Compelo Medical Devices is using cookies

We use them to give you the best experience. If you continue using our website, we'll assume that you are happy to receive all cookies on this website.

ContinueLearn More
Close
Dismiss

AspenBio Pharma Discloses Clinical Study Preliminary Results of AppyScore

AspenBio Pharma, Inc. announced the initial preliminary data from its Food and Drug Administration (FDA) clinical trial for AppyScore, which is the first blood-based test as an aid in the diagnosis of human appendicitis and an update on planned steps for obtaining FDA clearance. The preliminary results demonstrated the relationship between AppyScore and the risk of pathologically proven appendicitis in patients with acute abdominal pain, although data analysis is still ongoing. Data analysis also aims to determine the optimal clinical use of the test in conjunction with other standard diagnostic tests. The results showed that the negative predictive value using the previously suggested optimal threshold (cut-point) of AppyScore at 20 is 83% as compared to 96% that was observed in the earlier pilot study. Utilizing a lower cut-point a significantly higher negative predictive value was observed on futher analysis. "We are encouraged the data from this study continues to support our longstanding belief that AppyScore, in conjunction with other standard diagnostic approaches, could provide a significant improvement in the evaluation of abdominal pain," said Richard Donnelly, president and CEO of AspenBio Pharma. "Along with our FDA consultants we are evaluating our next steps regarding an FDA premarket notification '510(k)' submission to secure clearance as a diagnostic tool as an aid in the diagnosis of acute appendicitis. However, we do not know if the resulting data will be acceptable or sufficient for FDA clearance for our intended use until such determinations are made by the FDA. Furthermore we continue to evaluate the best course of action for the company given our current product plans and objectives. We believe we will be in a position to provide additional information on our FDA 510(k) submission plans and expected timing in the next several weeks." After elimination of subjects who were not eligible for study criteria, the study encompassed a total of 586 individuals out of which 168 (28.7%) had pathology confirmed acute appendicitis. In addition, there were a total of 168 appendectomies (appendix removal surgeries) of which 148 had pathology-confirmed appendicitis. The conclusion was there were 20 individuals or 12% who had a normal appendix removed and AppyScore correctly identified 10 (or 50%) of these unnecessary appendix surgeries as negative. The company will hold a conference call on Thursday, January 22, 2009 at 4:30 PM Eastern Time to discuss these preliminary results and related FDA plans.