AspenBio Pharma (APPY) Updates on Anticipated Milestones for FY12
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AspenBio Pharma, Inc. (Nasdaq: APPY), laid out the 2012 anticipated milestones in its path towards commercialization of AppyScore, its unique multi-marker blood test in development designed to help physicians rule out acute appendicitis in children and adolescents entering the emergency room with symptoms of the disease.
AppyScore is a multi-marker blood test panel consisting of the company’s patented MRP 8/14 biomarker and C - reactive protein, along with White Blood Cell Count. The scoring results of these individual components will be analyzed using the company’s proprietary algorithm software embedded in the AppyScore cassette reader, to provide an AppyScore result to the clinician.
The pilot data results also support the company’s belief that AppyScore could reduce the number of children and adolescents exposed to harmful radiation from CT scans, which currently are used routinely in diagnosing appendicitis.
Major AppyScore milestones to be accomplished are:
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AppyScore is a multi-marker blood test panel consisting of the company’s patented MRP 8/14 biomarker and C - reactive protein, along with White Blood Cell Count. The scoring results of these individual components will be analyzed using the company’s proprietary algorithm software embedded in the AppyScore cassette reader, to provide an AppyScore result to the clinician.
The pilot data results also support the company’s belief that AppyScore could reduce the number of children and adolescents exposed to harmful radiation from CT scans, which currently are used routinely in diagnosing appendicitis.
Major AppyScore milestones to be accomplished are:
- Finish the conversion of AppyScore to a multi-marker or “multivariate” blood-based test on the AppyScore reader cassette system – this is currently near completion;
- Hold a collaboration meeting with FDA regarding the product’s intended use, clinical strategy for test configuration and regulatory pathway;
- Submit a pre-IDE information package, including the pivotal clinical trial protocol and statistical analysis plan to the FDA;
- Commence the pivotal clinical trial, planned for mid-2012;
- Certify AppyScore for CE marking, mid-2012; initiate European AppyScore commercialization by the end of the year; and
- Complete the pivotal clinical trial patient enrollment, analyze data, and submit pivotal clinical trial results to FDA - planned for late 2012 into early 2013.
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