— Team of seasoned scientific advisors to further guide InfanDx on diagnostic needs and product concepts in neonatal acute and critical care
— Inaugurating meeting focused on positioning of HypoxE® Test in HIE management, US market entry strategy, and further product pipeline
InfanDx AG (Cologne, Germany), a privately-held diagnostics company focusing on the development and commercialization of novel diagnostic solutions for acute and critical care of newborns, today announced the establishment of its newly formed international Scientific Advisory Board. This will provide InfanDx with access to unparalleled scientific and clinical expertise in neonatal diagnostics, metabolomics, and biostatistics.
- Dr. Dr. Peter Bartmann, Emeritus Professor and former Head of the Department of Neonatology and current Head of the Research Group for Longitudinal Studies at University of Bonn, Germany – Expert in neonatology and early child development
- Dr. Manon Benders, Professor of Neonatology and Head of Department of Woman & Baby Division at Wilhelmina Children’s Hospital, UMC Utrecht, The Netherlands – Expert in neonatal neuro-imaging
- Dr. Hans-Peter Deigner, Professor at Institute of Precision Medicine, Furtwangen University, Germany, and Visiting Scientist at Fraunhofer Gesellschaft, Institute for Cell Therapy and Immunology, Leipzig, Germany – Expert in metabolomics research and biomarker development
- Dr. Axel Franz, Head of the Center for Pediatric Clinical Studies and Senior Physician, University Hospital Tuebingen, Germany – Expert in neonatology, pediatrics and special pediatric intensive care medicine
- Dr. Lena Hellström-Westas, Professor of Perinatal Medicine, Department of Women’s and Children’s Health, Uppsala University, Sweden – Expert in newborn brain monitoring
- Dr. Matthias Keller, Chief Physician and Medical Director, Children’s Hospital Dritter Orden, Passau, Adjunct Professor at the Technical University of Munich, Germany – Expert in pediatrics, neonatology, neurological biomarker research
- Dr. Matthias Kohl, Professor and Dean of Studies Precision Medicine Diagnostics, Furtwangen University, Germany – Expert in biostatistics and biomarker development
- Neil Marlow, Emeritus Professor of Neonatology at UCL EGA Institute for Women’s Health, London, United Kingdom, and Director of the MRC-funded EPICure Studies – Expert in neonatal medicine, neuroscience, developmental outcomes and longitudinal assessment during childhood
- Dr. Ola Saugstad, Professor at Oslo University Hospital, Norway, and Adjunct Professor of Pediatrics (Neonatology) at Northwestern University, USA – Expert in neonatal medicine, hypoxia metabolomics and pathophysiology
- Dr. Manu Vatish, Professor of Obstetrics, Nuffield Department of Women’s & Reproductive Health, University of Oxford and Clinical Consultant in Obstetrics at Oxford University Hospitals NHS Foundation Trust, United Kingdom – Expert in obstetrics and placenta research
- Dr. Hacer Yapıcıoğlu Yıldızdaş, Division of Neonatology, Department of Pediatrics, Cukurova University, Adana, Turkey – Expert in neonatal critical care
As its primary objective, the Scientific Advisory Board will provide guidance to the Company on the further clinical assessment of InfanDx’ biomarker panel for Hypoxic Ischemic Encephalopathy (HIE) as a consequence of perinatal asphyxia, the deprivation of oxygen around the time of birth, and the further development the HypoxE® Test detecting such biomarkers in blood samples from newborns. The test is in development for broadly available diagnostic instrument platforms suited for near-patient testing in laboratories as well as point-of-care settings, e.g. delivery rooms.
In its recent inaugurating meeting, the Scientific Advisory Board unanimously confirmed the high unmet clinical need in the timely diagnostic assessment of newborns at risk for HIE:
“Birth asphyxia represents globally one of the biggest mortality and morbidity burdens on newborn infants. To prevent death or life-long sequelae there is an urgent need for new sensitive tests to identify children at risk quickly after birth,” commented Prof. Saugstad.
“Blood-based biomarkers provide the best potential for identifying which babies will benefit from treatment and for personalizing HIE treatment in the future,” added Prof. Marlow.
“It is important to catch brain injury early because of the plasticity of the neonatal brain: If we early in life can predict neurological outcomes and thereby can initiate adequate treatments to prevent or repair brain injury in time, it is an immense gain for the rest of life,” explained Prof. Benders.
The Board further advised the Company on the most effective positioning of the HypoxE® Test to aid in the better management of HIE with the potential to improve outcomes for children affected.
Further topics discussed with the Board included a clinical trial strategy to achieve US-FDA approval and accelerate the entry into the strategically important US market as well as the Company’s further product pipeline in neonatal acute and critical care.
“We are very pleased to welcome these international key opinion leaders to our Scientific Advisory Board,” said Dr. Achim Plum, CEO of InfanDx. “These top-tier experts will support us in the best possible evidence-based positioning of our InfanDx HypoxE® Test to aid in the timely and reliable diagnostic assessment of Hypoxic-Ischemic Encephalopathy – a major unmet medical need and urgent concern of parents and clinicians.”
Short CVs of Scientific Advisory Board Members
Please check InfanDx’ website at https://www.infandx.com
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 burdensome 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 was incorporated in 2010 in Cologne, Germany, and incubated at the Life Science Incubator at the Center of Advanced European Studies and Research (caesar) in Bonn, Germany, and, following the successful start-up phase, in 2018 relocated to BioCampus Cologne.
For more information, please visit: http://www.infandx.com/