New blood test which can detect brain tumours receives FDA ‘Breakthrough Therapy designation’

Following a trial clinical trial run by researchers at Imperial College Healthcare NHS Trust, a simple blood test to detect cancer in brain tumours has been granted Breakthrough Therapy designation by the United States Food & Drug Association (FDA).

The Breakthrough Therapy designation program can help make medications available to the people in the US faster and is only granted after rigorous evaluation to show that it has the potential for more effective diagnosis of life-threatening diseases such as cancer. The designation program approval process also forms part of the validation process for its use globally. This comes after extensive research with UK patients and positions the Trust as a global leader in brain tumour detection. The test is currently undergoing validation to be approved by NICE as a standard treatment for patients on the NHS and is currently available to patients privately.

Researchers at Imperial College Healthcare NHS Trust were funded by Brain Tumour Research to run the first clinical study in Europe which led to the blood test receiving Breakthrough Therapy designation. The trial sought to detect cancer cells in patients with brain tumours through a non-invasive blood test - also known as a liquid biopsy.


The liquid biopsy, which is approved for use in England, was developed by Datar Cancer Genetics and is the first in the world to successfully provide 100% accurate biopsy results with no risk - meaning the procedure can be done safely and with a high degree of accuracy.


Current diagnoses of brain tumours involve a risky brain biopsy which carries a 2% risk of mortality and has been shown to produce inaccurate biopsy results. In some advanced cases brain biopsies are impossible to perform and doctors have to rely on complex surgical procedures to obtain tumour tissue for evaluation. The blood test requires 15 ml blood and is indicated for patients where a brain biopsy, although necessary, cannot be performed or has been unsuccessful.

Consultant neurosurgeon Kevin O’Neill runs the Brain Tumour Research centre of excellence at Imperial College Healthcare NHS Trust and led the trial to evaluate the test: “This new procedure, although at an early stage, shows a promising new method for diagnosing brain tumours. This blood test can detect the cells released in the blood from a brain tumour, which are extremely rare and otherwise hard to detect. It can also enable us to monitor cancer through these tests and adapt treatment accordingly.


“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 during surgery, I find this technology of significant interest. In particular, the ability to provide a diagnosis from a simple blood test where tumours are deemed inoperable or inaccessible will truly address an unmet clinical need.”

Kevin O’Neill and his team will continue their research of non-invasive blood tests for brain tumours, and will also explore its use in other hard to diagnose cancers, such as pancreatic cancer.