different clinical centres in Europe and the US. Currently, the assays are dedicated as confirmatory tests to contribute to the diagnostic cascade in cancer detection in combination with other diagnostic assays. Both tests show high sensitivity and specificity > 95%.
The company is already providing customers with its diagnostic solution and thus generating sales. Two months after receiving the CE-Certification for the 4D Lifetest Lung Dx for personalised lung cancer diagnostics, the company obtained another CE-IV mark for its second application, 4D Lifetest Breast Dx. The release of this 4D Lifetest Lung Dx and Breast Dx further demonstrates 4D Lifetec’s commitment to creating a breakthrough in early cancer diagnostics.
Commercialization in the US and Europe
Based on the successful certification the company has now started to launch both assays in Europe and to prepare the market entrance to the US with an LDT based concept. First revenues are expected by the end of 2021. The company also plans to obtain a CE mark for its prostate and colon cancer assays within the next months.
(Press release / RAN)
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