The final results from AspenBio Pharma’s (NASDAQ: APPY) 503-patient pilot study of AppyScore™ will be presented from the podium at the annual meeting of the Society for Academic Emergency Medicine being held in Chicago, May 9-12.
AppyScore is a multi-marker blood-based test panel consisting of the company’s patented MRP 8/14 biomarker and C-reactive protein, along with white blood cell count. AppyScore is designed to aid emergency physicians in the identification of patients at low risk when acute appendicitis is suspected due to abdominal pain. The AppyScore test is in development and not yet approved for use. Abdominal pain is the number one reason for hospital emergency department visits, and appendectomy is the number one reason for emergency abdominal surgery.
Enrollment and delivery of the total patient samples for the 2011 pilot study was completed in December 2011, and included pediatric and adolescent patients ages 2-20 with symptoms suspicious for acute appendicitis who were enrolled at 11 hospital sites across the country. Final data analysis using the multi-marker panel on the total 503 patient samples collected in the 2011 pilot study was recently finalized and demonstrated results for the AppyScore test at a negative predictive value of 97%, sensitivity of 96%, and specificity of 43%.
"Evaluating children for appendicitis is difficult, and strategies have been sought to improve the precision of the diagnosis,” said David S. Huckins, M.D., a clinical investigator in the AppyScore pilot study. “Computed tomography (CT) is widely used, but there are concerns regarding the large dose of ionizing radiation and risk of subsequent radiation-induced malignancy. I believe that the AppyScore results demonstrated in this study are very encouraging.”In the U.S., approximately 10 million people annually enter hospital emergency rooms with abdominal pain. Currently, CT scanning is frequently used for screening of appendicitis due to the lack of other more definitive tools. However, CT scans take time, are expensive, and published studies have reported increased concern among clinicians about the potential harmful effects of CT radiation.