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Bruker TB Test, PCR Platform Receives CE-IVD Mark

NEW YORK (GenomeWeb) – Bruker said today that its FluoroCycler XT PCR system and FluoroType MTBDR 2.0 Liquid Array assay for detecting tuberculosis and antibiotic resistance have received the CE-IVD mark.

According to Bruker, the PCR-based MTBDR test identifies pathogens directly from patient samples in three hours without the need for culturing. It can also detect more than 60 mutations in TB genes, which the company said can provide information on up to 522 patterns of antibiotic resistance, helping to guide therapy.

The test and platform are based on PCR technology that Bruker acquired access to when it purchased a majority share of Hain Lifescience, forming Bruker-Hain Diagnostics as a business unit within the company's Microbiology & Diagnostics division.

"With introduction of the FluoroType MTBDR 2.0 Liquid Array assay for in-depth tuberculosis testing on our innovative FluoroCycler XT platform, Bruker supports the multinational healthcare objective to improve diagnosis for improved personalized therapy of acute tuberculosis," David Hain, managing director of Bruker-Hain Diagnostics, said in a statement.

Jaime Esteban, a doctor in the department of clinical microbiology at the Autonomous University of Madrid, said his department plans to begin using the new test and platform.

"We will implement the new high-resolution FluoroType MTBDR 2.0 test together with the newly developed, high-performance optical FluoroCycler XT to improve our ability to diagnose acute TB with greater specificity and as quickly as possible," he said in a statement.