Venaxis Enters Commercial Development Agreements of Appendicitis Test

The in vitro diagnostic company Venaxis, Inc. (Castle Rock, CO, USA) has added two commercial development agreements. MOSS SpA, based near Milan, covers all hospitals across Italy, which collectively record approximately 24 million emergency department visits per year. SAVAS Medikal, Inc., based in Istanbul, covers all hospitals across Turkey and these hospitals estimate 35 million emergency visits per year.

These will be part of the initial phase of the European launch of its CE-marked blood-based appendicitis test, APPY1. While the company is trying to obtain US Food and Drug Administration (Silver Spring, MD, USA) clearance for the test, the initial launch for APPY1 is ongoing in select European territories.

MOSS and SAVAS Medikal will market development activities within their respective territories. Each one has submitted initial stocking purchase orders for the APPY1 test/system. Venaxis announced a similar agreement with EMELCA Bioscience earlier this year that covers Belgium, Luxembourg, and The Netherlands.

The APPY1 test combines lateral flow technology, inflammatory biomarkers, and a diagnostic algorithm. It uses a multimarker approach to identify patients at low risk for acute appendicitis. The test measures the concentrations of myeloid-related protein calprotectin (MRP 8/14) and C-reactive protein (CRP) in ethylenediaminetetraacetic acid (EDTA)-plasma by lateral flow immunoassay. MRP 8/14, CRP, and a manually entered WBC count are then computed by the reader’s preprogrammed proprietary algorithm to give an APPY1 test result and a qualitative interpretation to facilitate the utility of the results.

The appendicitis test has projected high sensitivity and negative predictive value and is being developed to help identify patients at low risk for acute appendicitis (AA), allowing for more conservative patient management. APPY1 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 the highest risk of long-term health effects associated with CT imaging.

Related Links:
Venaxis
US Food and Drug Administration