NEW YORK (GenomeWeb News) – Venaxis today announced it has submitted a 510(k) application to the US Food and Drug Administration to market its biomarker assay for identifying patients at low risk for appendicitis.
Venaxis added that it has requested concurrent de novo determination for the assay called the APPY1 Test. Earlier this month, the Castle Rock, Colo.-based company announced top-line results from the pivotal US study for the test, saying APPY1 had a negative predictive value of 97.3 percent, sensitivity of 96.9 percent, and specificity of 37.8 percent.
APPY1 is a blood-based lateral flow test intended to identify patients who are at low risk for appendicitis and, therefore, may not be candidates for additional imaging tests. It measures three biomarkers: C-reactive protein, white blood cell count, and the MRP8/14 protein.
Venaxis completed the first utility analysis of the CE-marked test last summer.