June 2021 - Second CE-IVD mark received: Launch of 4D Lifetest™ Breast Dx
After reporting the CE-IVD mark reception of our 4D Lifetest™ Lung Dx in April we are happy to inform you today that our second application 4D Lifetest™ Breast Dx also received CE-IVD mark now. Both assays are based on a new non-genomic liquid biopsy which has demonstrated an outstanding early detection potential in clinical validation studies.
A new liquid biopsy platform for cancer detection analysing patient derived peripheral blood mononuclear cells (PBMCs)
The 4D Lifetest™ Lung Dx and Breast Dx are designed to evaluate DNA damage levels in peripheral blood mononuclear cells (PBMCs). The assays are based on a new 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%.
Next Steps: Commercialization in the US and Europe
The release of this 4D Lifetest™ Lung Dx and Breast Dx further demonstrates 4D Lifetec’s commitment to create a breakthrough in early cancer diagnostics. 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 a LDT based concept. First revenues are expected by the end of 2021.
The CE-IVD mark on our breast cancer assay is a welcome achieved milestone. Furthermore, it is our goal to CE mark our prostate and colon cancer assays within the next months.