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 Science this week: self-assembly of DNA components in solution, and more.

Genetics and Molecular Research retracts two gastric cancer papers for being "substantially equal" to other papers, according to Retraction Watch.

A new analysis indicates that the Ebola virus behind the current West African outbreak is mutating at about the same rate as other Ebola viruses.

With the launch of Scott Kelly into space today, the study of him and his earthbound brother to disentangle the effects of life in space from the effects of genetics kicks off.