Venaxis, a US-based in vitro diagnostic firm, has completed the patient enrollment in its pivotal clinical study of the APPY1 test in the US. The APPY1 test, a unique appendicitis test, has projected high sensitivity and negative ...
Tags: Venaxis, APPY1, Steve Lundy, FDA
The European Union has granted CE mark approval to Venaxis's blood-based test which is designed to identify patients at low risk for acute appendicitis. The APPY1 test, which is being initially developed for pediatric, adolescent and ...
Tags: blood based test, acute appendicitis, young adult patients
AspenBio Pharma has submitted its AppyScore blood-based test's pre-investigational device exemption (pre-IDE) to the US Food and Drug Administration (FDA). AppyScore blood-based test is designed to aid physicians in identifying children ...
Tags: pre-investigational device, pre-IDE device, AppyScore blood-based test