Companion diagnostics allow for rapid and reliable testing for fluoroquinolone, second-line injectable drugs and isoniazid resistance
Geneva, Switzerland – 11 October 2017 – One of the targets of the United Nations’ Sustainable Development Goals for 2030 is to end the tuberculosis (TB) epidemic, which demands a global effort to tackle the rise of multi-drug resistant TB (MDR TB) and extensively drug-resistant TB (XDR-TB). MDR-TB is TB that is resistant to the first-line drugs isoniazid (INH) and rifampicin (RIF), and XDR-TB is MDR-TB that has developed additional resistance to a fluoroquinolone and any of the injectable compounds used.
The rapid diagnosis and appropriate treatment of both MDR and XDR-TB is essential to prevent significant morbidity, mortality and further transmission of disease. For treatment of MDR-TB, the World Health Organization (WHO) recently endorsed a 9-month short-course treatment regimen, replacing conventional 18-24 month regimens. Fluoroquinolones and second-line injectables are key components of the MDR-TB 9-month regimen, and it is important to rule-out resistance to these compounds prior to treating patients with the short-course treatment.
Conventional drug susceptibility testing (DST) methods take several months to yield results, require significant laboratory infrastructure and training, and are potentially biohazardous. Cepheid’s Xpert MTB/RIF assay is a WHO-endorsed integrated, automated, cartridge-based system for MDR-TB diagnosis using the GeneXpert instrument platform. Hain’s new Fluorotype test system is an automated, fast centralized platform that, with the MTBDR assay, can detect resistance to both rifampicin and INH. It is currently undergoing trialing to support a submission for WHO review.
FIND is supporting the development of tests on both of these platforms to broaden the portfolio for second-line resistance detection (and INH for Cepheid). The expansion of rapid DST to second-line drugs has become a development and implementation priority, as it will enable further scale-up of short-course regimens recommended by WHO.
“It is important to consider innovative diagnostics to enable the roll-out of new regimens and combat drug resistant TB,” said Catharina Boehme, CEO of FIND. “We are pleased to support Cepheid and Hain, proven partners in the global health diagnostic field.”
These products are expected to become available for use in low and middle-income countries in two to three years, meeting the performance characteristics defined by the high priority target product profiles for new TB diagnostics and following review by WHO.
This work is supported by UK Aid from the UK government, Australian Government, Ministry of Education and Research (BMBF) Germany and the Netherlands Enterprise Agency.
FIND was established in 2003 as a global non-profit dedicated to accelerating the development, evaluation and delivery of high-quality, affordable diagnostic tests for poverty-related diseases, now including malaria, tuberculosis, HIV/AIDS, sleeping sickness, hepatitis C, leishmaniasis, Chagas disease, Buruli ulcer, non-malarial fever and diseases with outbreak potential, such as Ebola. FIND has partnered in the delivery of 20 new diagnostic tools and created an enabling environment for numerous others through the provision of specimen banks, reagent development and better market visibility. FIND also supports better access to new diagnostics through implementation, quality assurance and lab strengthening work. FIND has nearly 200 partners globally, including research institutes and laboratories, health ministries and national disease control programmes, commercial partners, bilateral and multilateral organizations, especially WHO, and clinical trial sites.
About Hain Lifescience GmbH
Hain Lifescience GmbH is medium-sized company based in Nehren in the South of Germany. The company was founded by the brothers David and Tobias Hain in 1986 and develops, manufactures and distributes molecular genetic diagnostic test systems and instruments for laboratories worldwide. With these tests systems definite statements can be made, for example about the presence of hereditary diseases or the presence of pathogenic bacteria which can cause serious diseases such as tuberculosis or hospital-acquired infections. More than 100 employees work at the headquarter in Nehren. Furthermore, the company has subsidiaries in Spain, France and United Kingdom, South and West Africa as well as a worldwide distribution network. For more information on Hain Lifescience, please visit http://www.hain-lifescience.de/en/.
Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company’s solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit http://www.cepheid.com.