Corporate Banner
Satellite Banner
Molecular & Clinical Diagnostics
Scientific Community
Become a Member | Sign in
Home>News>This Article

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
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 2,600+ scientific posters on ePosters
  • More than 3,800+ 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 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
Will Brain Palpation Soon Be Possible?
Researchers have developed non-invasive brain imaging technique which provides the same information as physical palpation.
Groundbreaking Computer Program Diagnoses Cancer in Two Days
Researchers have combined genetics with computer science and created a new diagnostic technology can with 85 per cent certainty identify the source of the disease and thus target treatment and, ultimately, improve the prognosis for the patient.
Detecting HIV Diagnostic Antibodies with DNA Nanomachines
New research may revolutionize the slow, cumbersome and expensive process of detecting the antibodies that can help with the diagnosis of infectious and auto-immune diseases such as rheumatoid arthritis and HIV.
Horse Illness Shares Signs of Human Disease
Horses with a rare nerve condition have similar signs of disease as people with conditions such as Alzheimer’s, a study has found.
Compound Doubles Up On Cancer Detection
Researchers have found that tagging a pair of markers found almost exclusively on a common brain cancer yields a cancer signal that is both more obvious and more specific to cancer.
The Age of Humans Controlling Microbes
Engineered bacteria could soon be used to detect environmental toxins, treat diseases, and sustainably produce chemicals and fuels.
Predictive Model for Breast Cancer Progression
Biomedical engineers have demonstrated a proof-of-principle technique that could give women and their oncologists more personalized information to help them choose options for treating breast cancer.
Are Changes to Current Colorectal Cancer Screening Guidelines Required?
Editorial suggests more research is needed to pinpoint age to end aggressive screening.
New Molecular Marker for Killer Cells
Cell marker enables prognosis about the course of infections.
Sniffing Out Cancer
Scientists have been exploring new ways to “smell” signs of cancer by analyzing what’s in patients’ breath.
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
2,600+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos