Datar Cancer Genetics today announced that the US Food and Drug Administration (FDA) has granted ‘Breakthrough Device Designation’ for its blood test to detect early-stage prostate cancer. This is the second test from the Company that has received the Breakthrough Device Designation from the US FDA. Last year, the Company’s early-stage breast cancer detection test became the first such test to receive the Breakthrough Device Designation.
In Europe, prostate cancer is the second most common type of cancer among males with detection of an estimated 500,000 cases and 100,000 deaths in 2022. The test can identify individuals who are more likely to harbour cancer in the prostate and aids clinical decision making such as the need to undergo a biopsy for confirmatory diagnosis.
Studies have shown that the test can detect early-stage prostate cancer with high accuracy (>99%) without any false positives. The test requires 5 ml blood and is indicated for males of age 55-69 years with serum PSA of 3 ng/mL or higher. The test is based on the detection of prostate adenocarcinoma specific Circulating Tumor Cells (CTCs) in the blood.
“The breakthrough device designation is a recognition of the potential benefits of test in the clinical setting as it can help reduce the number of biopsies among individuals with benign conditions of the prostate and it can also improve detection rates among those who do have prostate cancer. With our proprietary CTC-enrichment and detection technology, there is virtually no risk of false positives among individuals who do not have prostate cancer,” said Dr Vineet Datta, Executive Director of the Company. The test has previously received CE certification and is already available in Europe as ‘Trublood-Prostate’. The UK-NICE last year issued a MedTech Innovation Briefing that described the Test as a ‘Game Changer’.
The Breakthrough Device Designation is granted by the FDA for devices that demonstrate a potential for more effective diagnosis of life-threatening diseases such as cancer. The Breakthrough Devices Program intends to provide patients and healthcare providers with timely access to medical devices granted such designation by prioritized review, expedited development and assessment.
