NEW YORK – German diagnostics company InfanDx is inching closer to debuting its first test to the European clinical market.
The Cologne-based firm is currently finalizing a multimarker panel for diagnosing a condition called hypoxic-ischemic encephalopathy that causes brain damage in newborns, and it plans to introduce an initial version of the assay as a laboratory-developed, mass spectrometry-based test later this year, according to CEO Achim Plum.
"We can share it with early adopters that want to establish a laboratory-developed test in their own labs for these markers," Plum said in an interview. This will give the market its first exposure to InfanDx's test, as well as provide both users, and the company with "greater insight into how it works and what information it delivers," he said.
"Between discovery and validation we don't do a technology switch, because we don't want to take any technology risks, but just focus on the biology," Plum added.
This will lay the ground for the launch of a kitted HIE diagnostic, called the HypoxE Test, which InfanDx aims to submit to European regulators for clearance under the new In Vitro Diagnostic Regulation by the end of 2023, Plum said. The IVDR recently began to apply in Europe, and the system is congested as notified bodies struggle to meet the new workload around submissions. As such, Plum said it is unclear when the test could gain a CE-IVD mark under the new system.
Plum would not disclose the platform InfanDx will use for the IVD version of the HIE test but said it would be a biochemical assay run on an existing clinical chemistry platform sold by a third-party vendor. "It's popular, it's an approved instrument, CE-IVD marked, US Food and Drug Administration approved," said Plum.
He said that InfanDx is developing enzymatic assays for the biomarkers it needs to assay and will move the test to the platform from the mass spectrometry platforms it has used during its marker discovery process.
There is also a point-of-care test in the works, and Plum said that InfanDx has a platform in mind for that test too, but similarly declined to name InfanDx's potential technology partner. He described the approach as miniaturized and reliant on a cartridge with dried reagents. "The methodology is the same, but it takes more effort to develop that," said Plum of the POC version. InfanDx aims to submit a POC test for HIE to European regulators by the end of 2024.
The company is preparing to engage US regulators around a submission of its biochemical assay IVD to the FDA and is working on the clinical protocol for a clinical study of the test. Plum said it was difficult to predict when the assay could reach the US clinical market, but perhaps in 2025.
"It depends on the size of the study, and recruitment could take two years or so," he estimated.
HIE is a type of newborn brain damage caused by oxygen deprivation and limited blood flow. To remedy the condition, clinicians induce hypothermia in infants that experience deprivation, as cooling the newborn in an intensive care unit can slow the metabolism of the baby down so that the brain can recover. InfanDx has been seeking to develop a rapid, metabolomic test that can confirm HIE in newborns, so that they can more quickly be selected for induced hypothermia.
Last year, the company raised €4 million ($4.7 million) in the first tranche of Series A financing to support test development, and in March it raised an additional €2 million in a second tranche of the Series A. "That funding will take us well into next year and cover various milestones, including biomarker validation and having prototypes of various assays," Plum said. InfanDx is mulling an eventual Series B round to support commercialization once it reaches that stage.
InfanDx has also added employees and locations. While headquartered in Cologne, it now has offices in the Prenzlauer Berg district of Berlin, and in December it commenced US operations from its Boston office. According to Plum, InfanDx now has about 16 employees and may grow to 20 by year-end. When he took the helm of the firm in early 2021, it was a virtual format and had a handful of employees.
Contemporaneously with that internal growth, the company has worked to finalize its panel of markers for HIE via two ongoing cohort studies. The first, a prospective study called the Asphyxia Associated Metabolite Biomarker Investigation (AAMBI), involved 144 patients from four Turkish partners, and allowed the company to develop a panel of markers using liquid chromatography-mass spectrometry as a discovery platform.
The second, a validation study called Biomarkers And Neurological Outcome in Neonates 2 (BANON) involved about 550 patients from 13 partner centers in Germany and Turkey, and included a two-year clinical follow-up on patients enrolled in the trial. InfanDx announced the completion of BANON at the recent meeting of the German Society for Neonatology and Pediatric Intensive Medicine, held in Aachen last week.
"These cohorts are unique for their design and size," commented Plum regarding both studies. He said the follow-up data gained from BANON was of significance, as the company and its partners could see how having hypoxia at birth correlated with outcome after two years.
It's unclear if there are any other companies working on molecular tests for hypoxia in newborns. Last year, a research team led by investigators from the Royal College of Surgeons in Ireland published a paper in Frontiers in Molecular Neuroscience that discussed the use of a point-of-care biosensor platform called SmartChip to diagnose hypoxia in newborns by measuring the concentration of purine nucleosides in blood. SmartChip is manufactured by Coventry, UK-based Sarissa Biomedical.
HIE is just the start for InfanDx, though its current and most pressing focus. Plum said that the company by design is focused on neonatal acute and critical care, and that even as its next few years will be focused on getting HypoxE out into the market in its various forms, it is considering other opportunities.
"There are so many opportunities in this one space, and we have a structured process where we look at these opportunities," said Plum. He acknowledged the company has both ideas and a pipeline to realize them but declined to elaborate on any future diagnostic plans beyond HIE.