Tag: Hypoxic-Ischemic Encephalopathy (HIE)
ELITechGroup and InfanDx AG to Collaborate on the Development and Manufacturing of HypoxE® Neonatal Care Test for Clinical Laboratories
— HypoxE® Test allows for the early detection of Hypoxic-Ischemic Encephalopathy (HIE) caused by lack of oxygen during birth
— ELITechGroup to provide contract development and manufacturing services for HypoxE® IVD Tests designed for Selectra Pro family of clinical chemistry analyzers
ELITechGroup and InfanDx AG today announced at the ongoing 2022 AACC Annual Scientific Meeting & Clinical Lab Expo in Chicago, IL, USA, the signing of a Memorandum of Understanding (MoU) to collaborate on the development and manufacturing of InfanDx’ HypoxE® Test for ELITechGroup’s family of Selectra Pro clinical chemistry analyzers. The parties intend to enter into a formal collaboration agreement once the biomarkers targeted by InfanDx’ HypoxE® Test are validated in patients from the recently closed BANON cohort study. This final validation is expected by the end of Q3-2022.
Neonatal Diagnostics Company InfanDx AG Launches US Operations
— Incorporated US subsidiary & hired US VP Operations
— Preparing pre-submission meeting with US-FDA
— Received Notice of Allowance for key patent by USPTO
InfanDx AG, a privately-held diagnostics company focusing on the development and commercialization of novel diagnostic solutions for newborns, today announced that it has set up US operations to gain access to the US market for its HypoxE® Test. The test is designed for the early detection of Hypoxic-Ischemic Encephalopathy (HIE) and is currently in clinical development.