• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Cepheid, FIND, Rutgers collaborate on Xpert MTB/RIF test

Cepheid, FIND, Rutgers collaborate on Xpert MTB/RIF test

October 29, 2014
CenterWatch Staff

Cepheid, a Sunnyvale, Calif.-based molecular diagnostics company, FIND, a Switzerland-based international nonprofit organization and Rutgers New Jersey Medical School are collaborating to develop Xpert MTB/RIF Ultra, a next-generation test for Mycobacterium tuberculosis (TB) with increased sensitivity to aid in detection of patients with smear-negative TB, which often is associated with HIV co-infection. The collaboration also is receiving additional support from the National Institute of Allergy and Infectious Diseases at the NIH.

Technological innovations will leverage the power of Cepheid's GeneXpert System, currently the only platform for near-patient molecular TB testing. Over 7,500 GeneXpert Systems are deployed globally, including over 3,500 installed in 110 high burden developing countries (HBDC), making it the most widely distributed molecular platform in the world. Xpert MTB/RIF Ultra will run on existing six color GeneXpert Systems and is expected to be provided to HBDC markets at the same price as Xpert MTB/RIF.

"There is a pressing need for continued innovation in the field of TB diagnostics. The low sensitivity of smear microscopy limits its impact on TB control," said Dr. Catharina Boehme, CEO of FIND. "Xpert MTB/RIF Ultra has great potential to transform the way we diagnose the three million people who every year fail to receive TB testing or treatment. We are proud to partner with Cepheid in launching this highly sensitive and rapid test that will identify even more patients than its predecessor and make quality diagnostics a reality for people in the developing world."

"One reason that Xpert MTB/RIF has been heralded as a game-changer is its capability to detect individuals with infection. However, low levels of organisms are especially prominent in patients coinfected with HIV. These patients are commonly referred to as smear-negative because traditional microscopy does not detect their TB infection," said John Bishop, Cepheid's chairman and CEO. "An ability to identify these patients with an extremely high level of sensitivity with a single test represents a significant step forward in what already has been hailed worldwide as a revolutionary advance in the diagnosis of TB."

A primary reason current tests have difficulty identifying early-stage TB is that the target DNA in patient samples is below the levels of test detection. The Xpert MTB/RIF Ultra collaborative team plans to capitalize on Cepheid's unique, cartridge-based nested PCR amplification capability to amplify patient DNA samples to a level that can be more accurately detected. The current Xpert MTB/RIF test has a limit of detection (LOD) of 130cfu/ml.

New innovations, including a larger DNA reaction chamber in the cartridge, will enable Xpert MTB/RIF Ultra to bring the LOD down ten-fold, to approximately10cfu/ml (across all strains)—a level similar to or potentially better than liquid culture.

"The data clearly show that TB still is treated empirically in primary care settings because clinicians fear that a negative test result only means that the disease is not advanced enough to be detected. In addition, some serious cases of TB can be smear negative because a patient has a poor cough or is HIV positive," said David Alland, M.D., professor and chief, division of infectious diseases, Center for Emerging Pathogens at Rutgers New Jersey Medical School. "There is a huge need for an on-demand test that can accurately identify individuals with early-stage TB who currently test negative with other tests. Our preliminary results strongly suggest that Xpert MTB/RIF Ultra will not only eliminate the need for empiric therapy, it will cut TB treatment costs in half."

Cepheid also is developing an additional test to specifically call out extensively drug-resistant (XDR) tuberculosis. XDR TB is a form of multidrug-resistant tuberculosis (MDR TB) that is resistant to the most potent TB drugs—isoniazid, rifampin, aminoglycosides and any fluoroquinolone.

"When it comes to detecting TB, poor sensitivity for poor countries is not a winning combination," said David Persing, M.D., Ph.D., Cepheid's chief medical and technology officer. "Our collaboration with Dr. Alland and FIND to create Xpert MTB/RIF has truly helped revolutionize TB care around the world. Millions of people currently receive effective TB care each year—but missed cases are stalling gains. This new product will help to eliminate guesswork and deliver maximum medical impact in the management of TB cases worldwide."

Xpert MTB/RIF Ultra is expected to be available to the HBDC market in the first half of 2016.

Upcoming Events

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Revamp-360x240.png

    Califf Calls for Major Evidence Generation Revamp, Experts’ Opinions Differ

  • AskTheExpertsGreen-360x240.png

    Ask the Experts: Managing Investigational Products

  • SurveywBlueBackground-360x240.png

    Survey Outlines Site Challenges, Successes on Diversity

  • PatientCentricity-360x240.png

    Site Spotlight: DM Clinical Shows Patient Centricity Doesn’t Have to Break the Bank

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell or Share My Data

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing