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AspenBio Pharma Pursues FDA 510(k) Application Pathway for Appendicitis Blood Test
Date:11/27/2007

Company now officially following an FDA 510(k) (Pre-Market Notification) Pathway for AppyScore(TM), the First Blood-based Screening and Triage Test

for Human Appendicitis

CASTLE ROCK, Colo., Nov. 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 received an official response from the Food and Drug Administration (FDA) Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) regarding AspenBio's pre-investigational device exemption ("IDE") application on AppyScore(TM), the first blood-based screening/triage test for human appendicitis.

The official response from FDA has provided the company with the choice of pursuing either an FDA 510(k) (Pre-Market Notification) regulatory clearance or a PMA (Pre-Market Approval) for AppyScore. Based on this response, the company has now officially chosen to follow the 510(k) pathway. Generally the FDA's 510(k) application pathway has a much shorter time-line to clearance than the alternative PMA process. The company expects to complete the appropriate regulatory requirements to receive a 510(k) clearance for AppyScore before the end of 2008.

"This represents another major milestone in the advancement of our breakthrough screen test for appendicitis," said AspenBio's president and CEO, Richard Donnelly, "and demonstrates the strength of our initial clinical results and particularly the high sensitivity of AppyScore. We expect the FDA 510(k) to be a faster and easier path for regulatory clearance and market launch of this product. Most importantly, it creates the possibility of being abl
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SOURCE AspenBio Pharma, Inc.
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