Results from AspenBio Pharma’s (NASDAQ: APPY) recently completed 503-patient pilot study of AppyScore™ will be presented from the podium at the upcoming annual scientific meeting of the Society for Academic Emergency Medicine (SAEM) being held May 9-12, 2012 in Chicago.
The AppyScore clinical study included pediatric and adolescent patients, ages 2-20, with symptoms suspicious for acute appendicitis who were evaluated at 11 hospital sites across the country. Results for the AppyScore test showed a negative predictive value of 97% and sensitivity of 97% and the study suggests that approximately one-third of patients were referred for CT scans unnecessarily, as these patients did not have acute appendicitis. A single abdominal CT scan exposes patients to a radiation dose equivalent to 100 to 800 chest x-rays, according to a February 2010 report released by the FDA, “Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging.” Abdominal pain is the number one reason for hospital emergency department visits, and appendectomy is a major reason for emergency abdominal surgery.
“The use of AppyScore has the potential to reduce the number of costly abdominal CT scans and associated exposure to harmful radiation,” said Stephen T. Lundy, president and CEO of AspenBio Pharma. “In addition, radiology procedures can result in significant wait times and patient backlog in hospital emergency rooms. These factors have created an unmet clinical need for a quick blood test that can provide doctors with a high level of confidence that low-risk patients may be conservatively managed, and potentially not require CT scans in the workup for possible appendicitis.
“An AppyScore pivotal clinical trial is planned for later this year, which is planned to be followed by the submission of results to the FDA seeking market clearance,” added Mr. Lundy. “We also are advancing plans to certify AppyScore with the CE mark later in 2012, required for the potential sale and distribution of AppyScore in regions of Europe.”AppyScore is a multi-marker blood-based test panel consisting of the company’s patented MRP 8/14 biomarker and C-reactive protein, along with white blood cell count. AppyScore is designed to aid emergency physicians in the identification of children and adolescents at low risk when acute appendicitis is suspected due to abdominal pain. The AppyScore test is in development and not yet approved for use. In the U.S., approximately 9 million people annually enter hospital emergency rooms with abdominal pain. Currently, CT scanning is frequently used for patients suspicious for appendicitis due to the lack of other more definitive tools. However, CT scans take time, are expensive, and published studies have reported increased concern among clinicians about the potential long-term harmful effects of CT radiation.