Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Personalized Genetic Test Info Added To Warfarin Drug Labeling

This article was originally published in The Gray Sheet

Executive Summary

FDA is updating the label for the anti-clotting drug warfarin to inform physicians and patients about the usefulness of genetic testing before beginning therapy, but the agency will wait for data from ongoing studies of the tests before adding stronger recommendations for the tests

You may also be interested in...

Studies Find Limited Support For Genotyping-Guided Warfarin Dosing

The overall message of three trials published recently in The New England Journal of Medicine: “This pharmacogenetic testing has either no usefulness in the initial dosing of vitamin K antagonists or, at best, marginal usefulness, given the cost and effort required to perform this testing,” according to an editorial also in NEJM.

Genomic Tests For Warfarin Could Gain Coverage With Study Participation

CMS wants more evidence that genetic testing of individuals' responsiveness to the blood thinner warfarin actually improves health outcomes in Medicare populations, and the agency is using the national coverage process to call for randomized clinical trials

Genomic Tests For Warfarin Could Gain Coverage With Study Participation

Under a CMS proposal, genomic testing to predict warfarin response would receive Medicare coverage in the context of a clinical trial comparing the frequency of five kinds of adverse events with and without the tests.

Related Content




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts