InfanDx receives U.S. patent for its core technology on diagnosis of neonatal encephalopathy

Cologne/Germany, 09 January 2020

InfanDx AG, a diagnostics company specialized in the development of biomarker-based tests, announced today that it has been granted U.S. Patent 10,514,383 US, titled „Method and use of metabolites for the diagnosis and differentiation of neonatal encephalopathy”. The United States Patent and Trademark Office approved the comprehensive patent, which covers the diagnosis of neonatal encephalopathy using biomarkers, at the end of December 2019. This is the second U.S. patent for the HypoxE-test®, following the patent for the diagnosis of perinatal asphyxia. In the EU, InfanDx had already been awarded patent protection for both indications.

The HypoxE-test® is based on metabolomic biomarkers to rapidly diagnose brain damage, which can result from oxygen deficit during delivery (asphyxia neonatorum). This way, affected newborns can be treated in time with an established therapeutic intervention, hypothermia, which limits or completely prevents permanent damage. However, this treatment has to be initiated within six hours after birth. InfanDx aims to offer the first test worldwide to reliably diagnose affected babies within this time window.

“We are excited that we have now received a particularly clear and broad protection for our novel test also in the U.S. as well. Despite the difficult legal situation for biomarker-based tests following the so-called Prometheus ruling in the U.S., we have managed to obtain two essential patents for our test here. Receiving patent protection in such an important market clearly signals our innovative strength,” said Ron Meyer, CEO of InfanDx.

InfanDx plans to market the test as a user-friendly disposable test cartridge together with a dedicated diagnostic device. This will allow for a rapid and easy diagnosis directly in the delivery room. Of the 125 million newborns worldwide each year, 5 - 10 % are at risk to have suffered perinatal asphyxia.

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Previous press releases:

InfanDx completes enrollment for BANON study evaluating its diagnostic HypoxE-test® for newborn asphyxia (12/03/2019)

InfanDx AG closes 5,3 Mio EUR Financing (04/24/2019)

InfanDx AG and LSI, Bonn, announce start of first clinical study (03/01/2017)

InfanDx AG wins new Investor and prepares for Round B Financing (05/17/2016)

Each newborn baby deserves the best start into the future: Life Science Inkubator, Bonn/Germany, takes on the InfanDx-project to identify oxygen deficiency in newborn infant (01/22/2015)