Traumatic brain injury (TBI) is a frightening prospect. What makes the prospect more unnerving is that mild TBI such as concussion can be very difficult to diagnose, meaning that next steps in treatment can be difficult to decide.
One reason for this is that concussion presents symptoms, and can occur, in different people at different times. For some it’s instant and obvious, for others it can take hours or even days. That leaves them susceptible to more severe injuries for longer if the condition remains undiagnosed.
Second-impact syndrome can be one such condition which results in brain swelling after a patient suffers a second concussion. This is a particular danger in the sporting arena. Sports like American football, hockey, rugby or boxing are all extremely high risk for concussion, and subsequently second-impact syndrome too.
So, the emergence of fast acting biological tests to detect TBI is understandably a hotbed of research, investment and technological advancement at the moment. When more widespread these tests promise not only to save multiple lives through taking people out of dangerous situations but will also massively lighten the load on already overworked hospitals.
That’s because it’s estimated that fast acting and effective tests to detect TBI will reduce hospital CT scans (the only current way to diagnose a TBI) by up to a third. This will reduce costs for hospitals, cut wait times and also reduce the amount of exposure patients have to potentially harmful radiation from the scans themselves.
I’ve taken a look at 5 companies that are at various stages of development for their diagnostic tests for TBI, all of whom are conducting really interesting research in the space.
It was sharing an article last week about Swiss company ABCDx that gave me the inspiration to write this article after it prompted a great deal of conversation about the state of the industry at the moment.
Founded in 2014, ABCDx have developed a small point-of-care device which uses a single drop of blood to determine whether or not a patient needs to be assessed with a CT scan in hospital.
The device is ultra lightweight, making it portable and applicable in a range of settings to diagnose mild TBI. The test produces results in less than 30 minutes, and is due to be commercialised in 2019 so worth watching out for then.
Banyan have put together the most advanced test of all these companies, having received FDA approval for their Banyan Brain Trauma Indicator test in 2018.
Their test is designed to be administered within 12 hours after potentially receiving a mTBI with results becoming available within 3-4 hours. Approval for the test was helped by a Pentagon-funded, 2,000 person clinical trial who are interested in utilising the procedure in combat situations.
The approval for Banyan also marked an achievement for the FDA themselves who managed to get the application approved in under 6 months as part of their Breakthrough Devices Program. Hopefully this timescale will help future innovations reach the market more quickly.
Quanterix pride themselves on their revolutionary digital approach to immunoassays, which they claim has delivered roughly a 1000 fold increase in their sensitivity.
Speaking in a recent interview, Quanterix CEO Kevin Hrusovsky mentioned the difficulty of detecting biomarkers like those present in cases of mTBI as they appear in such low concentrations. Typically, blood tests would need millions of molecules to detect said biomarkers whereas the Quanterix solution needs only a single molecule of the necessary protein.
They’ve worked closely with other companies in this list, including Banyan, using their biomarkers to explore other opportunities and possibilities to further mTBI research. In 2017 they announced they’d launched the first comprehensive multiplex panel to test the severity of TBIs.
This is a particularly interesting area of research – this level of insight will allow physicians to be more precise than ever with their treatment plans and importantly enable them to prioritise more high-risk patients whose symptoms perhaps haven’t presented themselves as such.
Quanterix have also announced that they’re working with Abbott and bioMérieux to develop handheld point-of-care tests which could be rolled out worldwide. They promise to be a key figure in the future of TBI research.
Medicortex are a Finnish company dedicated to the diagnosis, treatment and prevention of acute neurodegenerative conditions. Their aim is to be able to identify the effects of an mTBI, to prevent development of conditions such as Parkinson’s, Chronic Traumatic Encephalopathy (CTE) or epilepsy.
They’re also developing a diagnostic kit for TBI, announcing a partnership with Canadian Pro-Lab Diagnostics in May this year. Pro-Lab will be responsible for the handling regulatory issues and registration of the kit for Canada and the UK.
Perhaps most interestingly, the kit will detect Medicortex’s biomarkers in saliva and urine. Making this the only non-invasive solution featured.
Founded in 2010, BioDirection have developed a point-of-care diagnostic platform which measures protein biomarkers present in patients who have sustained a TBI.
Offering a truly point-of-care device, their TBit platform takes a single drop of blood and can deliver objective results in under 90 seconds. The device works through a small portable analyser and single-use disposable cartridge suitable for all settings and environments.
BioDirection haven’t received FDA approved yet and the test is still in development but promises to have a huge impact when it hits the market. It’s possible that this test could see physicians able to make rapid decisions at pitch-side, subsequently deciding whether to send the player back on the field or to hospital.
With Banyan’s test gaining approval this year, the market is due to see an influx of similar tests as these companies (as well as a range of others) introduce their solutions to diagnosing TBI.
When it comes to the future, hopefully the likes of Quanterix will be able to diagnose severity too, helping us edge ever closer in our quest to deliver true precision medicine. Their CEO has already mentioned that they’re considering the development of a handheld device that can assess the severity of an injury at the side line of an American football game.
The future could see biomarkers developed which help us understand the relationship between TBI and longer term, degenerative neurological conditions.
It’s an extremely exciting area that I’m going to enjoy watching closely for future developments.
Do you agree with my choices? Are there any other companies you think deserved a mentioned? Let me know in the comments!
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