Intracranial hemorrhage (ICH) in infants with non-specific symptoms is frequently misdiagnosed. Currently, patients are selected for additional testing – such as brain scans – on the basis of clinical judgement alone, which can be difficult because caregivers often do not provide an accurate history of abusive head trauma. The misdiagnosis of these infants can lead to further abuse and associated injuries. Now a biomarker blood test called Biomarkers for Infant Brain Injury Score (BIBIS) can take some of the guesswork out of diagnosing ICH in infants. The BIBIS score is highly sensitive and specific to ICH and significantly improves the accuracy of infant ICH diagnosis. BIBIS enables physicians to rapidly and accurately confirm ICH in suspected cases, allowing them to provide swift and appropriate intervention. BIBIS will also allow physicians to more confidently rule out ICH, avoiding radiation exposure from unnecessary head scans.

Technology Description

BIBIS is a rapid multiplex immunoassay of four blood biomarkers coupled with a multivariate algorithm. The BIBIS assay is performed on a proprietary microporous silicon substrate which enables the rapid multiplex analysis of biomarkers from small volumes of biological samples. The resultant biomarker concentrations are processed using a multivariate algorithm to provide a score that is highly predictive of ICH. BIBIS was prospectively tested on 599 patients and demonstrated 89.3% sensitivity and 48.0% specificity for ICH. This technology uniquely enables rapid, automated multiplex biomarker testing, making it conducive for use in acute care settings where rapid diagnosis is important.

Advantages

  • Improved sensitivity for identifying ICH in infants over clinical judgement alone
  • High negative predictive value provides confidence that ICH diagnosis was not missed
  • Small volume of sample required
  • Fully automated after sample application
  • Rapid results, which facilitates use in acute care settings

Applications

  • Highly predictive diagnostic testing enabled by multiplex biomarker analysis
  • Diagnostic screening (e.g., infections, allergy)
  • Tests that currently require central laboratory facilities – due to complexity or analytical sensitivity – which are beneficial if performed immediately in near patient settings

IP Status

A PCT has been filed.

Stage of Development

Prototype for point-of-care testing is currently in development.