APPY: This just released via their web site. Conference at 4:30 Eastern.
AspenBio Pharma to Proceed With FDA 510(k) Application for AppyScore(TM)
Management to Host Conference Call Today at 4:30 ET CASTLE ROCK, CO -- (MARKET WIRE) -- 03/12/2009 -- AspenBio Pharma, Inc. (NASDAQ: APPY), an emerging bio-pharmaceutical company dedicated to the development of novel drugs and diagnostics for humans and animals, today reported additional information and planned next steps for advancing its AppyScore™ product through the Food and Drug Administration ("FDA") application and clearance process following the recently completed pivotal clinical trial. AppyScore™ is the world's first 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.
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