Health

Neonatal Diagnostics Company InfanDx AG Establishes

Neonatal Diagnostics Company InfanDx AG Establishes
Written by Publishing Team

  • Team of seasoned scientific advisors to further guide InfanDx on diagnostic needs and product concepts in neonatal acute and critical care
  • Inaugural meeting focused on positioning the HypoxE® test in HIE management, US market entry strategy and product pipeline continuation

Cologne, Germany, January 19, 2022 – InfanDx AG (Cologne, Germany), a private diagnostics company focused on the development and commercialization of new diagnostic solutions for the acute and critical care of newborns, today announced the creation of its new Scientific Advisory Board international. This will provide InfanDx with access to unrivaled scientific and clinical expertise in neonatal diagnostics, metabolomics and biostatistics.

  • Teacher. Dr Dr Peter Bartmann, professor emeritus and former head of the neonatology department and current head of the research group for longitudinal studies at the University of Bonn, Germany – Expert in neonatology and early childhood development
  • Teacher. Dr. Manon Benders, Professor of Neonatology and Head of the Department of Woman and Baby Division at Wilhelmina Children’s Hospital, UMC Utrecht, The Netherlands – Expert in Neonatal Neuroimaging
  • Teacher. Dr. Hans-Peter Deigner, Professor at the Institute for Precision Medicine, University of Furtwangen, Germany, and Visiting Researcher at Fraunhofer Gesellschaft, Institute for Cell Therapy and Immunology, Leipzig, Germany – Expert in metabolomics research and biomarker development
  • Teacher. Dr. Axel Franz, Head of the Center for Pediatric Clinical Studies and Chief Physician, University Hospital Tübingen, Germany – Expert in neonatology, pediatrics and special pediatric intensive care medicine
  • Teacher. Dr. Lena Hellström-Westas, Professor of Perinatal Medicine, Department of Women’s and Children’s Health, Uppsala University, Sweden – Expert in Newborn Brain Monitoring
  • Prof. Dr. Matthias Keller, Chief Physician and Medical Director, Dritter Orden Children’s Hospital, Passau, Assistant Professor at the Technical University of Munich, Germany – Expert in paediatrics, neonatology, neurological biomarker research
  • Prof. Dr. Matthias Kohl, Professor and Dean of Precision Medicine Diagnostics Studies, University of Furtwangen, Germany – Expert in Biostatistics and Biomarker Development
  • Professor Neil Marlow, Emeritus Professor of Neonatology at UCL EGA Institute for Women’s Health, London, UK, and Director of MRC-funded EPICure Studies – Expert in neonatal medicine, neuroscience, developmental outcomes and longitudinal assessment in childhood
  • Teacher. Dr. Ola Saugstad, Professor at Oslo University Hospital, Norway, and Assistant Professor of Pediatrics (Neonatology) at Northwestern University, USA – Expert in neonatal medicine, metabolomics of hypoxia and pathophysiology
  • Teacher. Dr. Manu Vatish, Professor of Midwifery, Nuffield Department of Women’s & Reproductive Health, University of Oxford and Clinical Consultant in Midwifery at Oxford University Hospitals NHS Foundation Trust, UK – Research expert in midwifery and the placenta
  • teacher. Dr. Hacer Yapicioglu Yildizdas, Division of Neonatology, Department of Paediatrics, Cukurova University, Adana, Turkey – Neonatal Intensive Care Expert

As a primary objective, the Scientific Advisory Board will provide guidance to the Company on further clinical evaluation of InfanDx’s biomarker panel for hypoxic ischemic encephalopathy (HIE) following perinatal asphyxia, starvation oxygen at the time of birth and the further development of the HypoxE® test detecting these biomarkers in blood samples from newborns. The test is being developed for widely available diagnostic instrument platforms suitable for near-patient testing in laboratories as well as in point-of-care environments, e.g. delivery rooms.

At its recent inaugural meeting, the Scientific Advisory Board unanimously confirmed the high unmet clinical need in the timely diagnostic assessment of neonates at risk for HIE:

“Birth asphyxia represents one of the greatest burdens of mortality and morbidity in newborns worldwide. To prevent death or lifelong sequelae, new sensitive tests are urgently needed. to identify infants at risk soon after birth,” commented Professor Saugstad.

“Blood biomarkers offer the greatest potential for identifying which babies will benefit from treatment and for personalizing HIE treatment in the future,” Professor Marlow added.

“Catching brain damage early is important because of the plasticity of the neonatal brain: if we can predict neurological outcomes early in life and thus initiate adequate treatments to prevent or repair brain damage in time, that is a huge payoff for the rest of life,” Prof Benders explained.

The board also advised the company on the most effective positioning of the HypoxE® test to aid in better management of HIE with the potential to improve outcomes for affected children.

Other topics discussed with the board included a clinical trial strategy to gain US FDA approval and accelerate entry into the strategically important US market, as well as the pipeline of additional products from society in neonatal acute and critical care.

“We are very pleased to welcome these international thought leaders to our Scientific Advisory Board,” said Dr. Achim Plum, CEO of InfanDx. “These senior experts will help us best position our InfanDx HypoxE® test based on evidence to facilitate the rapid and reliable diagnostic assessment of hypoxic-ischemic encephalopathy – a major unmet medical need and a urgent concern of parents and clinicians.”

###

Short CVs of the members of the scientific council

Please visit the InfanDx website at https://www.infandx.com

About InfanDx

InfanDx AG is a privately held company focused on the development and commercialization of novel diagnostic solutions for acute and critical care conditions in neonates.

The company’s 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. EIH following perinatal asphyxia (lack of oxygen during childbirth) can lead to lifelong disabilities. The long-term adverse effects of HIE can be mitigated and even prevented by neuroprotective hypothermic treatment. However, this time-consuming therapy must be initiated within six hours of birth to be effective, requiring appropriate diagnostic methods to reliably and quickly identify affected newborns.

Although standard diagnostic methods cannot provide a conclusive diagnosis of HIE within this time frame, the InfanDx HypoxE-test® rapid test is designed to help clinicians make timely decisions if neonates need a neuroprotective hypothermia therapy.

The company was incorporated in 2010 in Cologne, Germany, and incubated at the Center for Advanced European Studies and Research (Caesar) Life Sciences Incubator in Bonn, Germany, and after the start-up phase successful, was transferred in 2018 to BioCampus Eau de Cologne.

For more information, please visit: http://www.infandx.com/

For more information, please contact:

InfanDx SA
Dr. Achim Plum (CEO)
Phone. : +49 (0) 221 29271401
info@infandx.com

Media contact

campion
Dr. Ludger Wess / Ines-Regina Buth
Managing partners
info@akampion.com
Phone. +49 40 88 16 59 64 /
Phone. +49 30 23 63 27 68

.

About the author

Publishing Team

Leave a Comment