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

e to begin marketing the first version of this test in the United States and certain international markets in 2008."

About AppyScore and the Need for a New Method of Diagnosing Appendicitis

AspenBio's AppyScore is the first blood-based Screen/Triage Test for human appendicitis. An estimated 5% to 7% of the world's population will get appendicitis in their lifetime. Annually, in the U.S. alone, an estimated 6 million patients enter hospital emergency rooms (ERs) complaining of abdominal pain, and who could potentially have appendicitis. Upon entering the ER, the current standard of care for these patients is to draw blood and urine samples, take vital signs and complete an initial physical health examination. Depending upon the results and clinical impression of the ER physician, a computed tomography (CT) scan may also be scheduled to assist in the diagnosis or rule out of appendicitis. CT scans generally take several hours to schedule and complete the procedure, and interpret the results. Moreover, CT scans are expensive, costing $1,500 to $3,000 each, and subject patients (mostly children and adolescents) to high levels of ionizing radiation.

Based upon the current standard of care, an estimated 700,000 patients in the U.S. are diagnosed with appendicitis and have their appendixes surgically removed. However, an estimated 1 in 5 to 1 in 7 (14% to 20%) appendectomy surgeries remove a normal appendix due to an incorrect diagnosis. This would mean more than a 100,000 unnecessary surgeries occur every year at a great cost to patients, insurance companies and create unnecessary pain, suffering and risk to human life and possibly other ongoing patient health issues.

Not properly detecting real cases of appendicitis is also a major problem. A large independent research report (Graff et al., 2000 Acad Emerg Med Vol 7 n 11 pp 1244-55) of approximately 1,026 appendicitis patients from 12 hospitals across the northeastern United States reported th
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SOURCE AspenBio Pharma, Inc.
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