Rapid test for brain injury gets FDA breakthrough status

Dive Brief:

A rapid test for traumatic brain injuries (TBI) capable of confirming a concussion in less than 90 seconds has received FDA’s breakthrough device status. The designation for BioDirection's test is intended to speed development, assessment and review of a device.
The test, called the Tbit platform, uses a nanotechnology-based sensor to measure protein biomarkers that are released from the brain into the bloodstream immediately after a head trauma. The system includes a small portable analyzer and a single-use disposable cartridge that can detect small amounts of biomarkers in a drop of blood.
A faster diagnosis for brain injury can support the most appropriate treatment decisions and reduce unnecessary head CT scans, the company said.

Dive Insight:

With its rapid, point-of-care test, BioDirection is tapping into a sizable market. In 2013, about 2.8 million emergency department (ED) visits, hospitalizations and deaths related to traumatic brain injury (TBI) occurred in the United States, according to the Centers for Disease Control and Prevention. TBI contributes to about 30% of all deaths resulting from injury.

Falls are the leading cause of traumatic brain injury, followed by impact with an object and motor vehicle crashes. In a troubling trend, the rate of ED visits for sports- and recreation-related injuries with a diagnosis of concussion or TBI, alone or in combination with other injuries, more than doubled in children between 2001 and 2012, CDC said.

Currently, traumatic brain injury is diagnosed through one or more tests that include assessing a person’s ability to speak and open eyes, level of consciousness, memory loss, and movement of arms. Cognition, neuropsychological and imaging tests may also be performed.

New technologies are arriving to expand diagnostic options for TBI. In January, FDA gave marketing authorization to eye-tracking technology sold by Oculogica called EyeBOX that measures cranial nerve function to detect and assess the severity of a potential TBI. Also last month, BrainScope received expanded indications for its portable system that uses an electrode headset to evaluate electrical activity biomarkers in the brain for signs of TBI.

BioDirection said it expects its test initially to be performed in the emergency room and eventually at the point of injury, assuming it receives FDA clearances.

The system has the potential to rule out or confirm intracranial hemorrhage that may require surgery, BioDirection said. Longer term, it may be used in stratification of injury, prognosis, and decisions involving return to play and activity, the Boston-based company said.