InfanDx completes enrollment for BANON study evaluating its diagnostic HypoxE-test® for newborn asphyxia
Cologne/Germany, 03 December 2019
InfanDx AG, a diagnostics company specialized in the development of biomarker-based tests, today announced the successful completion of patient enrollment in its clinical BANON study, which evaluates the HypoxE-test®, a novel test based on metabolomic biomarkers for the rapid diagnosis of brain damage in newborns after oxygen deficit during delivery (asphyxia neonatorum). With a total of 554 patients included in the BANON study, the recruitment target of 500 patients was exceeded. All sub-cohorts met their planned recruitment goals. With the completion of patient enrollment, InfanDx has now initiated the quality-controlled data verification (close-out) for all 13 clinical sites in Germany and Turkey.
The BANON study targets newborn infants potentially affected by perinatal asphyxia. Permanent damage caused by asphyxia can be, in part or completely, prevented by therapeutic intervention with hypothermia treatment, but needs to be initiated within 6 hours after birth. With the BANON study, InfanDx aims to validate the first diagnostic test worldwide to reliably identify affected babies right after delivery and within the available 6-hour timeframe for treatment initiation. The HypoxE-test® will enable rapid point-of-care diagnosis directly in the delivery room including in smaller hospitals, and a transfer of affected newborns to hospitals with neonatal intensive care units (NICUs) for timely hypothermia treatment. The German health authority BfArM has confirmed that InfanDx may use the BANON study samples for performance validation, a direct prerequisite for market approval similar to a phase-III-trial for pharmaceutics. The HypoxE-test® consists of a disposable cartridge and a diagnostic instrument. The obtained study samples will serve to further develop and validate this testing system. InfanDx aims to obtain the CE mark for European market access first.
“The completion of patient enrollment in the BANON study is an immensely important milestone for us and even more, for newborns at risk of asphyxia. Our first-of-its-kind biomarker-based test will allow the early and reliable diagnosis of oxygen deficit during birth and subsequent brain damage. Thus, the HypoxE-test® will enable physicians to apply the existing therapy based on a secured diagnosis and early enough to significantly improve the patients’ prospects on life. We are grateful to have such an enthusiastic team of physicians and top advisors from the neonatology field from all over Europe at our side,” InfanDx’ CEO Ron Meyer commented.
“BANON is one of the largest studies in asphyxia. We are now completing analysis of the results and are confident that we can make this promising test available to neonatologist around the world soon, so that infants can rapidly receive a correct diagnosis and timely treatment to prevent many cases of life-long disability. This will close a critical gap in today’s neonatology with truly life-changing effects for both babies and their families,” added Prof. Dr. Dr. Peter Bartmann, recently emeritus Chief Medical Officer of the Children's Hospital at the University Hospital Bonn and member of InfanDx’ scientific advisory board.
Asphyxia frequently leads to encephalopathy(brain injury) with often lifelong severe consequences, such as cerebral palsy (spasticism). Each year, over one million babies worldwide suffer from neurological impairment due to neonatal asphyxia, the largest single perinatal cause for life-long morbidity.
Previous press releases:
InfanDx AG closes 5,3 Mio EUR Financing (04/24/2019)