Corporate Banner
Satellite Banner
Biomolecular Screening
Scientific Community
 
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
Platelets are the Pathfinders for Leukocyte Extravasation During Inflammation
Findings from the study could help in the prevention and treatment of inflammatory pathologies.
Benchtop Automation Trends
Gain a better understanding of current interest in and future deployment of benchtop automated systems.
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).
Molecular Map Provides Clues To Zinc-Related Diseases
Mapping the molecular structure where medicine goes to work is a crucial step toward drug discovery against deadly diseases.
Genetic Research Can Significantly Improve Drug Development
With drug development costs topping $1.2bn (£850 million) to get a single treatment to the point it can be sold and used in the clinic, could genetic analysis save hundreds of millions of dollars?
New Method Opens Door to Development of Many New Medicines
Findings from TSRI reveal human proteins are better drug targets than previously thought.
Diagnosing Systemic Infections Quickly, Reliably
Team develop rapid and specific diagnostic assay that could help physicians decide within an hour whether a patient has a systemic infection and should be hospitalized for aggressive intervention therapy.
What Makes a Good Scientist?
It’s the journey, not just the destination that counts as a scientist when conducting research.
Blood Test That Detects Early Alzheimer’s Disease
A research team, led by Dr. Robert Nagele from Rowan University School of Osteopathic Medicine and Durin Technologies, Inc., has announced the development of a blood test that leverages the body’s immune response system to detect an early stage of Alzheimer’s disease – referred to as the mild cognitive impairment (MCI) stage – with unparalleled accuracy.
A New Approach to Chemical Synthesis
Communesins, originally found in fungus, could hold potential as cancer drugs.
SELECTBIO

SELECTBIO Market Reports
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!