A leap forward in the diagnosis of inaccessible brain tumours

Brain cancer is the 12th most lethal cancer in the world, taking the lives of more than 250,000 adults each year. According to Brain Tumour Research, in England alone, every two hours, someone is diagnosed with a brain tumour, and in the wider UK, there are an estimated 16,000 yearly diagnoses. At present, no blood test is available for diagnosing brain cancers, and doctors have to rely on complex surgical procedures to obtain tumour tissue for evaluation. This, however, is now changing thanks to Datar Cancer Genetics, a world-leading oncology research and applications company specialising in non-invasive cancer detection, diagnosis and management. shorten the diagnostic pathway that would inform surgeons, I find this technology of significant interest.”

Early this year, Datar, which has advanced testing facilities at Surrey Research Park in Guildford, received US Food and Drug Administration (FDA) ‘Breakthrough Device Designation’ for its revolutionary blood test to help in the diagnosis of brain tumours.

The goal of this formal identification is to expedite patient access to certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. With ‘Breakthrough Device Designation’, the development, assessment and review of a device can be accelerated while preserving the statutory standards for premarket approval.

Datar Cancer Genetics’ risk-free and patient-friendly liquid biopsy, dubbed TriNetra-Glio, has been developed to detect the cells released in the blood from the brain tumour, which are extremely rare and notoriously difficult to detect. It is indicated for patients where a brain biopsy, although necessary, cannot be performed or has been unsuccessful due to the location of the tumour or other constraints.

A research team at Imperial College, London, conducted a blinded, prospective study on TriNetra-Glio to evaluate the test, and the results showed that the liquid biopsy detects brain tumours with high accuracy.

Dr O’Neill continues, “In particular, the intended indication to provide a liquid biopsy diagnosis from a simple blood test where tumours are deemed inoperable or inaccessible will truly address an unmet clinical need. I have found this test to be highly sensitive and specific. This breakthrough technology has true diagnostic utility by detecting cells rather than picking up molecular indicators of disease, which, until now, liquid biopsies have been based upon.”

TriNetra-Glio is the third test from Datar Cancer Genetics to have been granted ‘Breakthrough Device Designation’.

It previously secured approval for its tests for early-stage detection of breast and prostate cancers.

The team at Datar believes that relentless research, bold initiatives, sustained commitment and an unapologetic determination to succeed against cancer will help us defeat the disease.

The company’s blood-based cancer management tests are based on unique technologies and hold the promise of major breakthroughs. TriNetra-Glio is expected to have a huge impact on the diagnosis of brain tumours, and Datar’s portfolio of next-generation sequencing-based tests will continue to grow, leading to new, advanced clinical capabilities.

The study was led by Dr Kevin O’Neill, Consultant Neurosurgeon, Chairman of the Brain Tumour Research Campaign and Principal Investigator for the Brain Tumour Research Charity’s Centre of Excellence, who explains, “In my opinion, a non-invasive blood test that detects circulating tumour cells (CTCs) would help to address many of the problems associated with complex brain tumour diagnosis. As a surgeon working on other technologies to define the tumour and functional boundary during surgery to a molecular level of accuracy and to www.surrey-research-park.com https://datarpgx.com