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.

Get the full story

This story is free
for registered users

Registering provides access to this and other free content.

Register now.

Already have an account?
Login Now.

In PNAS this week: transcript patterns in drug-resistant cancer cells, function of high-altitude adaption gene, and more.

Monitoring gene expression changes could help sniff out athletes using performance-enhancing drugs, New Scientist says.

The University of Southern California lodges a cross-complaint in its legal dispute with the University of California, San Diego, over a large Alzheimer's disease project.

In PLOS this week: gene fusion in premature ovarian failure, population patterns in the Franciscana dolphin, and more.