AspenBio Pharma has reported results from a pivotal clinical study of its AppyScore blood test, designed for the diagnosis of children and adolescents presenting abdominal pain.
AppyScore is a multimarker blood-based test panel consisting of the company’s MRP 8/14 biomarker and C-reactive protein, along with white blood cell count.
The blood test will help identify those patients who are at low risk for appendicitis when acute appendicitis is suspected due to abdominal pain, enabling physicians to take a conservative approach to patient management.
The 503-patient pilot study enrolled paediatric and adolescent patients aged from two to 20, with symptoms for acute appendicitis at 11 hospital sites across the US, finding that AppyScore showed a negative predictive value of 97% and sensitivity of 96% for the absence of acute appendicitis.
Oregon Health & Sciences University, US, paediatric emergency medicine specialist and clinical investigator of the AppyScore pilot study David Spiro said development of a reliable blood test will provide clinicians with a tool which can be used to help reduce unnecessary exposure to ionising radiation.
AspenBio Pharma president and CEO Stephen Lundy said an AppyScore pivotal clinical trial is planned for later in 2012, which will be followed by the submission of results to the Food and Drug Administration (FDA ) for market clearance.
"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," Lundy added.
The AppyScore test has the ability to reduce radiation exposure risks arising from use of abdominal CT scans, while minimising healthcare costs, patient wait times and patient backlogs in hospital emergency rooms. The aim of the company is to use AppyScore in children and adolescents suspicious of the disease, as this population is at the highest risk of the long-term health effects associated with CT imaging.