InfanDx R&D Focus: Perinatal Asphxia and HIE

InfanDx AG focuses on the development and commercialization of diagnostic solutions for newborns. The Company’s proprietary lead product in clinical development is the InfanDx HypoxE-test® designed for the reliable identification of hypoxic-ischemic encephalopathy (HIE) within the first hours of birth.

Clinical Need

Hypoxic ischemic encephalopathy (HIE) is a major cause of neurological disabilities in newborn infants. HIE is caused by perinatal asphyxia, the insufficient supply of oxygen during birth. Asphyxia is responsible for 23% of the annual global neonatal deaths, and results in long term disability in over 400,000 children. HIE is treated most commonly by neuroprotective hypothermal therapy, which reduces cerebral injury and improves neurological outcome. However, to be effective hypothermal therapy must be initiated within six hours of birth, providing a diagnostic challenge to clinicians to make an individualized decision on initiating hypothermal therapy.

Epidemiology

About 2% of newborns in high income countries show clinical and/or biochemical signs of perinatal asphyxia. Of these, about 20% have significant HIE and will progress to develop clinical symptoms. For the EU, with about 5 million deliveries per year, this translates into about 100 thousand cases of perinatal asphyxia of which 20,000 will progress to clinical HIE if not treated appropriately.

InfanDx Solution: The HypoxE-Test®

In the quest for discovering novel biomarkers suitable for the early and reliable diagnosis of HIE, InfanDx focuses blood-born metabolites. In our discovery we combined a hypothesis-driven approach using candidate metabolites from pathway analysis and literature with an unbiased large-scale metabolomics discovery. Using this approach, we have identified several candidate biomarkers and biomarker panels that now further evaluated in dedicated prospectively collected clinical cohorts with several years of follow-up, namely


  • Biomarker Training: AAMBI (https://clinicaltrials.gov/ct2/show/NCT04714502)
  • Biomarker Validation: BANON (https://clinicaltrials.gov/ct2/show/NCT04714775)

Using the biomarker panels resulting from these clinical validations, InfanDx develops IVD tests initially for rapid near-patient laboratory-based testing with short tun-around time and eventually for the point of care.

InfanDX