Circulating biomarker levels for diagnosis and risk-stratification of traumatic brain injury
Inventors
EDMONDS, Donna J. • VAN METER, Timothy E. • Mirshahi, Nazanin
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Assignees
Immunarray Inc • Brainbox Solutions Inc
MemberBrainBox SolutionsBrainBox SolutionsBrainBox Solutions develops AI-enabled, multi-modality diagnostic and prognostic tools for mild traumatic brain injury that integrate blood-based biomarker panels, digital neurocognitive assessments, and point-of-care device technology. The company's platform is validated through large, multi-site clinical trials covering adults, geriatrics, and pediatrics, with an emphasis on evidence-based evaluation, risk stratification, and real-world clinical adoption. Research partnerships, grant funding, and a strong intellectual property portfolio support their objective of providing diagnostic and prognostic solutions for brain injury across diverse care settings and patient populations.
BrainBox Solutions develops AI-enabled, multi-modality diagnostic and prognostic tools for mild traumatic brain injury that integrate blood-based biomarker panels, digital neurocognitive assessments, and point-of-care device technology. The company's platform is validated through large, multi-site clinical trials covering adults, geriatrics, and pediatrics, with an emphasis on evidence-based evaluation, risk stratification, and real-world clinical adoption. Research partnerships, grant funding, and a strong intellectual property portfolio support their objective of providing diagnostic and prognostic solutions for brain injury across diverse care settings and patient populations.
Publication Number
US-11143662-B2
Publication Date
2021-10-12
Expiration Date
Abstract
Methods, compositions and kits useful in the diagnosis, prognosis and/or assessment of brain injuries and risk for brain injuries, such as hemorrhage, are based upon detection of certain biomarkers.
Core Innovation
The invention relates to diagnosing and risk-stratifying a brain injury in a human patient by measuring levels of brain injury biomarker proteins in a biological sample and detecting changes relative to reference levels. The method focuses on measuring Neuron Specific Enolase (NSE) and Synuclein Beta (SNCB) and detecting an increased level of NSE together with a decreased level of SNCB relative to reference levels of NSE and SNCB.
Based on the detected changed biomarker levels, the method administers treatment for a brain injury when an increased level of NSE and a decreased level of SNCB is detected. The approach uses reference levels of NSE and SNCB, including reference levels from a normal subject and/or reference levels obtained from the same subject at an earlier time point, including baseline pre-injury levels.
The disclosure further connects biomarker patterns to patient management and outcomes in brain injury, including progression, prognosis, and trajectory, with associations reported with neuropsychiatric outcomes such as depression and recovery over follow-up up to 6 months post-injury. The disclosed embodiments include classifier algorithms and use cases tied to clinical decision points such as the need for head CT, urgent treatment, release from treatment, return to work/play, and risk stratification including CT-negative and ACRM-negative (“occult”) TBI.
Claims Coverage
The independent claim specifies an NSE/SNCB biomarker measurement method with a specific detection pattern relative to reference levels and an associated treatment decision. Dependent claims add inventive refinements to the definition of brain injury scope and the reference level determination, including normal-subject reference and within-subject prior-time (baseline pre-injury) reference, as well as specified post-injury sampling time windows.
Measuring NSE and SNCB in a biological sample
A method of measuring the levels of biomarker proteins in a biological sample from a human patient that has or is suspected of having a brain injury by measuring levels of Neuron Specific Enolase (NSE) and Synuclein Beta (SNCB).
Detecting changed NSE and SNCB levels relative to reference levels
Detecting a changed level of NSE and a changed level of SNCB relative to reference levels of NSE and SNCB.
Administering treatment based on increased NSE and decreased SNCB
Administering treatment for a brain injury when an increased level of NSE and a decreased level of SNCB is detected.
Defining brain injury categories for applicability
Selecting the brain injury from specified categories including intracranial bleed/hemorrhage subtypes, progression states, and severity levels.
Using normal-subject reference levels for NSE and SNCB
Using reference levels defined by biomarker levels present in a normal subject not having a brain injury.
Using within-subject reference levels from a prior time point
Specifying that the reference levels are obtained from the same subject at an earlier time point.
Using baseline pre-injury reference levels
Defining the reference levels as baseline levels of NSE and SNCB measured prior to a brain injury.
Specifying post-injury time thresholds for sampling
Obtaining the biological sample from the human subject at least one, at least three, or at least six months post-injury (or post suspected injury).
Overall, the claim coverage centers on an NSE/SNCB biomarker pattern where increased NSE together with decreased SNCB, detected relative to defined reference levels, triggers administration of treatment for brain injury. Dependent claims refine (i) which brain injury categories the method addresses, (ii) how reference levels are established (normal-subject vs within-subject prior-time, including baseline pre-injury), and (iii) the timing of obtaining the biological sample after injury.
Stated Advantages
Provides diagnostic and risk-stratification of brain injury using circulating biomarker protein levels.
Enables patient management decisions based on detecting an NSE/SNCB change pattern relative to reference levels.
Supports risk stratification for CT-negative/ACRM-negative (“occult”) TBI as described in the disclosure.
Associates biomarker patterns with prognosis/trajectory including neuropsychiatric outcomes such as depression and recovery up to 6 months post-injury as described in the disclosure.
Documented Applications
Determining the need for head CT in brain injury risk stratification as described in the disclosure.
Guiding urgent treatment decisions in brain injury as described in the disclosure.
Guiding release from treatment in brain injury as described in the disclosure.
Supporting return to work/play decisions in brain injury as described in the disclosure.
Providing prognosis/trajectory including depression and recovery outcomes over follow-up up to 6 months post-injury as described in the disclosure.
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