Key Players in Blood-Based Concussion Testing Market

There is a great need for better tools to diagnose concussion. Currently, there is no single marker or panel of markers in widespread clinical use and diagnosis remains based on clinical judgment. But as evidenced by the recent flurry of publications and commercial partnerships, blood-based concussion testing may soon be a clinical reality, possibly even at the site of injury.

Until recently, many researchers doubted that it would be possible to develop a blood-based test for concussion, given the risk that the blood-brain barrier would prevent movement of candidate markers from the brain to the blood. However, recent research shows that some markers, including metabolites and proteins, are present in the blood. The challenge is that candidate markers are often present only in low concentrations and can be difficult to detect, especially following mild injury.

Metabolomics profiling is a promising new method of diagnosing concussion which may be amenable to point-of-care testing in the near future.

Just as there is a lack of a reliable marker to diagnose concussion, there is also no objective measure to determine recovery and an athlete’s readiness to return to play. However, measuring the blood protein tau just hours after injury may provide objective clinical information to inform decision-making about predicted recovery times and safe return to play, according to a study published online in Neurology on Jan. 6.

Researchers from the National Institute of Nursing Research and Quanterix (Lexington, Mass.) measured tau levels using an ultrasensitive immunoassay after a sports-related concussion in 46 athletes (soccer, football, basketball, hockey, and lacrosse), as well as in 37 teammates without concussions and a group of 21 healthy, non-athletes. The study utilized Simoa, a highly sensitive, fully automated immunoassay platform (Quanterix). The company reports they plan on launching a clinical trial with the National Football League this year. In the meantime, they are working on shrinking the platform to permit sideline testing. Ultimately, they say, the goal is to get the test sensitive enough to have a tau result within 15 minutes of the injury.

A number of other companies are carrying out clinical trials and regulatory submissions for blood-based concussion tests. Such companies include:

Banyan Biomarkers: San Diego-based Banyan Biomarker’s research is focused on ubiquitin C-terminal hydrolase L1, which is found in brain neurons, and glial fibrillary acidic protein (GFAP) found in specialized glial cells in the central nervous system called astrocytes. The company has partnered with several diagnostics firms including Abbott, Philips, BioMérieux, and Quanterix to develop a handheld test for traumatic brain injury. It says that a test based on these proteins could reduce the need for CT scans to evaluate concussion.

Abbott: Abbott says it is currently developing a blood-based concussion test to detect specific proteins associated with brain injury. The test will be available on Abbott’s i-STAT analyzer, a handheld device used by the military to perform a broad range of common blood tests. Initial test development began in 2014 with funding from the U.S. Department of Defense. The test will reportedly first be available in India while U.S. trials are underway.

For further discussion of the state of concussion testing and the studies mentioned above, see the April issue of Laboratory Industry Report.