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AspenBio Pharma Reports Strong Results with Appendicitis Triage Blood Test from Large Multiple Hospital Study
Date:9/28/2007

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A total of 97 of 311 or 31% of patients had pathology-confirmed appendicitis in the study. AppyScore was able to correctly identify 95 of 97 patients with pathology-confirmed appendicitis. This exceptionally high sensitivity level of 98% for detecting the actual disease condition is considered statistically significant (95% CI = 93 to 99.9). Practically, this means a patient with a negative AppyScore has an extremely low likelihood of having appendicitis. This high sensitivity is a key hallmark for a successful screen test.

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 that an average of 18.6% of patients (ranging from a low of 10.6% to a high of 27.8%) were incorrectly diagnosed as not having appendicitis and were sent home, only to return to the emergency room with acute appendicitis in an advanced or burst condition. If the Graff report is representative of the state of the art for appendicitis diagnostics, then the 98% sensitivity of AppyScore in the company's study demonstrates the substantial impact this screen test could have for life threatening mis-diagnoses. The false negative diagnosis of appendicitis could become much less frequent using the AppyScore concept, resulting in fewer patients with appendicitis being erroneously sent home.

In the AspenBio study, there were a total of 109 appendectomies (appendix removal surgeries) of which only 97 had pathology-confirmed appendicitis, indicating there were 12 individuals or 11% who had a normal appendix removed. These 12 surgeries were classified as unnecessary on the basis of normal pathology findings. AppyScore would have successfully identified 7 of 12 (or 58%) of these unnecessary surgeries. In the US alone, an estimated 1-in-5 to 1-in-7 (14% to 20%) appendectomy surgeries remove a normal appendix due to an incorrect diagnosis.
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SOURCE AspenBio Pharma, Inc.
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