Emerging Therapies Explained: Blood test for brain tumours

3 min read

We want to keep you updated and informed on the exciting developments happening with diagnosis and treatment of brain tumours. Therefore, to complement the technical Worldwide Research News published each Saturday, this blog series will delve into recent developments and provide a more in-depth explanation of what scientists are trying to achieve and how the research may go on to benefit patients.  

Blood test for glial-based brain tumours has been given FDA breakthrough designation

Datar Cancer Genetics Inc has announced that the US Food and Drug Administration (FDA) has granted ‘Breakthrough Device Designation’ for its ‘TriNetra-Glio’, a blood test to help in the diagnosis of brain tumours. For the news article, click here.

How does the test work?

The blood test works by isolating tumour cells that have ‘broken free’ from the tumour and are circulating in the blood. Pathologists then stain the isolated cells and view them under a microscope to identify the tumour. 

The vast number of different types of cells that circulate in the blood, from immune system cells to oxygen-carrying red blood cells, make finding the odd circulating tumour cell very difficult. The Datar test overcomes this by exposing a 15ml sample of a patient’s blood to a collection of chemicals which kill normal cells but allow tumour cells (which have different properties to healthy cells) to survive. The surviving cells are stained to make them more visible and highlight certain properties, they are then viewed under the microscope to undergo histopathological evaluation – a process that already takes place with tumour biopsies. 

How could the test benefit patients?

The test could be beneficial to patients in a variety of ways. It may help diagnose patients where a brain biopsy or surgical resection of the tumour is not possible due to the location of the tumour, or other limitations that mean surgery isn’t a safe option.

As the test is significantly cheaper than MRI or other scanning options, it could also help with faster diagnosis of brain tumours. For instance, patients who go to the GP with non-specific symptoms like headaches could be offered a blood test to triage them before offering the much more expensive MRI should it be required.  Ideally it could mean fewer patients having health crises before MRI is offered, reducing the number of late diagnoses and improving patient outcomes as a result.

What stage is the research at now?

In January 2023 the blood test was granted ‘Breakthrough Device Designation’ by the FDA, with the goal of speeding up its development, assessment and review. The aim is to get the test to patients and healthcare providers more quickly. 

In order to validate their initial results on the accuracy of the blood test and achieve the FDA designation for glial malignancies, Datar Cancer Genetics collaborated with Dr Nel Syed, scientific lead of the Brain Tumour Centre of Excellence at Imperial College, London, and Dr Giulio Anichini, a Brain Tumour Research funded clinical fellow, worked with brain tumour patients to perform blood tests and complete surgical resections or biopsies of their tumour. The blood samples were sent to Datar for testing and the results compared with histopathological conclusions from the biopsy by the Imperial research team. The test was shown to be extremely accurate and reliable.  

Dr Kevin O'Neill, Consultant Neurosurgeon and Principal Investigator for the Brain Tumour Research Centre of Excellence at Imperial College London, said: “I find this technology of significant interest. 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.”

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