AspenBio files AppyScore with US FDA
This article was originally published in Clinica
Executive Summary
AspenBio Pharma has filed a 510(k) application with the US FDA for its troubled appendicitis blood test, AppyScore. The product is an enzyme-linked immunosorbent assay (ELISA) test intended to be used in conjunction with other diagnostic methods, such as clinical exam or imaging, in patients with suspected appendicitis. AspenBio has persevered with the test, despite reporting disappointing results from a pivotal trial in January (see Clinica No 1333, p 27). The 510(k) submission includes data using a cut-off point of 14, which show a higher sensitivity and negative predictive value than with the original cut-off value of 20. The Castle Rock, Colorado firm is also developing a different version of AppyScore, a 15-minute rapid assay with reader instrument, which it hopes to start clinical trials with in early 2010.