Venaxis has filed a 510(k) premarket submission for the APPY1 Test, a rapid, multiple biomarker-based index assay designed for identifying patients that are at low risk for appendicitis.
The company has requested concurrent de novo determination and 510(k) clearance from the US Food and Drug Administration (FDA).
The APPY1 Test is being developed initially for pediatric, adolescent and young adult patients with abdominal pain, as this population is at the highest risk for appendicitis and has the highest risk of long-term health effects associated with CT imaging.
In its pivotal US clinical study, the APPY1 Test performed with negative predictive value (NPV) of 97.3%, which is the primary metric for the APPY1 Test, sensitivity of 96.9% and specificity of 37.8% on the target population.
NPV and sensitivity are the key performance measures, and the results exceeded the clinical study protocol objectives and the results from Venaxis’ previous pilot study.
Venaxis president and CEO Steve Lundy said the company is highly encouraged by the positive results from its pivotal clinical study, and he would like to thank all of company’s clinical partners and staff for the excellent work on this pivotal trial and submission.
"We look forward to working collaboratively with the FDA as they review our submission," Lundy added.