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In December 2021, RQM+ acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. The integration of this impressive team enhances the extensive RQM+ network of current and former FDA reviewers, scientists, engineers and regulatory and quality experts, and adds additional expertise with FDA submissions. The author of this post is a member of this team, which has done significant work with novel and/or high-risk devices focusing on pre-submissions, 510(k)s, IDEs, PMAs, De Novos, Breakthrough Designation Requests and Safer Technology Program Requests.
Every once in a while, a "breakthrough" medical device promises to address unmet medical needs through its innovative technology. Such devices are reviewed by the FDA under their Breakthrough Devices Program
, which allows for expedited development and release of the devices into the market. One such promising in vitro diagnostic device is for detection of mild traumatic brain injury (mTBI)—commonly known as concussion. The Banyan BTI (Brain Trauma indicator) is a biomarker-based, in vitro diagnostic blood test developed by Banyan Biomarkers, Inc. That's right! A blood test for brain trauma. Truly, we are living in the future.
Traumatic brain injury (TBI) is an injury to the brain following a violent blow to the head. Accidents, sport-related concussions, and falls can all cause TBI. In turn, TBI can be classified as either Mild and Severe. Mild TBI, or mTBI, causes loss of consciousness for less than 30 minutes, resulting in cognitive dysfunctions such as memory loss, attention deficits, and mood swings. It is often missed at the time of initial injury. Severe TBI, on the other hand, causes loss of consciousness for more than 30 minutes. This is due to penetrating skull injury which can result in severe cognitive impairment and even a comatose state for the patient. According to the Centers for Disease Control and Prevention (CDC), in 2013 TBI resulted in approximately 2.5 million emergency visits and 282,000 hospitalizations out of which 94.5 percent of TBIs are mTBIs or concussions.
Banyan BTI detects the presence of two brain-specific biomarkers—UCH-L1 (Ubiquitin Carboxy-terminal Hydrolase-L1) and GFAP (Glial Fibrillary Acidic Protein)—which are quickly released into the blood following a concussion. Measuring these protein levels within 12 hours of a head injury can help identify intracranial lesions following an incident.
The current mode for detecting brain tissue damage is to use a neurological scale, called the 15-point Glasgow Coma Scale, followed by a computed tomography or CT scan of the head. The current methodology is defective in the sense that over 90% of patients with mild TBI have a negative CT scan. Moreover, the CT scan has the disadvantage of considerable radiation exposure to patients. Availability of a blood test for mTBI/concussion will likely reduce the amount of CT scans done—saving essential dollars for our health care system.
According to a multi-center, clinical study of 1,947 individual blood samples from adults with suspected mTBI or concussion, and compared with CT scan results, Banyan BTI was able to predict the presence of intracranial lesions with an accuracy of 97.5 percent. Banyan BTI was cleared by FDA via the de novo pathway, and it promises to be the first objective blood test that will help clinicians rule out the need for unnecessary CT scans in persons with mTBI.
These are exactly the types of breakthrough devices that FDA seeks to get to market: it's less invasive and risky for patients, and provides quick results at a lower cost. What's not to like?
Further Reading:
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