InfanDx AG: Clinical Findings from Prospective AAMBI Study Highlight Need for Better Early Detection of Neonatal Brain Injury

— Scientific poster presented at the 13th International Newborn Brain Conference

— Data demonstrate the importance of novel and reliable diagnostic markers for the early detection of Hypoxic-Ischemic Encephalopathy (HIE) in newborns

InfanDx AG, a privately-held diagnostics company focusing on novel solutions for acute and critical care of newborns, today announced the presentation of a scientific poster on clinical findings of the prospective AAMBI study sponsored by the Company. The poster authored by Prof. Axel Franz (University of Tuebingen, Germany), Prof. Hacer Yapıcıoğlu Yıldızdaş (Cukurova University, Adana, Turkey), Prof. Peter Bartmann (University of Bonn, Germany) and further members of the AAMBI study group was featured yesterday at the 13th International Newborn Brain Conference hosted by the Newborn Brain Society, an  organization focused on advancing newborn brain care through international multidisciplinary collaboration, education, and innovation.

The data highlight the need for novel reliable biomarkers for the early detection of Hypoxic-Ischemic Encephalopathy (HIE), i.e., neural injury caused by oxygen deprivation around the time of birth (perinatal asphyxia).

If not treated within a few hours after birth, HIE – if not fatal – can result in life-long disabilities such as cerebral palsy, cognitive impairment, and epilepsy. The long-term detrimental effects of HIE can be mitigated and even prevented by neuroprotective therapies initiated within the first hours of birth. However, confirming previous studies, the AAMBI data convincingly demonstrate that currently available assessment criteria are not sufficiently reliable for timely identifying babies that may benefit from such neuroprotective interventions.

The AAMBI study was conducted as a prospective observational trial at four neonatal centers in Turkey.

A total of 160 subjects were screened based on routine clinical assessment and currently available standard parameters (APGAR scores, umbilical cord blood pH and base excess/BE), and 155 of these were classified and assigned to three recruitment groups (eligible for therapy, at risk for HIE, control).

The neonatal short-term clinical outcome was determined for 144 surviving children based on further clinical assessment, cerebral MRI and amplitude-integrated EEG (aEEG). The long-term clinical outcome for 129 children available for follow-up was determined based on results of neurological assessment at the age of 22 to 42 months.

When comparing the initial classification at screening with the long-term outcome, the authors concluded that “for all patient groups, clinical assessment and standard parameters (APGAR scores, umbilical cord blood pH and BE) did not enable accurate prediction of 22 to 42 months neurodevelopmental outcome and hence insufficiently indicate the need for neuroprotective therapies.”

“The data underline the importance of novel, fast and reliable tests for the early detection of HIE in newborns,” said Dr. Achim Plum, CEO of InfanDx. “While neuroprotective treatment options are available or in development, a reliable diagnostic test is still missing. Our goal is to support  doctors in timely informed treatment decisions with the overall mission of significantly reducing the number of children affected by life-long impairments caused by HIE.”

Ultimately, the AAMBI study aims at defining a set of metabolomic biomarkers best suited for the early, reliable  identification of infants with HIE that may benefit from neuroprotective interventions. Results of metabolomic biomarker analyses in blood samples taken at birth are currently under investigation. The study was funded by the Life Science Incubator Bonn of the State of North Rhine-Westphalia and the German Federal Ministry of Education and Research (BMBF).

Building on AAMBI and further clinical studies, InfanDx is developing the HypoxE® Test for the detection of early biomarkers for HIE in blood. The test is designed for broadly available diagnostic instrument platforms and therefore well suited for near-patient testing in laboratories as well as point-of-care settings, e.g. delivery rooms.




About InfanDx

InfanDx AG is a privately held company focusing on the development and commercialization of novel diagnostic solutions for acute and critical care conditions in 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. HIE as a consequence of perinatal asphyxia (oxygen deficit during birth) can result in life-long disabilities. The long-term detrimental effects of HIE can be mitigated and even prevented by neuroprotective hypothermia treatment. However, this therapy must be initiated within six hours of birth to be effective, requiring suitable diagnostic methods to reliably and timely identify the affected newborns.

While standard-of-care diagnostic methods cannot deliver a conclusive diagnosis of HIE within this time frame, the rapid InfanDx HypoxE Test® is designed to support clinicians in the timely decision whether newborns require neuroprotective hypothermia treatment.

The Company is headquartered in Cologne, Germany, with a branch office in Berlin, Germany, and a wholly-owned subsidiary in Boston, MA, USA.

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