In addition to the highly-regarded, established Hain GenoType™ MDx product portfolio, Hain has developed the novel Fluorocycler™ XT, an innovative real-time PCR system with an unprecedented temperature range and homogeneity for highest reproducibility and high-level multiplexing using Hain's proprietary, novel Liquid Array™ assay format. The first Liquid Array assay will be the Fluorotype MTBDR 2.0 for detecting the M. tuberculosis complex, including its drug resistances against rifampicin and isoniazid, with CE-IVD labeling expected after a test phase in selected early adopter laboratories. Additional Liquid Array assays for affordable mid- to high-throughput syndromic panel testing are planned.
David Hain, Managing Director of the renamed Bruker-Hain Diagnostics MDx business, said: "We expect the launch of our new Fluorotype MTBDR 2.0 Liquid Array tuberculosis assay in selected markets that accept the CE-IVD mark already in the fourth quarter of 2018. This assay will be a true multi-drug resistance (MDR) assay which further improves tuberculosis detection and classification to give infectious disease doctors a valuable tool to improve public health."
Professor Robin M. Warren at the DST-NRF Centre of Excellence for Biomedical Tuberculosis Research and SAMRC Centre for Tuberculosis Research at Stellenbosch University, South Africa, stated: "We have already been successfully using the Hain GenoType portfolio and Fluorotype MTBDR assay for mycobacteria analysis. Hain is a proven mycobacteria expert, and we are excited about the Bruker-Hain Diagnostics innovation pipeline that will further improve TB testing with more differentiated diagnostic information."
Dr. Catharina Boehme, CEO of the Foundation for Innovative New Diagnostics (FIND) in Geneva, Switzerland, added: "Drug-resistant TB is a major public health concern in many countries. While drug susceptibility testing for rifampicin is increasing, we are still a long way from the universal access called for by WHO in the 'End TB' strategy. Expanded rapid tests such as those offered by Bruker-Hain Diagnostics are necessary to identify isoniazid-monoresistance and enable individualized patient therapy."