Luminex CYP2C19 Assay Cleared by FDA, CE Marked in Europe | GenomeWeb

NEW YORK (GenomeWeb News) – Luminex said after the close of the market on Monday that its xTAG CYP2C19 kit has been cleared for marketing by the US Food and Drug Administration and has received the CE Mark in Europe.

The test is intended to aid physicians in determining treatment plans based on genetic variants in the P450 2C19 gene. CYP2C19 is a gene that encodes a phase one drug metabolizing enzyme. The CYP2C19 enzyme is responsible for metabolizing a number of prodrugs and drugs for treating ailments such as ulcers, seizures, malaria, and anxiety, Luminex said.

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.

The Wall Street Journal reports that National Institutes of Health Director Francis Collins' response to contamination concerns at the agency might have delayed care.

The final revision of the Common Rule doesn't include the proposed change requiring consent for leftover biospecimens.

The first Reproducibility Project: Cancer Biology papers show mixed results.

In Nature this week: mobile phone-based targeted DNA sequencing, and more.