BioDirection said today that it won an FDA breakthrough device designation for its Tbit point-of-care blood test for concussion diagnosis.
The Boston-based company’s Tbit system is designed to rapidly detect and accurately measure protein biomarkers that are released from the brain following a head trauma.
“We are pleased to receive this FDA designation and believe it is a clear recognition of the potential advantages of the Tbit System over currently available technology. The Tbit System is designed to measure the body’s response to trauma and provide a rapid point-of-care test result in less than 2 minutes from a single drop of blood, while current technology may run 3-4 hours or more and require serum testing in a central laboratory,” exec chair James Wylie said in a press release.
Early diagnosis of a concussion can support more appropriate treatment decisions and reduce unnecessary head CT scans, the company said.
“Blunt trauma injuries that impact the head and brain require the rapid identification of comorbidities to rule out or confirm the potential of intracranial hemorrhage that may require some form of surgical intervention. The Tbit System has the potential to deliver actionable information to the physician where minutes matter. Longer term, our technology has the potential to support a full continuum of care ranging from stratification of injury, prognosis and return to play and activity,” founder & chief tech officer Brian McGlynn said in a prepared statement.
In April 2017, BioDirection said that it raised $2 million in interim financing to support the clinical development of its Tbit system.
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