AspenBio Pharma Pursues FDA Application Pathway For Appendicitis Blood Test
AspenBio Pharma has received an official response from FDA regarding AspenBio's pre-investigational device exemption ("IDE") application on AppyScore, the first blood-based screening/triage test for human appendicitis.
The official response from FDA has provided the company with the choice of pursuing either an FDA 510(k) (Pre-Market Notification) regulatory clearance or a PMA (Pre-Market Approval) for AppyScore. Based on this response, the company has now officially chosen to follow the 510(k) pathway. Generally the FDA's 510(k) application pathway has a much shorter time-line to clearance than the alternative PMA process. The company expects to complete the appropriate regulatory requirements to receive a 510(k) clearance for AppyScore before the end of 2008.
"This represents another major milestone in the advancement of our breakthrough screen test for appendicitis," said AspenBio's president and CEO, Richard Donnelly, "and demonstrates the strength of our initial clinical results and particularly the high sensitivity of AppyScore. We expect the FDA 510(k) to be a faster and easier path for regulatory clearance and market launch of this product. Most importantly, it creates the possibility of being able to begin marketing the first version of this test in the United States and certain international markets in 2008."
About AppyScore and the Need for a New Method of Diagnosing Appendicitis
AspenBio's AppyScore is the first blood-based Screen/Triage Test for human appendicitis. An estimated 5% to 7% of the world's population will get appendicitis in their lifetime. Annually, in the U.S. alone, an estimated 6 million patients enter hospital emergency rooms (ERs) complaining of abdominal pain, and who could potentially have appendicitis. Upon entering the ER, the current standard of care for these patients is to draw blood and urine samples, take vital signs and complete an initial physical health examination. Depending upon the results and clinical impression of the ER physician, a computed tomography (CT) scan may also be scheduled to assist in the diagnosis or rule out of appendicitis. CT scans generally take several hours to schedule and complete the procedure, and interpret the results. Moreover, CT scans are expensive, costing $1,500 to $3,000 each, and subject patients (mostly children and adolescents) to high levels of ionizing radiation.
Based upon the current standard of care, an estimated 700,000 patients in the U.S. are diagnosed with appendicitis and have their appendixes