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BioDirection Announces Results from Pre-Clinical Study of Tbit™ System for Detection of Traumatic Brain Injury

Boston, MA — BioDirection, Inc., a privately held medical device company developing novel and rapid point-of-care products for the objective detection of concussion and other traumatic brain injury (TBI), announced today results from a pre-clinical study show that the company’s Tbit™ System for the detection of TBI is sensitive, provides actionable results in point-of-care settings, and has the potential to reduce the number of unnecessary computerized tomography (CT) scans. The study was recognized with the best overall abstract award in neurotechnology among more than 800 submissions at the International Brain Injury Association’s 12th World Congress on Brain Injury, the world’s largest gathering of clinicians, scientists, and industry representatives focused on brain injury, held March 29 – April 1, 2017 at the Sheraton New Orleans Hotel in New Orleans, Louisiana.

“Early, objective diagnostic testing of patients who have experienced head trauma can support more rapid and appropriate treatment decisions while potentially reducing unnecessary head CT scans,” said Eric Goorno, president and CEO of BioDirection. “The Tbit System allows for testing to be performed at the earliest stages of a concussion using a single drop of blood. The results from this pre-clinical study, coupled with our meeting with the FDA to review our pre-submission package, have positioned us to initiate our formal clinical trials to support FDA clearance.”

The Tbit System is based on a patented nanotechnology biosensor that rapidly detects and accurately measures protein biomarkers released from the brain immediately following a head trauma, including S100 calcium binding protein beta (S100β) and glial fibrillary acidic protein (GFAP). The system includes a disposable cartridge and portable analyzer designed for testing to be performed with a single drop of blood at the earliest stages of a concussion.

The pre-clinical study was designed to evaluate the ability of the Tbit System to screen TBI patients for a CT positive or CT negative test. Frozen plasma samples were collected from a total of 100 patients who had undergone CT scans post hospital admission. The Tbit System demonstrated 100% sensitivity with no false negative results, and a 41% specificity level.

“The Tbit System provides a sensitive and rapid diagnostic platform that enables the detection of biomarkers of TBI at the molecular level,” said Sergey Dryga, PhD, MBA, chief scientific officer of BioDirection. “This pre-clinical study demonstrated the potential to detect any brain injury requiring further assessment, while reducing the number of unnecessary CT scans by over 40%. The Tbit System also has the potential to enable a much broader range of applications by detecting any number of proven biomarkers in a complex biological sample such as whole blood.”