AspenBio Pharma Inc , a bio-science company dedicated to the development of novel diagnostics and drugs for humans and animals, announced that Dr John F. Bealer, presented a paper titled, ‘S100A8/A9: A Sensitive Diagnostic Blood Marker for Acute Appendicitis,’ at the Society for Academic Emergency Medicine’s 2009 Annual Meeting.

"This presentation of our study data at this prestigious gathering of the nation’s top emergency medical professionals is a milestone event for AspenBio," said Dr. Robert Caspari, COO and CMO of AspenBio, "and it is the first such presentation of its kind to the medical community. We believe AppyScore’s successful advancement and commercialization can lead to extensive positive changes in emergency medicine for the diagnosis of appendicitis."

The paper demonstrated the significant sensitivity of the blood marker which underlies AppyScore’s patented diagnostic technology, as expressed in the results of the company’s 2008 pilot study. The test incorporates a patented assay that detects a marker in the blood associated with the inflammation seen with appendicitis, and is anticipated to be the first and only such test available in the world focused on this condition.

It addresses the need for an objective, quantitative, rapid, safe, and economical diagnostic test for human appendicitis.
Following the analysis of AppyScore pivotal FDA clinic trial completed earlier this year, AspenBio is advancing AppyScore towards Food and Drug Administration ("FDA") application and clearance process, and plans to file a 510(k) application with the FDA by the end of the second quarter of 2009.

In both preliminary clinical trials and a formal FDA clinical trial, AspenBio has tested its assay in over a thousand patients and has consistently shown the AppyScore blood test, when used in conjunction with other commonly used medical modalities, was able to aid in the diagnosis of appendicitis at a sensitivity and negative predictive value greater than 90%.

AppyScore also has the potential to significantly reduce the time required to diagnose appendicitis cases due to the speed of the AppyScore test results, as well as potentially reducing the number of costly abdominal CT scans and the associated exposure to harmful radiation.

Source: AspenBio Pharma Inc