Marker Diagnostics will begin a study evaluating a saliva-based concussion test in women’s rugby players. The test, which is CE-certified for adult males, continues from research led by Dr Valentina Di Pietro and Professor Tony Belli at the University of Birmingham.
According to the UK-based company, MTx.100 is the world’s first diagnostic test for mild traumatic brain injury. The test measures expression of small non-coding RNA (sncRNA) biomarkers found in saliva to diagnose concussion. From a non-invasive mouth swab, the test will provide important information to healthcare professionals to assist in diagnosis and management of concussion. Analysis, which is conducted at a laboratory using qPCR, is completed within three hours with instant results available after.
The company’s research is based at the University of Birmingham and testing is already underway that involves data collection from professional and community level rugby players.
There have been increasing calls for guidance on concussion protocol in sports, such as football and rugby. Numbers have shown that concussion rates have been at their highest level in professional tournaments since records began.
Marker says it is preparing US Food and Drug Administration (FDA) submissions after it received CE marking.
“It is critical to provide specific and accurate biological concussion diagnosis and safe return to play for women. The test can then be used to objectively support enhanced player welfare practices focused on brain health across at all levels of female sport,” said Marker’s chairman David Cohen.
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“Concussion can be difficult to diagnose, particularly in settings such as grass roots sports where evaluation by a specialist clinician is not possible. Consequently, some concussions may go undiagnosed. A non-invasive and accurate diagnostic test using saliva is a real game changer and will provide an invaluable tool to help doctors diagnose concussions more consistently and accurately,” said Dr Di Pietro.