Banyan Biomarkers, Inc. Targets Protein Biomarkers to Detect Mild to Moderate Traumatic Brain Injury
I found this news release of interest.
Banyan Biomarkers, Inc. today announced initiation of a multi-center, clinical feasibility study designed to demonstrate the effectiveness of the Company’s proprietary protein biomarkers, in detecting mild or moderate traumatic brain injury (MTBI). Banyan Biomarkers’ study will test a panel of biomarkers in blood from several hundred MTBI patients. The U.S. Department of Defense is providing funding to the Company to support the study. The results of the MTBI study will be submitted to the FDA in preparation for an Investigational Device Exemption pivotal trial. Ultimately, Banyan Biomarkers’ goal is to receive FDA approval for the Company’s biomarkers to be used as in vitro diagnostic blood tests for detecting mild to moderate brain injury.
The decision to fund the MTBI clinical study is based on positive data from an ongoing interim analysis currently being conducted by Banyan Biomarkers to assess the sensitivity and specificity of biomarkers in detecting and managing severe brain injury. The U.S. Department of Defense also funded Banyan Biomarkers’ severe brain injury study.
Of the 1.5 million traumatic brain injuries sustained annually in the United States, at least 75% are MTBI, also known as concussion. Physicians have difficulty diagnosing concussions since magnetic resolution images (MRI) and computed technology (CT) scans typically do not reveal concussions.
Gary Ascani, President and Chief Executive Officer, Banyan Biomarkers, Inc., commented, “Since there is currently no FDA cleared blood test to detect traumatic brain injury, Banyan is very gratified that the U.S. Department of Defense continues to fund our important work in this area. The military’s need for a rapid diagnostic test for use in accurately evaluating our injured soldiers will also provide an important tool needed by doctors treating civilians in the emergency room.”
Banyan Biomarkers is the leader in developing in vitro diagnostic products to address unmet clinical needs for the detection of traumatic brain injury. The Company is focused on developing a simple point-of-care blood test that will be used by physicians to detect the presence and severity of brain trauma and improve the medical management of head injured patients. Banyan Biomarkers has a licensing agreement with the University of Florida for exclusive global use of technology related to this product. To learn more about Banyan Biomarkers, Inc., visit http://www.banyanbio.com.
It is well recognized that people with cognitive disabilities (including traumatic brain injury) have a shorter work life expectancy and earn less when compared to the normal cohorts. A new study in Brain Injury, May 2013; 27(5):507‑520 studied whether work outcomes of TBI vocational rehabilitation would have a significant impact in returning those with minor to severe traumatic brain injury back to the work force compared with those who receive usual care. The study, conducted by researchers at the University of Nottingham, UK compared work outcomes of TBI‑vocational rehabilitation compared to usual care. 94 participants (40 TBI‑VR) with TBI resulting in hospitalization greater than 48 hours who were working at the time of injury were followed up by postal questionnaire at 3, 6, and 12 months post hospital discharge. At 12 months, 15% more TBI‑VR participants (27% with moderate/severe TBI) were working than usual care controls(27/37, 75% verse 27/45, 60%).
Also of interest was the study’s reference to a systematic review by van Velzen, which estimated that only a mean of 41% of TBI survivors who were working prior to their injury are in work at one and two years post injury. van Velzen JM, van Bennekom CA,Edelaar MJ, Sluiter JK, Frings‑ Dresen MH “Prognostic factors of return to work after acquired brain injury: a systematic review.” Brain Injury, 209; 23:385‑395.
In the May 23, 2013 issue of Brain Injury, David E. Ross, et al. submitted a Letter to the Editor entitled “Brain MRI volumetry in a single patient with mild traumatic brain injury.” The report described the case of a 42 year old man who was in a motor vehicle accident in May 2008, leading to a mild traumatic brain injury and other injuries. His MRI brain data were analyzed with Neuro Quant (a FDA‑approved computer‑automated method for measuring MRI brain volume) and susceptibility‑weighted imaging (SWI) to assess for signs of old bleeding. A volumetric cross‑sectional (one point in time) analysis showed no brain atrophy, consistent with initial CT and MRI scans of the brain. Volumetric longitudinal (2 points in time) analysis show progressive atrophy in several brain regions. Dr. Ross reports that the case demonstrated that in a single patient the principle discovered in multiple previous group studies, namely that longitudinal design is more powerful than the cross‑sectional design for finding atrophy in patients with traumatic brain injury.
The International Brain Injury Association has announced the call for abstracts for the 10th World Congress on Brain Injury, which will take place on March 19-23, 2014 in San Francisco. The call for abstracts is posted on the IBIA website and will be echoed in the next issue of the International Neuro Trauma Letter.
Health Day News recently issued a story on a study published in NeuroRehabilitation in which the author Jhon Alexander Moreno, a neuropsychologist at the University of Miami, analyzed the results of fourteen studies that together included almost fifteen hundred patients, spouses, partners, and people without traumatic brain injury as well as rehabilitation professionals. According to Health Day News, which reported on the study, “the study found that 50% to 60% of people with TBI have sexual difficulties, such as reduced interest in sex, erectile dysfunction, and pain during sex, difficulties in vagina lubrication, difficulties achieving orgasm or staying aroused, and a sense of diminished sex appeal.” Both the research found that partners of those with TBI experience personality and emotional changes, and a modification of family roles that can lead to a crisis…. For the spouse, the survivor becomes a different person, a person they do not recognize as the one they fell in love with in the past. The spouse becomes a caregiver and this imbalance in the relationship directly affects sexual desire.” According to Dr. Moreno, marital separation rates can be as high as 78% among people with traumatic brain injury.”
For more information, click here.
Diffusion Tensor Imaging Detects White Matter Abnormalities and Associated Cognitive Deficits in Chronic Adolescent TBI
Researchers in Australia and Cincinnati utilized diffusion tensor imaging (DTI) to examine the long‑term alterations in white matter microstructure following traumatic brain injury in adolescents. The researchers utilized DTI in this study, noting that rotational and shearing forces associated with traumatic brain injury often result in multi‑focal and diffuse axonal injuries which are not evident on CT scans or conventional T1 or T2 weighted MRI.
The researchers used adolescents between the ages of 12‑17 who had been hospitalized overnight with confirmed TBI. The injury classifications were defined by values of the Glasgow Coma Scale. All participants were at least twelve months post‑injury to ensure that acute recovery was complete. A comparison group of typically‑developing adolescents with no history of TBI or other neurological insults were recruited from the community. Groups were matched by age, gender, and maternal education. Subjects with significant development delay, significant psychiatric or behavioral disturbance prior to injury and extreme vision or hearing impairments were excluded. Study neuropsychological data and MR imaging were acquired in the chronic phase.
Seventeen adolescents with traumatic brain injury and thirteen controls consented and produced usable imaging data. The TBI control group did not differ on measures of general intellectual ability, although there was a trend for poor performance for word reading (Wrat‑4) in the TBI group. Adolescents with TBI had significantly higher behavioral ratings of executive dysfunction.
There were also group differences in DTI variables. Group comparison of the DTI variables identified several regions of elevated axial diffusivity (AD) in the TBI group across white matter. All clusters were lateralized to the right hemisphere. To “more fully understand the genesis of the right lateralized findings, the study examined the pattern of white and gray matter injuries found in the imaging review. Of the eight participants that had identifiable parenchymal damage, each had at least one site of damage in the right hemisphere at either the sub‑acute or late state of TBI.
The researchers also investigated the association between white matter microstructure and neuropsychological performance.
The researchers found that consistent with their hypothesis, regions of elevated white matter diffusivity were found in adolescents with TBI more than twelve months after the initial injury. The finding of increased pain diffusivity in the TBI group was suggestive of demyelination and axonal death that occurs with traumatic brain injury. The increase of axonal diffusivity for adolescents with chronic TBI agrees with cross‑sectional studies of chronic injury that reported increased axial diffusivity in patients compared to controls.
The researchers concluded “this study augments the existing literature of DTI study of TBI by reporting abnormal white matter microstructure determined by DTI matrices as well as their association with cognitive functioning in a cohort of adolescents who sustained mostly complicated mild or minor TBI... This study also presented evidence for the association between the elevated axial diffusivity, and the processing speed and executive function in the TBI group providing a snapshot of white matter track recovery and its relationship with neuropsychological variables in chronic TBI.” Brain Injury, April 2013; 27(4):454-463.
Forensic courtroom doctors hired by the defense to attack the scientific admissibility of diffusion tensor imaging (DTI) often argue that DTI is only acceptable in research and has no clinical use. As such, DTI should not be admitted in civil actions.
A new article in the latest issue of Neurosurgical Focus describes the use of DTI at the Perlman School of Medicine at the University of Pennsylvania who are using DTI to create a “virtual intra operative map and produce 3D images of white matter tracks during the removal of cancerous tissue, or glioma, responsible for motor, visual, and language function.”
Surgery for removal of malignant tissue often compromises healthy tissue. The use of 3D DTI, will allow neurosurgeons to visualize the white matter tracks, thus assisting them in only removing malignant tissue.
This is a very exciting new development with the use of diffusion tensor imaging.
The United States District Court for the Northern District of Illinois-Eastern Division denied defendants’ Rule 702 Daubert motion to strike the testimony of David Gibson, president of Vocational Economics, Inc. The case is Rossi v. Groft, Case No.10 C 50240 (U.S.D.C. ND April 16, 2013).
This case arose out of an incident in which plaintiff, a bank loan officer, sustained serious injuries. Prior to the accident, plaintiff had never made more than $10,000 per year. Plaintiff was 27 years old and had completed two semesters of college at the time of the incident. Plaintiff testified at his deposition that he had not applied for any jobs since the accident because the income he could earn with his limitations would be equivalent to paying child care, and he was looking to re-enter a physical rehabilitation program. At the time of the incident, plaintiff was in the process of applying for a position at the Cook County Sheriff’s Office as a deputy sheriff.
Plaintiff retained expert vocational economist David Gibson to opine as to plaintiff’s loss of earning capacity due to his injuries. Mr. Gibson opined that plaintiff had a loss in lifetime earning capacity in the range of $957,000.
To reach that conclusion, Mr. Gibson compared plaintiff’s pre-injury earning capacity and work life expectancy with his post injury earning capacity and work life expectancy using data from the U.S. Census Bureau’s American Community Survey. Mr. Gibson used a “proxy” upon which he based both his pre and post injury earning opinions.
Defendants moved to bar Mr. Gibson from testifying under Fed. R. Evid. 702. Defendants did not challenge Mr. Gibson’s credentials. The Court found it noteworthy that Mr. Gibson and his colleagues at Vocational Economics had been permitted by Court to testify as experts using work life expectancy tables to determine diminished earning capacity. See Goesel v. Boley Intl. (H.K) Ltd., No. 09 C 4595 2012 WL 5306284 @ *1-2 (N.D. Ill. October 26, 2012); and Thakore v. Universal Mach. Co. of Pottstown, Inc., 670 F. Supp. 2nd 705, 729‑31 (N.D. Ill. 2009). Rather, defendants argued that Mr. Gibson’s use of average age earning progression of the median male with Rossi’s educational level “utilizes certain generalities clearly contradictory to the facts proffered in this case.” Specifically, defendants complained that Mr. Gibson had failed to consider plaintiff’s earning history, his slim prospects of employment with the Cook County Sheriff’s Office, and plaintiff’s home life. Defendants further urged the Court to bar Mr. Gibson asserting that Gibson’s use of “median person” to assess plaintiff’s earning capacity because plaintiff’s income before the accident was substantially below what Mr. Gibson’s chart showed what would be expected of the median person.
The court reviewed Mr. Gibson’s report which laid out why he believed that the median person he hypothesized was a reasonable proxy for plaintiff. In his report, Mr. Gibson explained, “younger workers rarely have earnings that reasonably represent an average life time earning capacity.”
Defendants also attacked Mr. Gibson’s consideration of plaintiff’s application to the sheriff’s office, and provided the court with an affidavit from the deputy director of the Cook County Sheriff’s Office Merit Board showing that plaintiff may not have been hired by the sheriff’s office because of plaintiff’s prior arrest and history of drug use. Mr. Gibson testified, however, that he did premise his analysis on whether plaintiff would have been hired by the sheriff’s office finding that plaintiff’s application supported Mr. Gibson’s belief that plaintiff would have been actively employed or actively seeking employment similar in nature.
The court found that Mr. Gibson’s opinions were based on sufficient facts and data to be admissible provided that plaintiff presented evidence that his earning capacity has been impaired by the injury. Accordingly, defendants’ motion to strike Mr. Gibson’s report and bar his testimony was denied.
I just received the premier issue of “Brain Injury Journey, Hope, Help, Healing", a magazine for the brain injury community published by Lash and Associates Publishing/Training Inc.
According to the mission’s statement, “Brain Injury Journey – Hope, Help, Healing” helps persons with brain injury, families, and providers successfully navigate challenges and live a full and satisfying life. We offer empowering personal stories, interviews with experts, and clinical updates and research findings. Above all, we provide a community to enhance hope and foster healing after brain trauma or disease.
I strongly recommend this journal not only for survivors and family members, but for providers and neuro law attorneys as well.
How can we, as trial attorneys, best understand the trials and tribulations that our clients experience after sustaining a traumatic brain injury than through the life stories of survivors and their families.
Brain Injury Journal will be published six times a year. Subscriptions can be ordered at www.lapublishing.com/brain-injury-magazine.
Last month, the Fourth International Conference on Concussion in Sport issued its consensus statement on concussion in sport. According to the Preamble, this consensus paper is a “revision and update of the recommendations developed following the first (Vienna 2001), second (Prague 2004), and third (Zurich 2008) international consensus conferences on concussion in sports and is based on the deliberations at the Fourth International Conference on Concussion in Sport held in Zurich, November 2012.”
The Statement defines concussion as a “brain injury and is defined as a complex pathophysiological process affecting the brain, induced by biomechanical forces.” It acknowledges that concussion may be caused either by a direct blow to the head, face or neck or elsewhere on the body with an “impulsive” force transmitted to the head. While noting that concussion typically results in a rapid onset of short-lived impairment of neurological function that resolves spontaneously, it acknowledges that symptoms and signs may evolve over a number of minutes to hours. The statement acknowledges that a concussion may or may not involve a loss of consciousness and notes that in some cases “symptoms may be prolonged.”
The Statement indicates that “the application of neuropsychological testing in concussion has been shown to be of clinical value which contributes significant information in concussion evaluation, and that it should be seen as an aid to the clinical decision-making process in conjunction with a range of assessments of different clinical domains and investigational results.
Most importantly, it was unanimously agreed that there should be no return to play by the athlete on the day of concussive injury.
This is an important paper that should be reviewed by all athletes involved in sports as well as coaches, trainers, and physicians.