London celebrations

London creators of concussion blood test score ‘milestone’ US patent

A clinical trial is underway for a London-made concussion blood test that has just won a patent in the United States, as the local team moves the finger prick test closer to final regulatory and market approval.

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A clinical trial is underway for a London-made concussion blood test that has just won a patent in the United States, as the local team moves the finger prick test closer to final regulatory and market approval.

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Neurolytixs, the London-based company behind the test, is celebrating its latest patent approval as it launches the Ontario phase of its clinical trial in young athletes, said Douglas Fraser, co-founder and developer of the technology.

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“This is a pivotal clinical trial. It will probably last about a year and a half. It was launched in Michigan and we have Ontario sites going live this week,” said Fraser, who is also a critical care pediatrician and scientist at the Lawson Health Research Institute.

“This will be a multi-center, international clinical trial to show that it not only helps diagnose concussion, but also helps understand the recovery process.”

The trial will likely involve more than 600 young athletes, who will provide baseline blood samples at the start of the season and additional samples after suspected concussions.

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The test measures metabolites, the end products of breakdown in the blood, which are linked to concussions.

London researchers began using artificial intelligence to identify metabolite markers of concussions in 2015, Fraser said, and filed their first patent applications on the blood test technology the following year.

The test tracks changes in blood levels of four lipids, all of which decline after a concussion, by comparing blood samples taken from the finger before and after the injury, taken on filter paper and dried.

Currently, a concussion is diagnosed through physical, cognitive, and behavioral observations, subjective measures that rely on the clinical judgment of individual physicians.

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The Neurolytixs blood test can give doctors a quantitative measure of concussion, Fraser said.

The team already has patents for its technology in the European Union, Canada and China, he said, but has spent years working to get one in the United States.

“It’s like an onion when you patent something. You try to put everything in the patent so you don’t miss anything, and the role of patent examiners is to peel back the layers of the onion on all the stuff that they don’t want to give you,” Fraser said. .

“You try to keep the onion big and they try to get it to the core or throw it out completely.”

The patent is a sign that the London-born test is a “market disruptor with global potential” that is gaining traction and recognition, the company’s co-founder said.

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“This US patent is a remarkable milestone that reflects the extraordinary commercialization potential of this innovation,” Adrian Uthay said in a statement.

With the U.S. patent under its belt, the Neurolytixs team is working toward approval by the U.S. Food and Drug Administration, the world’s largest health regulator, Fraser said. FDA approval is a significant achievement because regulators in other countries often follow its lead, he said.

The Neurolytixs test started the pre-submission process with the US regulator in March, Fraser said. Once the results of his youth sport clinical trial are known, likely in late 2023 or early 2024, he can apply for full approval.

The team is preparing another clinical trial for the blood test targeting construction workers, who often suffer concussions on the job. Launching this trial will likely overlap with the study in young athletes, Fraser said.

The concussion blood test may also have military applications and talks are underway to see if a trial in the Canadian military is possible, Fraser said. Concussions in this area are most often caused by pressure waves from explosions, not blunt force beatings sustained in sports or everyday life, he said.

Western University and the Lawson Health Research Institute – the research arm of London Hospitals – hold the patent for the blood test technology which is licensed to Neurolytixs.

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