Rochester, NY 2/11/2010 4:01:12 AM
AspenBio Pharma Inc. APPY Reports Conclusion of AppyScore
AspenBio Pharma Inc. APPY announced in a press release its interim analysis of their ongoing trials of AppyScore. Appyscore is the first blood-based test that can serve as an aid in evaluation of patients with acute appendicitis. Next steps for the drug include new filings with the FDA based on time estimates to complete the current trial and data analysis.
"We believe AppyScore has the potential to help improve physicians' evaluation of appendicitis, eliminating unnecessary CT scans and reducing radiation exposure risk for patients -- while also reducing health care costs," said Daryl J. Faulkner, Chief Executive Officer of AspenBio Pharma. "We continue to actively enroll patients in the ongoing clinical trial and believe that submitting a new 510(k) based on a full analysis of the data from this study will provide the most effective path to 510(k) clearance. Our new timeline includes finalizing the trial results and submitting the new 510(k) in the second quarter of 2010.
"In addition, we continue to make excellent progress advancing our second generation AppyScore product -- a stand-alone, state-of-the-art cassette and reader instrument platform -- and anticipate being in a position to begin clinical trials for this rapid assay in the second half of 2010," concluded Faulkner.
"Emergency medicine physicians need better diagnostic tools to help identify patients at low risk for appendicitis," said Angela Mills, MD, Assistant Professor, Department of Emergency Medicine, University of Pennsylvania School of Medicine and a consultant to AspenBio Pharma. "Additional test information that supplements the various modalities we currently use to evaluate patients with abdominal pain which might be due to acute appendicitis will guide more informed treatment decisions and, ultimately, support more efficient clinical management of patients."
The stock is trading 2.09 Down 0.22 (9.52%) as this is written.
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