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 who are at low risk for appendicitis.
The DSMD, which has been created as part of the company’s pivotal clinical trial for the CE Marked APPY1 test, has recommended the continuation of pivotal clinical based on the completion of second and final futility analysis included in the clinical trial design.
The futility analysis of APPY1 test has been performed on the first 1,061 patients to complete the study and Venaxis announced in July 2013 that the study would continue following a previous futility analysis performed on the first 579 patients to complete the study.
A total of 2,000 evaluable patients will be enrolled in the study.
Out of the 2,000 patients, around 1,300 patients have been enrolled currently and the remaining 700 patients are expected to be enrolled by December 2013.
Venaxis president and CEO Steve Lundy noted since initiating patient enrollment in its pivotal study earlier 2013, the company has focused significant effort on meeting its recruitment goals.
"We’ve worked closely with our clinical sites and enhanced our approach along the way, and through those efforts we have been successful in ramping our enrollment rates efficiently.
"Further encouraged by the DSMB’s final recommendation to complete the trial as designed, we continue to anticipate enrollment completion by the end of 2013, and subject to the clinical trial results, file for FDA clearance in the first quarter 2014," Lundy added.