The APPY1 Test is a novel, blood-based test designed to aid emergency physicians in the difficult challenge of evaluating suspected acute appendicitis patients to determine if they are at low risk for the disease. The current focus of the company is to develop the APPY1 Test to assist physicians in identifying children and adolescent patients at low risk for appendicitis as this population is at the highest risk of long term health effects associated with CT imaging.
Recently Venaxis completed a 503 patient pilot study involving pediatric and adolescent patients aged 2 to 20 with acute appendicitis symptoms who were enrolled from 11 hospital sites across the country. The data were analyzed to establish the baseline performance of the APPY1 Test as a potential aid to physicians in the identification of patients at low risk of acute appendicitis. The promising results of the pilot study served as a basis for the company to plan for a pivotal clinical trial and completion of the APPY1 Test optimization in a multimarker configuration.
The company expects to commence its clinical pivotal trial in Q1 2013 to validate the clinical utility of APPY1 Test in children and adolescent patients. When completed, the results of the trial will be submitted to the U.S. Food and Drug Administration to seek product marketing clearance. The APPY1 Test is designed to help emergency physicians identify patients who are at low risk for appendicitis, allowing clinicians to take a more conservative approach to patient management.
APPY1 Expected Product Path and Features
- High sensitivity and high negative predictive value.
- Fits in hospital lab workflow and ordinary turnaround time for hospital emergency department lab results.
- A multimarker blood test consisting of MRP 8/14 and C-reactive protein (CRP) biomarkers, along with White Blood Cell Count (WBC).
- The results of the individual biomarkers are analyzed using the company’s proprietary algorithm embedded in the APPYReader software. The objective of the test is to provide a more powerful and timely result to the clinician.
- The planned pivotal clinical trial for the Test will enroll children and adolescents suspicious for appendicitis as this population is believed to be at the highest risk from the long term negative health effects associated with CT imaging.
APPY1 Test is currently under investigation in the U.S. and the product is for export only.