bannerHON
img
HONnews
HONnews
img PATIENT / PARTICULIER img PROFESSIONNEL DE SANTE img WEBMESTRE img
img
 
img
HONcode sites
All Web sites
HONselect
News
Conferences
Images

Themes:
A B C D E F G H I
J K L M N O P Q
R S T U V W X Y Z
Browse archive:
2014: S A J J M A M F J
2013: D N O S

  Health Highlights: Aug. 1, 2014

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:

FDA to Regulate Medical Lab Testing

Tests developed and performed by medical labs will now be regulated by the U.S. Food and Drug Administration, the agency said Thursday.

In announcing the change, the FDA said these tests often determine critical treatment decisions, so more oversight is needed.

Tests that are sold to hospitals, laboratories, doctors' offices and the public have been regulated as medical devices for years, according to the New York Times. However, tests developed and performed by a single laboratory have not been regulated. Until now, the agency has claimed it had the authority to do so, but had chosen not to, the newspaper reported.

There are an estimated 11,000 lab-developed tests offered by 2,000 laboratories, according to the Times. Advances in DNA sequencing have spurred the growth of personalized medicine, in which genetic lab tests are used to tailor treatments for individuals with diseases such as cancer, the agency said.

"Inaccurate test results could cause patients to seek unnecessary treatment, or delay and sometimes forgo treatment altogether," FDA Commissioner Dr. Margaret Hamburg said in an FDA news release. The policy change "demonstrates the agency's commitment to personalized medicine, which depends on accurate and reliable tests to get the right treatment to the right patient."

The change has been opposed by some in the industry, who have claimed it would increase the cost of developing such tests and curb innovation, the Times reported.

But the FDA noted it would slowly implement the regulations over a nine-year period and would focus on tests where a wrong result would pose the highest risk for patients. It also said it would exempt tests for which there is no approved alternative and tests for rare diseases, the Times reported.

Copyright © 2014 HealthDay. All rights reserved. URL:http://consumer.healthday.com/Article.asp?AID=690371

Resources from HONselect: HONselect is the HON's medical search engine. It retrieves scientific articles, images, conferences and web sites on the selected subject.
Therapeutics
Insemination, Artificial
Equipment and Supplies
DNA
Neoplasms
The list of medical terms above are retrieved automatically from the article.

Disclaimer: The text presented on this page is not a substitute for professional medical advice. It is for your information only and may not represent your true individual medical situation. Do not hesitate to consult your healthcare provider if you have any questions or concerns. Do not use this information to diagnose or treat a health problem or disease without consulting a qualified healthcare professional.
Be advised that HealthDay articles are derived from various sources and may not reflect your own country regulations. The Health On the Net Foundation does not endorse opinions, products, or services that may appear in HealthDay articles.


Home img About us img MediaCorner img HON newsletter img Site map img Ethical policies img Contact