Science
Clinical Validation & Biomarker Science
The science behind each marker, validation data, and laboratory standards that make this evidence defensible.
CAP Accredited
CLIA Certified
FDA-Cleared Assays
Chain-of-Custody
Biomarker Profiles
Four Markers in Detail
GFAP
Glial Fibrillary Acidic Protein
Astrocyte damage marker released into blood within hours of injury.
FDA-cleared for mild-to-moderate TBI evaluation.
Window
0–24 hours
Half-Life
24–48 hours
NPV
99.6%
NfL
Neurofilament Light Chain
Axonal injury protein that rises days to weeks after injury.
Correlates with chronic impairment and white matter damage.
Window
Days–Months
Half-Life
Weeks
NPV
—
APOE
Apolipoprotein E Genotyping
Genetic test identifying alleles linked to worse TBI recovery.
ε4 carriers have elevated CTE and Alzheimer's risk.
Window
One-time test
Half-Life
—
NPV
—
p-Tau217
Phosphorylated Tau 217
Phosphorylated tau linked to neurofibrillary tangle formation.
Bridges acute injury to long-term neurodegeneration risk.
Window
Weeks–Years
Half-Life
—
NPV
—
FDA Clearance
Platform Clearance
GFAP and UCH-L1 assays are FDA-cleared for evaluating suspected mild TBI in adults. NfL, APOE, and p-Tau217 are run as laboratory-developed tests under CAP/CLIA accreditation.
Negative Predictive Value99.6%
Cleared ForMild-to-Moderate TBI
Additional MarkersNfL, APOE, p-Tau217 via LDTs
Lab StandardCAP / CLIA Accredited
Market Context
An Emerging Category
$1.13B
2024 Market Size
18.5%
CAGR Through 2034
$1.38B
2025 Projection
Request Technical Documentation
Access detailed biomarker specifications, validation data, and platform documentation.
