December 28, 2007 - AspenBio Pharma Inc. has outlined plans in 2008 for submitting its final data package to the FDA for market approval of AppyScore, the first blood-based screen/triage test for human appendicitis.
Following its official pre-IDE response from FDA in November, AspenBio plans to complete the final data package for a 510(k) submission by mid to late 2008. FDA regulations require the FDA to complete the 510(k) review within 90 days of submission.
Steps currently proceeding under supervision of the company’s FDA consultants cover the following primary areas: Pivotal clinical data trial definition and completion under FDA regulatory guidelines using GMP validated test version; finalization of logistics with cGMP manufacturer of the AppyScore test; and preparation of FDA 510(k) final data submission package for clearance by FDA.
In order to receive FDA 510(k) clearance, AspenBio must successfully demonstrate the performance characteristics of its final GMP-validated device. This includes nonclinical laboratory performance testing, like assay precision and analytical sensitivity, as well as clinical testing in the field.
AspenBio’s pre-FDA multi-hospital study substantially advanced the optimization of sampling and testing methodologies necessary for FDA clinical studies, the company said. AspenBio and its FDA advisors are finalizing the clinical protocol that will involve testing of about 500 patients in multiple hospital sites.
Based upon AspenBio’s prior experience with patient recruitment rates in the pre-FDA preliminary studies, the company expects this final FDA clinical study to be completed within five to six months. The clinical portion of the 510(k) application will be conducted concurrently in accordance with FDA guidelines and as directed by the company’s FDA consultants.
AppyScore Screen Test is designed to screen patients suspected of having appendicitis. Emergency room physicians are expected to use the device as part of a complete clinical workup. The key metric for the clinical study is the device’s Negative Predictive Value, which has been shown consistently in pre-FDA clinical studies to be approximately 98 percent.
For more information: www.aspenbiopharma.com