Research & Development
While we are driven by clinical questions rather than specific biomarker classes or technologies, our research in HIE currently focuses on metabolic biomarkers. Metabolites are particular suitable biomarkers to reflect the very dynamic physiological and pathophysiological events around birth. They also can be easily and rapidly measured leveraging existing fully automated in vitro diagnostic (IVD) instrument platforms.
HypoxE® Test Development

Biomarker Discovery and Validation

In the quest for discovering novel biomarkers suitable for the early and reliable diagnosis of HIE, InfanDx focuses on blood-born metabolites. In our biomarker discovery we combined a hypothesis-driven approach using candidate metabolites from pathway analysis and literature with an unbiased large-scale metabolomics discovery using LC-MS technology. Based on this approach, we have identified several candidate biomarkers and biomarker panels that are now further evaluated in dedicated prospectively collected clinical cohorts with several years of follow-up, namely
The final biomarker panel is expected to be defined in Q3-2021, the validation to be completed in Q2-2022.

LC-MS Assay

To establish a reference method for further research, we are in the process of developing a targeted Generation 1 LC-MS Method that will be optimized for the final biomarker panel. It will serve as gold standard for the development of further assays for the clinical routine as well as providing a template for Laboratory-Developed Tests (LDT) to be implemented for early-adopter use at key academic medical centers in Europe and the US from mid-2022 onwards.

Clinical Chemistry Assays

For broad commercialization, InfanDx develops sensitive and quantitative enzymatic assays that are compatible with routine clinical chemistry analyzers present in any diagnostic lab. With strong candidate biomarkers available and the final panel being defined shortly, we have started feasibility studies for the transfer of such assays for laboratory and point-of-care instrument platforms of our preferred industry partners. We expect a CE-marked Generation 2 Clinical Chemistry Assay for the laboratory to reach the market in later 2023, a CE-marked Generation 3 Clinical Chemistry Assay for the point-of-care in late 2024.

Clinical Decision Support System

The InfanDx HypoxE® Test will integrate plasma concentrations of several biomarkers with other clinical parameters routinely assessed at the time of birth to come to a robust HIE score that is easy to interpret by the treating physician. This integration is achieved by a proprietary algorithm embedded in cloud-based clinical Decision Support System  (cDSS). The cDSS is being developed in compliance with all applicable cybersecurity and data protection laws, regulations, and standards for medical device software. An initial validated version for research-use only will be released in mid-2022, an CE-IVD-cleared version by end of 2023 together with the Generation 2 Clinical Chemistry Assay for laboratory use.
Further Products in Development

CompanionDx Hypothermia

Beyond the HypoxE® Test, InfanDx works on CompanionDx Hypothermia, a test to guide hypothermal therapy in HIE patients. Biomarkers for this test are systematically developed in collaboration with Prof. Dr. med. Ursula Felderhoff-Müser and her team at the University Hospital Essen and Prof. Dr. Hans-Peter Deigner and Prof. Dr. Matthias Kohl and their groups at Furtwangen University.

The project is funded by the German Ministry for Research and Education – BMBF (FKZ 13GW0297A).

Further Product Opportunities

In addition, InfanDx is pursuing further product opportunities in neonatal acute and critical care that are in early, conceptional stages.

R&D Pipeline Overview

InfanDx HypoxE® Test

HIE Biomarkers

InfanDx HypoxE® Test

G1 LC-MS Method

InfanDx HypoxE® Test

G2 IVD Assay

InfanDx HypoxE® Test

G3 IVD Assay

InfanDx HypoxE® Test

Clinical Decision
Support System

InfanDx CDx HT Test

HT Biomarkers

InfanDx CDx HT Test



Further Products

In addition, InfanDx is pursuing further product opportunities in neonatal acute and critical care that are in early, conceptional stages.