Hypoxic ischemic encephalopathy (HIE) is a type of brain dysfunction or brain injury that occurs when the brain is deprived of oxygen during fetal or neonatal stages. Treatment options are typically symptomatic. However, there is a guideline-recommended therapy calling therapeutic hypothermia which allows the infant’s brain time to recover. This can prevent complications such as epilepsy or cognitive impairments. While cooling can be effective, its efficacy depends on early intervention; this therapy must begin within six hours following birth. Of course, this can be difficult, particularly when relying on certain clinical parameters. 

As described in Labiotech, InfanDx AG is currently working to overcome these difficulties through the development of the HypoxE blood test. This blood test will use metabolic biomarkers, validated within the Biomarkers And Neurological Outcomes in Neonates (BANON) study. This study builds upon data from a separate study of 155 infants with hypoxic ischemic encephalopathy which identified certain metabolites linked to this condition. 

The BANON Study

Altogether, 553 infants were enrolled within the BANON study. Some infants had HIE while others did not. The research team sourced blood samples from all infants within the study. To evaluate the infants, the study utilized metabolic biomarker panels and interpretive algorithms which can identify potential short and long-term outcomes based on blood samples. 

The BANON study allowed InfanDx to validate biomarkers associated with HIE. Later, blind evaluations of these metabolic biomarker panels–which combine APGAR scores and the presence of biomarkers–showed a specificity of 93% and sensitivity of 89% when looking at short-term outcomes and a specificity of 93% and sensitivity of 74% in long-term outcomes. Because these panels can produce a result quickly, and can be used as soon as five minutes following birth, they can contribute to faster identification and thus, faster treatment.

Now, InfanDx is working to develop the HypoxE blood test based on the validated biomarkers. Currently, the company has developed prototype assays, but further development is needed before the blood test will be available or ready for use. 

What is Hypoxic Ischemic Encephalopathy (HIE)? 

Also known as intrapartum asphyxia, hypoxic ischemic encephalopathy (HIE) is considered one of the leading causes of death and impairment in infants. As described earlier, HIE results from a lack of oxygen to the brain. This can result from placental abruption, a prolapsed cord, medical negligence, acute maternal hypotension, cardiac complications, injury, and uterine rupture (among others). HIE is most common in full-term infants, though it can occur in premature infants. Some infants may have no long-term effects, others may have mild to moderate effects, and, for some, HIE can be fatal. 

Symptoms and characteristics associated with HIE can include:

• Developmental delays
• Cognitive impairment
• Low or high muscle tone (hypotonia or hypertonia) 
• Epilepsy
• Decreased alertness and activity 
• Breathing difficulties
• Organ dysfunction
• Feeding difficulties
• A weak cry