NEW YORK (GenomeWeb) – Germany's InfanDx announced it has received the go-ahead from an ethics committee to proceed with a verification study for its metabolomics-based test for brain damage from perinatal asphyxia, or oxygen deficit during birth.
The study, called the Asphyxia-Associated Metabolite Biomarker Investigation (AAMBI) aims to confirm in humans the presence of metabolite profiles found in animal studies that indicated brain damage from asphyxia.
Over the next six months, the firm said it will take post-natal blood samples from 80 newborns suffering from moderate to severe neonatal encephalopathy, as well as healthy controls.
The test could help to quickly diagnose newborns suffering from asphyxia that occurs before, during, or after birth. Earlier diagnosis could push babies towards therapies such as induced hypothermia that must start within six hours after birth.
"This ethics vote and our existing partner clinics featuring sufficient annual case numbers now enable us to take this most meaningful step in our recent company history," InfanDx CEO Ron Meyer said in a statement.