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
US-based in vitro diagnostic company Venaxis announced that the Data and Safety Monitoring Board (DSMD) has recommended the continuation of pivotal clinical trial of the APPY1 test, a multiple biomarker-based assay for identifying patients ...
Tags: Appy1 Test, Clinical Trial
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
In vitro diagnostic company Venaxis has filed for CE mark approval of blood-based appendicitis test, APPY1, in Europe. The company expects to receive CE Mark by the end of 2012 and anticipates initiating commercialization in first quarter ...
Tags: appendicitis test, blood based appendicitis test, FDA, Venaxis
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