Blood test for appendicitis flunks in trail
A simple blood test, which showed early promise to detect appendicitis, has failed in midway clinical studies, drug maker AspenBio Pharma Inc. has reported.
Patient studies named AppyScore test showed that the blood test will not be an efficient and fool-proof method to diagnose acute appendicitis. AppyScore was the first blood-based test designed to aid in the evaluation of patients suspected of acute appendicitis.
Preliminary studies indicated that AppyScore ELISA triage screen test could be a highly effective test in identifying patients with acute appendicitis. This marker demonstrated a strong correlation with the severity of the appendicitis.
The appendicitis blood test scoring system was designed to numerically measure the blood marker levels that guide the physician in determining not only the presence but also the potential stage or severity of appendicitis being experienced by the patient.
Determining the stage or severity of appendicitis helps the physician assess the level of possible danger and the potential for the appendix to perforate, possibility leading to life-threatening complications.
AspenBio studied the test in a supplemental clinical trial involving more than 400 patients from the emergency departments of over a dozen well-known hospitals across the United States.
"We had hoped that the results of this trial would allow for an FDA submission of the ELISA-based test, thus providing a predicate device for the cassette-based test, however, it was not our intent to launch AppyScore in this format," says Steve Lundy, AspenBio Pharma's president and chief executive officer.
Aspen will now proceed with the development of another version of the test to detect appendicitis, a common acute surgical problem primarily affecting children and young adults under 30 years of age.
Acute appendicitis occurs between 24 and 36 hours from the initiation of symptoms to the point where if it is not operated on and removed it may perforate or burst causing a potentially life threatening event for the patient.