FDA Approves Blood Testing Device for Mild Traumatic Brain Injuries

 
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Brain Injury
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brain injury

Mild traumatic brain injuries, or concussions, are common in the personal injury world. They are common injuries in car crashes, falls, and assaults, however, until recently diagnosing a brain injury required patients to undergo exposure to radiation through CT scans. Early last year, the U.S. Food and Drug Administration approved the first blood test to aid in the diagnosis of a concussion. The Banyan Brain Trauma Indicator’s approval is thanks in part to research funded by the U.S. Department of Defense and the U.S. Army.

Known as the Banyan BTI, the test identifies certain predictors in the blood that indicate a patient is suffering from a concussion. Eventually, this could help reduce the need for CT scans after a head injury. The FDA claims this will significantly decrease radiation exposure to patients.

Why is traumatic brain injury research important?

Traumatic brain injuries are extremely common injuries in the United States. They are the result of an injury to the brain caused by external physical force. When external forces are severe enough, they lead to head injuries that disrupt normal brain function and leave a person impaired both cognitively and physically.

In 2013, the Centers for Disease Control and Prevention (CDC) estimated nearly 3 million emergency room visits, hospitalizations or deaths in the U.S. were the result of TBIs. Further, as an isolated injury or in combination with others, traumatic brain injuries are a leading cause of death and disability in the United States. In fact, TBIs account for approximately 30% of injury-related deaths.

What is the Banyan Brain Trauma Indicator?

The  Banyan Brain Trauma Indicator is a laboratory assessment tool that measures concentrations of certain proteins present in high quantities after a brain injury. The Banyan BTI measures the following protein biomarkers:

  • Ubiquitin C-terminal hydrolase-L1 (UCH-L1)
  • Glial fibrillary acidic protein (GFAP)

For best results, a blood sample should be taken within 12 hours of a suspected head injury. The results, along with other available clinical information, aids in the evaluation of patients 18 and older with a suspected traumatic brain injury.

A negative result on an assessment test is highly associated with the absence of an acute intracranial lesion. Still, even with this technology, a CT scan is required for a positive brain injury diagnosis.

U.S. Department of Defense

Currently, the device is not available in hospitals in laboratories. Banyan Biomarkers say the company is dedicating all of its efforts to assisting deployed soldiers. The Banyan BTI allows soldiers who don’t always have immediate access to CT scans.

How are suspected brain injury patients tested now?

Modern medical doctors will diagnose a patient with a concussion or other brain injury after several tests. In fact, doctors use a neurological scale called the  Glasgow Coma Scale . This is usually followed up with a CT scan of the head to detect brain tissue damage or intracranial lesions.  Additionally, doctors review a patient’s medical history and conduct other neurological examinations. However, in some cases, true signs and symptoms of a concussion may not appear for hours—sometimes even days—after the injury.

In many brain injury cases, hospital staff may want to hospitalize a suspected concussed patient overnight for observation. Sometimes, a doctor may agree to allow at-home observation. In these cases, a patient should ensure that someone stays with them for at least 24 hours to ensure symptoms don’t worsen.

Currently, the medical standard for assessing brain injuries includes the following:

  • Neurological exams
  • Cognitive tests
  • Imaging tests

The problem with these tests is that they do not assess for mild traumatic brain injuries. In addition, most patients evaluated for TBIs do not have detectable intracranial lesions after having a CT scan.

Banyan BTI Technology

The Banyan BTI uses biomarkers to test for proteins that are typically present in the blood following a brain injury. This technology fills a much-needed gap in the diagnosis of traumatic brain injuries.

Banya BTI’s technology means that doctors can assess a patient for a brain injury. If the biomarkers are present, then doctors can order a CT scan for the affected patient. However, in the absence of the biomarkers, doctors can avoid exposing patients to unnecessary radiation from neuroimaging.

What are biomarkers?

Biomarkers are measurable characteristics of a biological process. In other words, they are medical signs that are present in a living organism indicative of a disease, infection, environmental exposure or injury. While the technology is still relatively new, the presence of biomarkers has become so commonplace in clinical trials, that in some areas their presence is  accepted  without question. Such is the case for biomarkers that have repeatedly shown to correctly predict relevant clinical outcomes across treatments and populations.

There is a spectrum of diagnostic biomarkers. Biomarkers can be classified as

  • Imaging.  This classification includes scans such as CT, PET scans and MRIs.
  • Molecular. This is a fragment of DNA associated with a certain location within a genome.
  • Biopsy. A liquid biopsy typically uses a biofluid sample, such as blood, cerebrospinal fluid or urine for evaluation.

Examples of biomarkers include the following:

  • Pulse
  • Blood pressure
  • Fever
  • Proteins
  • Enzymes
  • Genes and gene products
  • Serum
  • Hormones
  • Cells

Biomarkers are used to measure the progress of the disease, evaluating effective therapies and as well as determining the chances of disease recurrence.

FDA Approval: Breakthrough Devices Program

As part of its Breakthrough Devices Program, the FDA permitted marketing for the Banyan BTI to for concussion evaluation in February 2018.

According to a press release, the FDA reviewed the Brain Trauma Indicator under the FDA’s  De Novo premarket review pathway. This pathway provides a regulatory path for low to moderate risk devices. In many cases, these devices fill a gap where there no other devices presently serving a need.

FDA Evaluation

The FDA evaluated data from a study of almost 2,000 individual blood samples from adults with a suspected concussion. Agency officials review the product’s performance by comparing blood tests to CT scan results. The Banyan BTI was able to predict the presence of an intracranial lesion on a CT scan 97.5% of the time. Further, it correctly predicted those who did not have intracranial lesions on a CT scan 99.6% of the time. According to the FDA, the findings indicate that BTI can reliably predict the absence of intracranial lesions.

As a result of its findings, the FDA supports the health care professionals can incorporate this tool into the standard of care for patients. Eventually, the device will be able to rule out the need for a CT scan in at least one-third of patients with suspected concussions.

Contact a Brain Injury Attorney

Even the mildest of brain injury can lead to significant short-term injuries and long-term consequences, such as trouble concentrating and memory problems. Contact an experienced brain injury attorney to get honest answers and dedicated advocacy for victims of brain and spinal cord injuries.

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