InfanDx

InfanDx, founded in 2010, was a privately held diagnostics company that focused on developing and commercializing diagnostic solutions for acute and critical care conditions in newborns. The company was headquartered in Cologne, Germany, with a branch office in Berlin and a subsidiary in Boston, MA, USA. The company's primary mission was to address the unmet medical need for the early detection of brain damage in newborns.

The company's lead product in development was the HypoxE® Test, designed for the early and reliable identification of Hypoxic-Ischemic Encephalopathy (HIE) within the first hours of a newborn's life. HIE is a type of brain damage caused by oxygen deprivation during birth. The condition's detrimental long-term effects can be mitigated by neuroprotective hypothermia treatment, which must be initiated within six hours of birth. The HypoxE® Test was based on metabolomic biomarkers and aimed to support clinicians in making timely decisions about initiating this crucial therapy. The test was being developed in various formats, including a point-of-care version with a disposable cartridge and a diagnostic instrument, as well as for use on existing clinical chemistry analyzers.

InfanDx's strategy involved extensive clinical validation through studies like AAMBI and BANON to ensure the reliability of its biomarker panels. The BANON study, which enrolled over 500 patients across Germany and Turkey, was a significant milestone, providing the necessary data for performance validation required for market approval. The company pursued a partnering-based strategy to leverage existing diagnostic platforms for rapid commercial deployment. A notable collaboration was established with ELITechGroup to develop and manufacture the HypoxE® Test for their Selectra Pro family of clinical chemistry analyzers, aiming for a global distribution network across more than 100 countries.

Over its history, InfanDx raised a total of $14.8M through multiple financing rounds. Key investors included Alluti GmbH, FIL Bros. Capital GmbH, LSI Pre-Seed Fonds GmbH, Bamed MAM Group, and CVG Capital GmbH. However, in March 2023, the company announced a restructuring and discontinued the development of the HIE test to broaden its diagnostics pipeline for child health. Subsequently, the company entered into bankruptcy and liquidation proceedings in May 2024, and is now listed as out of business.

Keywords: neonatal diagnostics, Hypoxic-Ischemic Encephalopathy, HIE test, newborn brain injury, perinatal asphyxia, metabolomic biomarkers, point-of-care testing, clinical chemistry analyzers, neuroprotective hypothermia, diagnostic solutions, child health, pediatric diagnostics, oxygen deprivation, birth complications, AAMBI study, BANON study, ELITechGroup, medical diagnostics, in-vitro diagnostics, neonatal care