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: The sea anemone is sequenced, a team describes a CRISPR/Cas9-based approach to label specific sites in the genome, and more. 

In a short video, CNN introduces viewers to a fecal transplant poop donor and explains how the treatments are made.

Researchers are testing the use of transgenically altered diamondback moths as an alternative to pesticides in controlling the bugs.

Two recent papers published in Science and Nature Medicine describe work that may result in a universal vaccine for the flu.