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German Dx Firm InfanDx Nabs €1M to Develop Neonatal Encephalopathy CDx

NEW YORK – German diagnostics company InfanDx announced on Tuesday it has been awarded a grant for more than €1 million ($1.1 million) to jointly develop a companion diagnostic test to determine whether newborns may benefit from neuroprotective hypothermia treatment.

InfanDx is taking the lead on the project and will be joined by researchers from University Hospital Essen, Clinic for Pediatrics I, and Furtwangen University. Together they will develop a metabolomic-based test leveraging InfanDx's existing test called HypoxE, which is in late-stage development. The new test format will be developed to predict whether a newborn can benefit from therapies using hypothermia to limit or prevent permanent brain damage resulting from oxygen deficit during delivery, or asphyxia neonatorum.

Such a deficit can lead to neonatal encephalopathy. InfanDx said that only about half of infants affected by neonatal encephalopathy benefit from therapy. The test it and its collaborators are developing can differentiate infants who are likely to respond to hypothermia treatment from those who likely won't.

University Hospital Essen researchers will focus on preclinical development while Furtwangen University researchers will provide expertise in metabolomic biomarker identification and validation. InfanDx will use preexisting specimen from clinical research to validate metabolomic results directly in human samples. It will also perform clinical follow-up examinations with previous study participants to evaluate their health status after treatment.

"This funding will allow us to broaden our test portfolio with a companion diagnostic for neuroprotective hypothermia treatment," InfanDx CEO Ron Meyer said in a statement. "The new companion diagnostic, together with the HypoxE test, which aims to reliably identify babies affected by neonatal encephalopathy within the six-hour timeframe for treatment initiation, will enable neonatologists to make better informed treatment decisions."