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.
InfanDx’ HypoxE® Test is designed for the early detection of Hypoxic-Ischemic Encephalopathy (HIE), a brain damage that may occur in newborns due to lack of oxygen at the time of birth and that can only be successfully treated when detected within the first hours after birth.
The Companies have been collaborating informally since mid-2021 on the development of assay prototypes for numerous HypoxE® candidate biomarkers derived from the AAMBI study, with numerous assays for such biomarkers already established on Selectra Pro Instruments. Under the recent MoU, ELITech and InfanDx will collaborate on the formal IVD development of the HypoxE® Test for Selectra Pro systems. InfanDx will be responsible for assay design, verification and validation, and the submission for regulatory approval of CE-IVD-marking. Based on InfanDx’ design, prototype lots and the final product will be contract-manufactured by ELITechGroup. With InfanDx being the legal manufacturer, the product will be commercialized under InfanDx’ branding through a network of commercial partners. To this end, the parties are also discussing a commercial collaboration leveraging ELITechGroup’s global distribution capabilities in more than 100 countries.
“We are very excited about this collaboration. While clinical chemistry laboratory equipment has been constantly improving over the last decades, there has been very little innovation in the range of tests for such systems,” said Maurice Verdaasdonk, Vice President Clinical Systems of ELITechGroup. “The InfanDx HypoxE Test fits very well into our Selectra Pro family of clinical chemistry analyzers as they are designed for testing in laboratories that are close to patients, allowing fast turnaround times for critical tests.”
“Our partnership with ELITechGroup is a key element in the execution of our strategy to bring innovative diagnostic tests for acute and critical neonatal care conditions to market,” commented Dr. Achim Plum, CEO of InfanDx. “Working with IVD manufactures as partners allows us to have a lean organizational set-up focused on the clinical development of novel tests. In ELITechGroup, we have found an ideal partner that shares our vision and has a complementary strategy of enabling partners in the diagnostic industry with instruments and reagents.”
ELITechGroup has delivered over 15,000 clinical chemistry systems worldwide. ELITechGroup’s family of fully integrated, state-of-the-art Selectra Pro clinical chemistry systems with liquid-stable, ready-to-use reagents is specifically designed for near-patient laboratories. Proximity to the patients enables rapid test results for critical care conditions such as HIE, making the Selectra Pro family ideal for the broad commercialization of InfanDx’ HypoxE® Test.
ELITechGroup is a privately held group of worldwide manufacturers and distributors of in vitro diagnostic equipment and reagents for clinical chemistry, microbiology, molecular diagnostics, hematology, cytology, and sweat test systems. The Company´s mission is to improve patient care by empowering laboratories to do more in less time, with accuracy, to enable rapid and accurate course of treatment for patients.
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 life. 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 therapy must be initiated within six hours after 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 is headquartered in Cologne, Germany, with a branch office in Berlin, Germany, and a wholly owned subsidiary in Boston, MA, USA.
For more information, please visit: http://www.infandx.com/