Blood-Based Diagnostic Test for Appendicitis Undergoes Clinical Evaluation

A blood-based diagnostic test for human appendicitis is now in the final stage of clinical evaluation.

Called AppyScore, the 45-minute enzyme-linked immunosorbant assay (ELISA) for appendicitis is being studied in a U.S. Food and Drug Administration (FDA; Rockville, MD; USA) 510(k) clinical trial. The study enrollment is focused on patients arriving at hospital emergency rooms with a primary complaint of abdominal pain. Qualified patients are further narrowed with criteria related to medical history and duration and location of abdominal pain.

The blood test was developed by AspenBio Pharma Inc. (Castle Rock, CO, USA), an emerging biopharmaceutic company dedicated to the development of diagnostics and novel drugs for humans and animals. The company anticipates completing its FDA 510(k) application in early 2009.

Results of unpublished pilot data suggest that the assay performs with consistently high sensitivity and has shown a trend of improved specificity. Further analysis of this pilot data suggests that AppyScore in combination with other existing standard of care tests, including white blood count and computed tomography, may provide a significant improvement in the quality of diagnostic information available to the physician. While results in any large blind trial cannot be assured, the company expects that the current 800-patient trial will demonstrate this improved clinical utility.

Although AppyScore is the company's number one priority, AspenBio Pharma continues to make progress on two additional formats of the appendicitis test that are in its product pipeline. The additional versions are designed to provide faster results and are less labor intensive.

The first of these two additional test versions includes a state-of-the-art diagnostic instrument that was developed in conjunction with a medical instrument company. It is designed to provide results in approximately 15 minutes after a prepared sample is deposited into a test device and processed by the instrument. The third version in the appendicitis blood test pipeline is a disposable point-of-care device designed to be used in specific segments of the worldwide market.

Related Links:
U.S. Food and Drug Administration
AspenBio Pharma Inc.