Bruker announces improved assay for TB diagnostics in novel Liquid Array™ format for improved multiplexing
-- Expanded FluoroType™ MTBDR 2.0 Liquid Array molecular
assay with CE-IVD mark provides highly differentiated
tuberculosis (TB) detection and antibiotic resistance
testing
-- Novel FluoroCycler™ XT PCR system
with CE-IVD mark enables new Liquid Array format
NEHREN, Germany – March 22, 2019 – In time for the
World Tuberculosis (TB) Day 2019 on Sunday, March 24th (www.who.int/campaigns/world-tb-day/world-tb-day-2019), Bruker today announced the launch of an important further
innovation in the field of tuberculosis diagnostics.
According
to the World Health Organization (WHO), TB is among the most
dangerous infectious diseases worldwide, ranking alongside
HIV/AIDS (https://www.who.int/tb/en/) as a cause for death. One of the targets of the United
Nations’ Sustainable Development Goals for 2030 is to end
the tuberculosis epidemic (https://www.un.org/pga/73/event/fight-to-end-tuberculosis/), 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 resistant to the first-line drugs
isoniazid (INH) and rifampicin (RIF), and XDR-TB in addition has
developed resistance to fluoroquinolone and the injectable
compounds used. The rapid diagnosis and appropriate treatment of
both MDR-TB and XDR-TB is therefore essential to prevent
significant morbidity, mortality and further transmission of the
disease.
In recent years an increased spectrum of anti-mycobacterial resistance, and therefore an increased number of MDR and XDR cases has been observed. Conventional antibiotic susceptibility testing (AST) methods for TB can take an extremely long time to yield results, require significant laboratory infrastructure and training, and are potentially biohazardous. As a result, there is still under-diagnosis and a gap between acute TB cases and TB notifications.
The new PCR-based FluoroType MTBDR 2.0 assay
identifies tuberculosis pathogens, as well as several
important antibiotic resistance characteristics in only three
hours. The novel assay detects TB pathogens directly from
patient samples, without the need for any culture. In
addition, it can be used to detect MDR-TB, i.e. resistance
against rifampicin and isoniazid, the two most important first
line TB drugs. This novel TB test relies on the innovative
Bruker-Hain Liquid Array technology to analyze a multitude of
mutations in the associated TB resistance genes.
The
new FluoroCycler XT is a novel,
high-performance thermal cycler and optical reader that
enables the Liquid Array assay technology. The
FluoroType MTBDR 2.0 assay can detect more than 60
mutations in the TB genes, leading up to 522 resistance
patterns with relevant information to guide therapy. This
level of genetic specificity normally can only be achieved
with sequencing.
Dr. Jaime Esteban from the Depto. Microbiología Clínica at the Universidad Autónoma de Madrid stated: “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.”
The FluoroCycler XT PCR system and the FluoroType MTBDR 2.0 assay were CE-IVD registered in January 2019. With their combined launch, the fight against TB has a new tool for advanced testing to provide superior diagnostic information.
David Hain, Managing Director of Bruker-Hain Diagnostics, said: “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.”
About Bruker Corporation (Nasdaq: BRKR)
Bruker
is enabling scientists to make breakthrough discoveries and
develop new applications that improve the quality of human
life. Bruker’s high-performance scientific instruments
and high-value analytical and diagnostic solutions enable
scientists to explore life and materials at molecular,
cellular and microscopic levels. In close cooperation with our
customers, Bruker is enabling innovation, improved
productivity and customer success in life science molecular
research, in applied and pharma applications, in microscopy
and nanoanalysis, and in industrial applications, as well as
in cell biology, preclinical imaging, clinical phenomics and
proteomics research and clinical microbiology. For more
information, please visit: www.bruker.com.
About Bruker-Hain Diagnostics
Bruker-Hain Diagnostics was formed after the recent
acquisition of a majority share of the Hain Lifescience GmbH
as a Business Unit for Molecular Diagnostics (MDx) products in
Bruker´s Microbiology & Diagnostics business. Hain
Lifescience GmbH is the legal manufacturer of the
FluoroCycler XT and the MTBDR 2.0 assay. For more
information, please visit, www.hain-lifescience.de.
Source:
Bruker Corporation
