The results from AspenBio Pharma's (NASDAQ: APPY) 503-patient pilot study of AppyScore™ will be presented from the podium the upcoming West Region meeting of the Society for Academic Emergency Medicine (SAEM) being held in Las Vegas, March 16-17.
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. Abdominal pain is the number-one reason for hospital emergency department visits, and appendectomy is the number-one reason for emergency abdominal surgery.
The pilot study included pediatric and adolescent patients ages 2-20 with symptoms suspicious for acute appendicitis who were enrolled at 11 hospital sites across the country. Results for the AppyScore test showed a negative predictive value of 97% and sensitivity of 96%.
"Evaluating children and adolescents for appendicitis is difficult, and strategies have been sought to improve the precision of the diagnosis," said David Spiro, M.D., a clinical investigator in the AppyScore pilot study and a pediatric emergency medicine specialist at Oregon Health & Sciences University, Portland, Ore. "Development of a quick and reliable blood test will provide clinicians with a tool that can be used to help reduce unnecessary exposure to ionizing radiation."
In the U.S., approximately 10 million people annually enter hospital emergency rooms with abdominal pain. Currently, CT scanning is frequently used for screening of 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 harmful effects of CT radiation. 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."
The use of AppyScore has the potential to reduce the number of costly abdominal CT scans and associated exposure to harmful radiation. 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 will be followed by the submission of results to the FDA for market clearance," added Stephen T. Lundy, president and CEO of AspenBio Pharma. "We also are advancing plans to certify AppyScore with the CE mark, allowing for the potential sale and distribution of AppyScore in regions of Europe before the end of the year."