EVALUATION OF BIOMARKERS OF TRAUMATIC BRAIN INJURY EXTENSION STUDY

Inclusion Criteria:

- The Subject is at least 18 years of age at screening.

- The Subject has presented to a Health Care Facility (HCF) or Emergency Department (ED)
with a suspected traumatically induced head injury, as a result of insult to the head
from an external force.

- A Glasgow Coma Scale score of 9-15 at the time of Informed Consent.

- The subject is CT-positive for acute intracranial lesion(s) based on the local
neuroradiologist's review of the subject's head CT scan.

- The CT scan and CT report used to determine eligibility must be available.

- The blood sample is collected as close to the time of head injury as possible, but no
later than 12 hours.

- The Subject or their legal representative is willing to undergo the Informed Consent
process prior to enrollment into this study

Exclusion Criteria:

- Participating in an interventional, therapeutic clinical study that may affect the
results of this study (an observational study would be acceptable).

- Time of injury cannot be determined.

- Primary diagnosis of ischemic or hemorrhagic stroke.

- Venipuncture not feasible (i.e., skin integrity compromised at the venipuncture sites,
blood vessel calcification (i.e., IV drug users, advanced atherosclerosis) both upper
limbs missing (congenital or amputee)).

- The subject has a neurodegenerative disease or other neurological disorder including
dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors.

- The subject has a history of neurosurgery within the last 30 days.

- Administration of blood transfusion after head injury and prior to the study blood
draw.

- The subject is a female who is pregnant or lactating.

- The Subject is otherwise determined by the Investigator to be an unsuitable candidate
for participation. If this criterion applies, a reason must be provided