AspenBio Pharma, Inc. announced that it has filed a Premarket Notification 510(k) with the US FDA for its AppyScore Test.
This FDA 510(k) submission represents a major milestone in advancing our AppyScore appendicitis test platform toward commercialization, said Daryl Faulkner, chief executive officer of AspenBio. The experienced group that has prepared this submission including experts inside and outside of the company has produced a complete, highly professional and quality submission package.
The AppyScore Test is an ELISA test system that is used to quantitatively measure S100A8/A9 heterodimer complex in blood. It is an in vitro diagnostic device that is intended to be used as an adjunctive tool for the diagnosis of acute appendicitis in conjunction with additional diagnostic modalities (such as clinical exam, basic laboratory testing, imaging) in patients with abdominal pain that is suspicious for acute appendicitis.
AppyScore when used in combination with standard diagnostic modalitie helps health care professionals to accurately diagnose acute appendicitis. Clinical trial results suggested that AppyScore has sufficient sensitivity and specificity, and can be used as adjunctive diagnostic tool in an emergency department setting.