Neonatal Diagnostics Company InfanDx AG Appoints Dr. Gunter Weiss as COO

— Dr. Weiss brings more than 15 years of experience in biomarker and in vitro diagnostics development

— Company launched targeted recruiting campaign for next phase of corporate life cycle

InfanDx AG (Cologne, Germany), a privately held diagnostics company focusing on the development and commercialization of novel diagnostic solutions for newborns, today announced the appointment of Dr. Gunter Weiss as Chief Operating Officer (COO). In this role, Dr. Weiss will be in charge of the further clinical development of InfanDx’ biomarkers for Hypoxic Ischemic Encephalopathy (HIE) and the further development of HypoxE® IVD tests detecting such biomarkers in blood samples from newborns. Such tests will be developed for use on various diagnostic instrument platforms suited for diagnostic laboratories and point-of-care settings, e.g.  delivery rooms.

Dr. Weiss brings to InfanDx more than 15 years of experience in biomarker and IVD development for the European, US and Chinese market. His appointment marks InfanDx’ progression from a largely virtual research set-up to a product development and commercial organization: While InfanDx for the biomarker identification mostly relied on an excellent network of clinical and academic partners including the Center for Pediatric Clinical Studies headed by Prof. Axel Franz at the University Hospital Tuebingen and the research groups of Profs. Hans-Peter Deigner and Matthias Kohl at Furtwangen University, the Company now has started building internal IVD development capability. With the funds from the recent Series A financing, InfanDx has launched a targeted recruiting campaign in the areas of metabolomics, IVD assay development, quality management and laboratory operations. Thereby, the management expects to grow the Company´s team from currently 10 to about 18 to 20 highly qualified professionals by year-end 2021.

“Having worked with Gunter successfully for many years before, I am very pleased that we won him over for InfanDx in this crucial phase of the company’s life cycle,” said Dr. Achim Plum, CEO of InfanDx. “Gunter has a rare profile that combines profound biomarker development expertise with extensive experience in the successful development, validation and regulatory approval of IVD products not just in Europe but also in the US and China.”

“I am very glad to join InfanDx at this exciting time with data from two exceptional prospective clinical cohorts at our fingertips for biomarker identification and validation at the highest level,” commented Dr. Weiss on his start at InfanDx. “We are now in a position to prepare the organization for the systematic development of HypoxE® tests for various partnered IVD instrument platforms tailored to market segments and geographies that are most relevant for HIE.”

Dr. Weiss joins InfanDx from a position as Senior Vice President Product Development at Epigenomics AG (Berlin, Germany), where he headed the development of cancer-related diagnostic IVD products. At Epigenomics, Dr. Weiss was key in turning a research organization into a product development company and managed the projects that led to the world’s first CE-marked and FDA-approved liquid biopsy-based IVD products in colorectal cancer screening. Prior to his career in diagnostics, Dr. Weiss’ academic engagement included research positions at the University of Munich, the Max Planck Institute for Evolutionary Anthropology in Leipzig, and a professorship for bioinformatics at Düsseldorf University. Dr. Weiss holds a diploma in statistics and a Ph.D. in computational biology from the University of Munich.



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 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 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.

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