InfanDx AG develops the first point-of-care (POC) diagnostic test to detect perinatal asphyxia (oxygen deficit during birth) and subsequent brain damage to meet a high medical need in pediatrics. A therapy to prevent or limit brain damage in these children is available but needs to be started within 6 hours after birth. In a clinical trial with more than 100 patients, InfanDx has confirmed several proprietary biomarker combinations that will be used to reliably and rapidly diagnose these infants. Sensitivity and specificity reached more than 90%.
A second clinical trial with 550 patients is ongoing, and German regulators (BfArM) have agreed to use these trial samples as a performance validation study to obtain the CE-mark. In parallel, a POC testing instrument is being developed. A similar testing system for early stroke diagnosis is also planned.
InfanDx at a glance:
|Field of Activity
||Diagnosis of perinatal asphyxia and stroke. Further diagnostics on acute brain events in development.|
|Ownership Structure and Financing||Founders & Management: 67%, PSF Fund (LSI, Bonn): 23%, Bamed Mam Group, Arnika Beteiligungen and one HNI: 10% EUR 4.3 mn invested so far, further financing in preparation.|
|Technology||The InfanDx HypoxE-test® is based on biomarkers derived from metabolomics research. The current multivariate test format uses four markers. InfanDx holds four granted patent families in the EU, USA and Canada for diagnostic applications (asphyxia, encephalopathy, brain injury in preterm born babies, adult stroke). One additional patent has been filed for a unique own POC test system.|
|Products/Services||InfanDx HypoxE-test® and InfanDx analyzer (in development)|
|Unique selling point||InfanDx aims to be first mover in the diagnostic field. The company
develops the first test worldwide for the rapid and reliable identification of newborns at risk for brain damage from perinatal asphyxia. This allows for the timely treatment of affected babies, while the unnecessary treatment of healthy infants can be avoided. Established therapy, treatment guidelines and a worldwide incidence of the disease create a unique market pull for this test.
|Date of Incorporation/
Number of Employees
50670 Köln (Cologne)
|Telephone/Telefax||+49 221 30089783
+49 176 30414656 (IR contact)