Datar Cancer Genetics’ TriNetra-Prostate blood test to detect early-stage prostate cancer has received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation, the company announced. The test has previously received CE certification and is already available in Europe as Trublood-Prostate.
“The breakthrough device designation is a recognition of the potential benefits of TriNetra-Prostate in the clinical setting. The test 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 Vineet Datta, the company’s Executive Director.
In the United States, prostate cancer is the third most common type of cancer. Each year, more than 200,000 men are detected with prostate cancer and the disease is associated with more than 32,000 deaths. The test can identify individuals who are more likely to harbor cancer and aids clinical decision making such as the need to undergo a biopsy for confirmatory diagnosis.
According to the company, studies have shown that TriNetra-Prostate can detect early-stage 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. It detects prostate adenocarcinoma specific circulating tumor cells (CTCs) in the blood. The National Institute for Health Care Excellence (NICE) has issued a briefing on the technology, which, as noted, is already approved in Europe.
The Breakthrough Device Designation is granted by the FDA for devices that demonstrate a potential for more effective diagnosis of life-threatening diseases. The program aims to provide patients and healthcare providers with timely access to medical devices.
Datar is a global oncology research and applications company specializing in non-invasive technologies for improved detection, treatment, and management of cancer. The company’s facility is NABL, ISO, CAP, CLIA accredited. Datar is pursuing large clinical studies in the United States to cover multiple cancers where there is a potential of cure with early detection and aims to have multiple test centers globally.
This is the company’s second test that has received the Breakthrough Device Designation from the US FDA.
In November 2021, Datar announced the FDA granted this special designation for its blood test to detect early-stage breast cancer.
That test uses a proprietary technology to detect CTCs specific to breast cancer. Studies have shown that the test can detect even Stage 0 (DCIS) and Stage 1 cancers with high accuracy. The test requires only 5 ml blood and is indicated for asymptomatic women above the age of 40 years with a physician’s prescription. The test is already available in Europe as Trucheck and is CE marked.
Worldwide more than 2.3 million women are detected with breast cancer each year and early detection is considered critical for cure.
“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,” said Datta, at the time.