AspenBio Pharma, a developer of blood-based tests, has presented its 503-patient pilot study data of a multi-marker blood-based test, AppyScore.
AppyScore which comprises of the company’s patented MRP 8/14 biomarker and C-reactive protein, along with white blood cell count, 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 study enrolled pediatric and adolescent patients aged 2-20 with symptoms suspicious for acute appendicitis.
Results of the study demonstrated that the AppyScore test showed a negative predictive value of 97% for absence of acute appendicitis in children and adolescents and sensitivity of 96%.
AspenBio Pharma president and CEO Stephen Lundy said an AppyScore pivotal clinical trial is planned for later this year, which will be followed by the submission of results to the US Food and Drug Administration 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 company said it has presented AppyScore’s results at the west region meeting of the society for academic emergency medicine (SAEM) held at Las Vegas from 16-17 March.