Traumatic brain injury (TBI) is a frightening prospect. What makes the prospect more unnerving is that mild TBI like concussion can be very difficult to diagnose, meaning that it can be difficult to devise treatment plans for the condition.
One reason for this is that concussion doesn’t always present symptoms instantly; it 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 the patient susceptible to more severe injuries 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 a hotbed of research, investment and technological advancement. When more widespread, these tests will save lives through taking people out of dangerous situations and 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 reduce the amount of exposure patients have to potentially harmful radiation from the scans themselves.
I’ve looked 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 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.
Banyan are the company that have progressed the most in this list, 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. They’re 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 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 one 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 enable them to prioritise more high-risk patients whose symptoms may not have presented quickly.
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 is a Finnish company dedicated to the diagnosis, treatment and prevention of acute neurodegenerative conditions. Their aim is to develop a rapid test for detecting traumatic brain damage.
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 handling regulatory issues and registration of the kit for Canada and the UK.
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. This test could empower physicians 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.
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 sideline 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.
Hopefully this will all combine to cut down on the frequent but preventative injuries we see on our TV screens every week.
2024 has the potential to be a year of growth, building upon existing foundations, and ushering in a new era of IVD. An era of portable diagnostic devices and technological advances.
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In this episode, Jack speaks with two Co-Founders at Centivax about life as successful entrepreneurs, the journey to acquisition, challenges and learnings - and using them to become an industry-defining author. Listen now.