Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

FDA Permits Marketing of First U.S. Test for TB Bacteria and Rifampicin Resistance

Published: Friday, July 26, 2013
Last Updated: Friday, July 26, 2013
Bookmark and Share
The U.S. Food and Drug Administration allowed marketing of the Xpert MTB/RIF Assay.

This is the first FDA-reviewed test that can simultaneously detect bacteria that cause tuberculosis (TB) and determine if the bacteria contain genetic markers that makes them resistant to rifampin, an important antibiotic for the treatment of TB.
 
The new test is less complex to perform than other previous FDA-cleared tests for the detection of TB bacteria. Test results, including the detection of TB bacteria and whether the bacteria are drug resistant, are available in approximately two hours. Traditional methods to detect drug resistant TB usually require one to three months.
 
“Less complex tests such as the Xpert MTB/RIF Assay can be used in more diverse settings,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological. “The early and rapid detection of rifampin-resistant TB can help curb the spread of drug-resistant TB, a major public health threat.”
 
TB is caused by bacteria that belong to a group known as Mycobacterium tuberculosis complex, which usually attacks the lungs. Not everyone infected with M. tuberculosis develops active TB, and only people with active TB can spread the bacteria to other people. Those with weakened immune systems are at a much higher risk for developing TB once infected with the bacteria, and TB can be fatal if left untreated. TB is a leading killer worldwide of people with HIV.
 
Common signs and symptoms of TB disease include: a bad cough lasting three weeks or longer, chest pain, coughing up blood, weakness and fatigue, and weight loss.
 
“New tools, including rapid and accurate diagnostic tests, are critical to advance the fight against TB,” said RADM Kenneth G. Castro, M.D., director of CDC’s Division of Tuberculosis Elimination. “Early diagnosis and effective treatment for both drug-susceptible and drug-resistant cases are essential for improving patient health, preventing the spread of disease to others, and ultimately, achieving our goal of TB elimination in the U.S.”
 
The FDA reviewed the Xpert MTB/RIF Assay through the de novo classification process, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.
 
In support of the de novo petition the manufacturer submitted data that included an assessment of the test’s accuracy in identifying the TB bacteria and the rifampin-resistant strains of the bacteria as compared to validated test methods.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,200+ scientific posters on ePosters
  • More Than 4,700+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.


Scientific News
ASMS 2016: Targeting Mass Spectrometry Tools for the Masses
The expanding application range of MS in life sciences, food, energy, and health sciences research was highlighted at this year's ASMS meeting in San Antonio, Texas.
Benchtop Automation Trends
Gain a better understanding of current interest in and future deployment of benchtop automated systems.
Some Women With PCOS May Have Adrenal Disorder
Researchers at NIH have found that a subgroup of women with PCOS, a leading cause of infertility, may produce excess adrenal hormones.
Alzheimer's Genetics Point To New Research Direction
A University of Adelaide analysis of genetic mutations which cause early-onset Alzheimer’s disease suggests a new focus for research into the causes of the disease.
Penn State, TB Alliance, and GSK Partner To Discover New Treatments For TB
A new collaboration between TB Alliance, GSK, and scientists in the Eberly College of Science seeks to find new small molecules that can be used to create antibiotics in the fight against tuberculosis (TB).
Manufactured Stem Cells To Advance Clinical Research
Clinical-grade cell line will enable development of new therapies and accelerate early-stage clinical research.
Faster Detection of Pathogens in the Lungs
Thanks to new molecular-based methods, mycobacterial pathogens that cause pulmonary infections or tuberculosis can now be detected much more quickly.
Contagious Cancers Are Spreading in Shellfish
Direct transmission of cancer among some marine animals may be more common than once thought, suggests a new study published in Nature by researchers at Columbia University Medical Center (CUMC).
Contagious Cancers Are Spreading in Shellfish
Direct transmission of cancer among some marine animals may be more common than once thought, suggests a new study published in Nature by researchers at Columbia University Medical Center (CUMC).
Anthrax Vaccine Protects Monkeys
Vaccination with the anthrax capsule—a naturally occurring component of the bacterium that causes the disease—completely protected monkeys from lethal anthrax infection, according to a recently published study.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,200+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!