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AspenBio Outlines Steps for FDA 510(k) Clearance of AppyScore(TM), the First Blood-Based Screen/Triage Test for Human Appendicitis
Date:12/27/2007

Company Expects FDA 510(k) Clearance Before End of 2008; Ongoing Pre-FDA

Clinical Data Collection Continues to Support High Test Sensitivity

CASTLE ROCK, Colo., Dec. 27 /PRNewswire-FirstCall/ -- AspenBio Pharma, Inc. (Nasdaq: APPY), an emerging bio-pharmaceutical company dedicated to the development of novel drugs and diagnostics for animals and humans, has outlined plans for submitting its final data package to the United States Food and Drug Administration ("FDA") for market approval of AppyScore(TM), 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:

1) Pivotal clinical data trial definition and completion under FDA

regulatory guidelines using GMP validated test version

2) Finalization of logistics with cGMP manufacturer of the AppyScore test

3) 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 non-clinical laboratory performance testing, like assay precision and analytical sensitivity, as well as clinical testing in the field. AspenBio has selected a manufacturer for the AppyScore Screen Test with extensive experience in manufacturing in-vitro diagnostic devices according to 21 CFR 820, and which has been registe
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SOURCE AspenBio Pharma, Inc.
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