The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to our CE-certified test TrucheckTM Breast, a blood test for the detection of early-stage breast cancers. Breakthrough Designation is awarded by the US FDA for innovative devices/analyses that have the potential to ensure more effective diagnosis of life-threatening diseases such as cancer. The aim of the programme is to accelerate development, evaluation and review by the FDA.
Studies have shown that TrucheckTM can even detect stage 1 and 2 breast cancers with high accuracy. Early diagnosis brings tremendous benefits for the patient, because the earlier breast cancer is detected, the better the chances of recovery. The test only requires a blood sample of 26 ml and is indicated for asymptomatic women over the age of 40. The early cancer detection method is based on circulating tumour cells (CTCs) and is already available on the market.
Dr Vineet Datta, Executive Director at DCG, states: “We are pleased that the FDA has recognized the potential of our test for the detection of early-stage Breast Cancer. We believe that the test will offer definitive advantages for Breast Cancer screening once it receives marketing authorization from the FDA”.