AspenBio submits IDE for appendicitis blood test:
This article was originally published in Clinica
Executive Summary
AspenBio Pharma has started the ball rolling in seeking approval for its appendicitis blood test, submitting a pre-investigational device exemption to the US FDA. The AppyScore triage test was found to reduce unnecessary surgery by 58% in recent pre-FDA trials of 471 patients. The test also showed a sensitivity of 98% - more accurate than CT scans which are currently considered the best diagnostic method for the condition. Furthermore, CT can be time consuming, expensive, and exposes patients to radiation, claimed the Castle Rock, Colorado firm. AspenBio sees a potentially large market for the test, claiming that some 6 million US patients each year enter hospital emergency rooms complaining of abdominal pain which could be appendicitis.