Neonatal Diagnostics

Company Focus

InfanDx focuses on unmet diagnostic needs for acute and critical care conditions affecting newborns. Our in vitro diagnostic (IVD) products in development aim at supporting clinicians in timely and informed treatment decisions ensuring best possible outcomes for the most vulnerable of all patients: the newborn infant.

Hypoxic-Ischemic Encephalopathy (HIE)

With its current lead product in clinical development, the HypoxE® test, the company addresses an unmet diagnostic need in Hypoxic Ischemic Encephalopathy (HIE).

What is HIE?

Hypoxic-lschemic Encephalopathy (HIE) is the brain injury caused by oxygen deprivation to the brain, known as perinatal asphyxia. If the asphyxia lasts too long, brain tissue is destroyed. Hypoxic-Ischemic Encephalopathy due to fetal or neonatal asphyxia is a leading cause of death or severe impairment among infants. Such impairment can include epilepsy, developmental delay, motor impairment, neurodevelopmental delay, and cognitive impairment. Often the severity of impairment cannot be determined until a child is several years old.

How frequent is HIE?

About 2% of newborns in high income countries show clinical and/or biochemical signs of perinatal asphyxia. Of these, about 20-30% 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 20-30 thousand will progress to clinical HIE if not treated appropriately.

Can HIE be treated?

The therapy for HIE that is strongly recommended by guidelines and most frequently used to prevent or alleviate lasting brain damage and impairment in moderate and severe cases of HIE is Therapeutic Hypothermia (TH). With this intervention, the body temperature of the newborns is lowered by 3-4 °C for 72 hours allowing the brain to recover and reduce or prevent lasting brain damage. TH is not without risks and needs to be initiated within 6 hours of birth to be effective. Hence, an early and reliable diagnosis is key in the management of HIE.

What is the Diagnostic Challenge in HIE?

The timely and reliable diagnosis of HIE is challenging: Early signs like low APGAR score or fetal blood pH value are rather unspecific. More reliable diagnostic methods such as aEEG and MRI deliver results too late to support the decision to treat the newborn by TH. This leaves a significant diagnostic gap in the effective clinical management of newborns with asphyxia and HIE.

The InfanDx HypoxE® Test

With the HypoxE®-Test in advanced clinical development, InfanDx aims at closing the diagnostic gap in HIE.

Targeted Intended Use

Performed on a simple blood sample routinely taken at birth, the HypoxE-Test® is designed to provide information on the presence, severity and prognosis of HIE. The test aims at aiding clinicians in the early and reliable diagnosis of HIE and hence, supporting them in the decision on whether and how to treat the affected newborns.

Product Strategy

The HypoxE® Test in development relies on the measurement of a panel of metabolites in blood plasma taken at or shortly after birth that are associated with presence, severity and prognosis of HIE. The biomarker assays are being developed for routinely available clinical chemistry instruments for the lab and the point-of-care by commercial partners. The blood concentrations of the biomarkers together with other clinical data routinely obtained at birth are uploaded into a cloud-based AI-powered clinical Decision Support System that integrates the data into an HIE score that is reported back to the clinician.