Under the deal, ELITechGroup will provide contract development and manufacturing services for HypoxE IVD Tests designed for the Selectra Pro family of clinical chemistry analysers
ELITechGroup and InfanDx AG have signed a MoU to develop InfanDx’ HypoxE Test. (Credit: Fujikama from Pixabay)
ELITechGroup and InfanDx have signed a memorandum of understanding (MoU) to collaborate on the development and manufacturing of InfanDx’s HypoxE Test.
The test will be a part of ELITechGroup’s family of Selectra Pro clinical chemistry analysers.
Both parties expect to sign a formal partnership agreement once the biomarkers targeted by InfanDx’s HypoxE Test are verified in patients from the recently concluded BANON cohort trial.
This last validation is anticipated by the end of the third quarter of this year.
The HypoxE Test from InfanDx is made for the early diagnosis of Hypoxic-Ischemic Encephalopathy (HIE) in infants which can happen due to low oxygen levels during delivery.
Since mid-2021, the companies have been working together informally to create assay prototypes for various HypoxE potential biomarkers resulting from the AAMBI investigation.
According to a recently signed memorandum of understanding, ELITech and InfanDx will work together on the official IVD development of the HypoxE Test for Selectra Pro systems.
InfanDx will handle the assay design, verification, and validation as well as the application for regulatory approval of CE-IVD-marking.
ELITechGroup will produce prototype batches and the finished product under contract based on InfanDx’s design.
As the legitimate manufacturer, InfanDx will market the goods with its logo via a network of business partners.
To do this, the firms are also talking about a business partnership that would make use of ELITechGroup’s global distribution capabilities in more than 100 nations.
ELITechGroup Clinical Systems vice president Maurice Verdaasdonk said: “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.
“The InfanDx HypoxE Test fits very well into our Selectra Pro family of clinical chemistry analysers as they are designed for testing in laboratories that are close to patients, allowing fast turnaround times for critical tests.”
ELITechGroup has delivered over 15,000 clinical chemistry systems worldwide.