Xpert® MTB/XDR
Simplifying TB drug susceptibility testing utilizing increased multiplexing capability with 10 color GeneXpert® technology
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The Need

Drug-resistant tuberculosis (TB) continues to be a global public health crisis
The End TB Strategy calls for universal access to drug susceptibility testing (DST).1 Yet only 39% of the estimated 448,000 multidrug resistant (MDR) incident cases in 2018 had been notified, and only 32% of those were enrolled in treatment.2 In 2017, among the MDR or rifampicin resistant (RR) TB cases only 50% were tested for resistance to fluoroquinolones and second-line injectable agents.3
At the same time, new evidence and guidance on the treatment of drug-resistant tuberculosis is being issued by WHO, advocating for the use of new oral drug regimens which require DST.4,5 Likewise, the increasing incidence of isoniazid-monoresistance among TB cases calls for reliable molecular diagnostic tests.6
However, so far, the only molecular tests recommended by WHO for molecular DST require a high bacterial load in the sample, specialized laboratory equipment, well-trained personnel2 and have a long time to result.
(1) WHO End TB Strategy, https://www.who.int/tb/post2015_strategy/en/ (2) WHO. Global Tuberculosis Report 2019. www.who.int/tb/publications/global_report
(3) WHO. Global Tuberculosis Report 2018. https://apps.who.int/iris/bitstream/handle/10665/274453/9789241565646-eng.pdf
(4) WHO. Rapid Communication: Key changes to treatment of multidrug- and rifampicin-resistant tuberculosis. August 2018. https://www.who.int/tb/publications/2018/WHO_RapidCommunicationMDRTB.pdf
(5) Sulis G et al., Isoniazid-resistant tuberculosis: A problem we can no longer ignore. PLoS Med. 2020 Jan 21;17(1):e1003023.
(6) WHO. High-priority target product profiles for new tuberculosis diagnostics: report of a consensus meeting. 2014

The Solution

The world needs rapid molecular DST that can detect resistance to the most common first and second line drugs with an approach that doesn't require sophisticated skills or laboratory equipment.6
The ideal test would support health care providers with the same quality of test results at the level of a reference lab as well as at decentralized healthcare facilities, to link more patients to appropriate care.
Xpert MTB/XDR allows fast molecular DST. Combined with the frontline test Xpert MTB/RIF Ultra, Xpert MTB/XDR sets new standards by detecting mutations associated with resistance towards isoniazid (INH), fluoroquinolones (FLQ), second-line injectable drug (SLID) (amikacin, kanamycin, capreomycin) and ethionamide (ETH) in a single test.
  • Faster time to result for molecular DST
  • Results in <90 minutes
  • Same easy-to-use process as Xpert MTB/RIF Ultra
  • Run on existing GeneXpert® platforms equipped with 10-color modules
(6) WHO. High-priority target product profiles for new tuberculosis diagnostics: report of a consensus meeting. 2014

The Impact

The effective management of TB and MDR-TB relies upon early diagnosis including universal DST and effective treatment of resistant TB strains. Fast molecular DST followed by the fast initiation of appropriate treatment regimens has benefits for both the individual, as well as the community where the patient lives. To avoid diagnostic delays, molecular DST should be obtained for fast detection of mutations associated with resistance while waiting for a phenotypic DST result to adjust treatment if necessary.
Patient Impact
  • Fast and accurate DST results when needed most
  • Potential to test and initiate treatment for drug-resistant TB in a single visit
  • Adjustment of treatment as early as possible to reduce income loss and improve patient outcome
Potential TB Program Impact
  • Accurate and fast test results for drug-resistant TB
  • More patients linked to appropriate treatment regimens faster
  • Leverage GeneXpert® capacity for further drug-resistance testing
(8) Xpert MTB-XDR ENGLISH Package Insert 302-3514 Rev A