AspenBio Initiates FDA Clinical Trial
AspenBio Pharma has initiated a clinical trial to support the FDA 510(k) application for the AppyScore human appendicitis blood-based diagnostic test.
Enrollment of the first patients in the independent, blind, multicenter study began earlier, which will include patients from a large children’s hospital. The study is focused on patients arriving at hospital emergency rooms with a primary complaint of abdominal pain. This is further narrowed with criteria related to medical history and duration and location of abdominal pain.
To help insure a successful trial, AspenBio engaged a highly qualified and experienced contract research organization to plan and direct the trials. Key study endpoints in the trial will be AppyScore’s sensitivity, specificity, negative predictive value, positive predictive value and appendicitis prevalence.
In addition to performance results in the clinical trial, AppyScore’s 510(k) clearance process also requires the submission of a non-clinical data package.
Based upon the rate of recent pilot patient enrollments, AspenBio expects the FDA clinical trial to be completed in approximately four to six months and thereupon, the company plans to submit the results to the FDA as part of a final data package.
After the data has been successfully reviewed by the FDA, final steps will include determining the product label claims, which are also subject to FDA approval. The company looks to complete this process and anticipates FDA 510(k) clearance in early 2009.