AspenBio Pharma, Inc. reported additional information and planned next steps for advancing its AppyScore product through the FDA application and clearance process following the recently completed pivotal clinical trial. AppyScore is the blood-based test being developed as an aid in the diagnosis of human appendicitis. Based upon the assessment to date, the following key points are made: • The company confirms its plan to file a 510(k) with the FDA to seek clearance of the AppyScore ELISA product used in the pivotal trial as soon as the extensive filing application can be completed and reviewed by the Company's regulatory advisors. • AspenBio expects that the product indication will be as an, "Aid in the Diagnosis of Appendicitis," to be used in conjunction with other physical and laboratory tests. • The clinical trial data analysis supports that the AppyScore analyte MRP8/14, provides valuable clinical information in the diagnosis of patients with lower right quadrant abdominal pain. • AspenBio believes that the AppyScore test, upon commercialization, will have a sensitivity and negative predictive value of greater than 90%. • Data from the pivotal trial also demonstrated that when the AppyScore is interpreted in combination with other commonly used indicators, such as white blood count (WBC), the sensitivity and negative predictive value will be higher. The preliminary data as disclosed in January 2009 has been further studied and the findings of the study can be clarified. This pivotal study included an unexpected number of patients who presented with mild appendicitis when compared to peer reviewed published literature statistics. This was especially prevalent at one of the hospital sites which enrolled the largest number of patients in the study. While these factors reduced the sensitivity of the test in this study population (as one might expect for a marker related to disease progression), it has been concluded that the trial results are statistically valid and supportable and favorably demonstrate the linear relationship between the AppyScore level and pathologically proven appendicitis in patients with acute abdominal pain. The company's commercialization plan to maximize the value and effectiveness of the AppyScore product is to advance the FDA 510(k) clearance process based upon the recent trial data and simultaneously complete development and testing of the rapid assay with reader instrument. This reader instrument is in late prototype development and has many features and benefits over the current ELISA test. Such benefits include rapid results in 15 minutes or less, a fully integrated stand alone assay system that significantly reduces operator dependence and a design to interface with the hospital's LIS system.