BELGRADE, Serbia, Oct. 6, 2017 /PRNewswire/ -- At the Trends
in Medical Mycology (www.timm2017.org) conference, Bruker today
introduces the new, CE-IVD marked Fungiplex® Candida
fast diagnostic assay, a multiplex real-time PCR test for the rapid
identification of the most common pathogens associated with
invasive candidiasis. The new Fungiplex Candida
assay does not require any culture steps, and typically gives
results in just 2-3 hours directly from patient blood, plasma or
serum samples.
Bruker also introduces the CE-IVD marked
MICRONAUT®-AM (antimycotics) test plate for the
automated or manual antifungal susceptibility testing (AFST) of
yeasts from cultures. MICRONAUT®-AM is from the
product range of recently acquired MERLIN Diagnostika GmbH, a
leader in speciality susceptibility testing products across a range
of human and veterinary application areas.
The Bruker microbiology portfolio is led by the
MALDI Biotyper (MBT) platform for fast
proteomic fingerprinting, a market-leading family of products
providing rapid, broad-based molecular identification of
microorganisms like bacteria, yeasts and fungi from cultures.
Both new IFD tests further expand Bruker's microbiology business,
and re-inforce Bruker's additional focus on rapid identification of
invasive fungal diseases, followed by antifungal susceptibility
testing.
With the previous launch of the CE-IVD marked Fungiplex
Aspergillus fast identification assay at ECCMID 2017,
Bruker announced a new focus on rapid detection of fungal
infections in at-risk patients, especially the immuno-compromised,
allowing the development of effective treatment strategies to
deliver improved patient outcomes. Such IFD diagnostic tools
have the additional benefits of reducing prophylactic antifungal
drug treatments, reducing the likelihood of antifungal resistance
and bringing down the overall cost of care for at-risk
patients.
The new Fungiplex Candida assay is a multiplex
real-time PCR test for the most common pathogens associated with
invasive candidiasis (IC), a major cause of morbidity and mortality
in health care environments. The sensitivity of blood culture for
diagnosing IC is low, typically reported at 50%, and is coupled
with slow turnaround times of 2-3 days. Delayed diagnosis and
delays to the initiation of appropriate treatment are associated
with high mortality and extended hospital stays. The
Fungiplex Candida assay enables the early
identification of Candida infection without the need for blood
culture and is validated against DNA extracted from whole blood,
serum and plasma. Fungiplex Candida detects the
main causative pathogens of IC: C. albicans, C.
parapsilosis, C. tropicalis, C. dubliniensis, and
differentiates C. krusei and C. glabrata.
The Fungiplex Candida assay reports the
identification results in less than 2 hours from DNA extraction and
displays excellent clinical performance, in a user friendly format
compatible with existing laboratory equipment. This assay delivers
the potential to aid earlier diagnosis, reduce hospital spend and
improve patient outcomes.
Dr. Lewis White, Principal
Clinical Scientist at NPHS Microbiology Cardiff, commented on the
new Fungiplex Candida assay: "Fungal diseases such as
invasive candidiasis pose an extremely serious healthcare risk to
immunosuppressed patients, especially within the intensive care
unit. Current diagnostic methods, including culture, struggle due
to low sensitivity. Expensive prophylactic and empiric drug use is
common, whereas PCR, as a key component of combined biomarker
surveillance strategies, has the potential to prevent the overuse
of unnecessary antifungals and allows the targeted use of
antifungal drugs. Bruker's Fungiplex Candida
real-time PCR assay, when combined with appropriate recommendations
on DNA extraction, provides a standardised approach that displays
excellent analytical performance and clinical sensitivity and
specificity, with the potential to improve the diagnosis and
treatment of at-risk patients. With the standardization of
Candida PCR previously lacking, this new commercial option
provides users with a validated and quality controlled alternative
to be used in combination with serological tests."
The principle of the MICRONAUT™ system for
specialty antimicrobial susceptibility testing is the phenotypic
detection of microbial growth inhibition in the presence of
antibiotics. Its microdilution procedure is a standardized,
globally accepted reference method for the determination of minimal
inhibitory concentrations (MICs). The
MICRONAUT-AM plate allows for the antifungal
susceptibility testing (AFST) of nine antimycotics (including
anidulafungin, caspofungin and posaconazol) in up to eleven
concentrations, and provides a standardized workflow for analysis
with visual or photometric interpretation.
Dr. David Eustace, Head of IFD
Business Unit at Bruker Daltonics, added: "The combination of the
Fungiplex Candida and Fungiplex
Aspergillus real-time PCR assays for the rapid detection of
IFDs without culture, coupled with the introduction of
MICRONAUT-AM high-performance MIC-based antimycotic
susceptibility products, complement the existing MALDI
Biotyper product family in the field of invasive fungal
disease testing. This expanding IFD portfolio has the
capability of meeting a wide range of customer needs, delivering
high quality solutions to improve patient outcomes at every stage
of the IFD treatment pathway."
About the Bruker MALDI Biotyper (MBT) Platform
The MALDI Biotyper family of systems enables molecular
identification of microorganisms like bacteria, yeasts and
fungi. Classification and identification of microorganisms is
achieved reliably and quickly using proteomic fingerprinting by
high-throughput MALDI-TOF mass spectrometry. The MALDI
Biotyper uses a molecular approach based on specific proteomic
fingerprints from bacterial strains. Many published studies
have highlighted the greater accuracy and lower cost offered, as
well as typically much faster time-to-result (TTR).
Applications of various MALDI Biotyper solutions include
clinical routine microbial identification, environmental and
pharmaceutical analysis, taxonomical research, food and consumer
product safety and quality control, as well as marine microbiology.
In many European and international laboratories the MALDI
Biotyper has replaced classical biochemical testing for
bacterial identification in the past few years due to the accuracy,
speed, extensive species coverage, ease of use and cost
effectiveness of the system. Traditional biochemical
techniques detect different metabolic properties of microorganisms,
can take many hours or even days for completion, and they often
lack specificity.
The robust MALDI Biotyper requires minimal sample
preparation and offers low consumables cost. The products of
the MALDI Biotyper family are available in a
research-use-only (RUO) version, as the U.S. FDA-cleared MALDI
Biotyper CA System, or in an IVD-CE version according to EU
directive EC/98/79. The MALDI Biotyper also has
medical device registrations in numerous other countries. RUO
versions of the MALDI Biotyper allow selected, high-value
antimicrobial resistance tests.
About Bruker Corporation (NASDAQ: BRKR)
For more than 55 years, Bruker has enabled 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,
productivity and customer success in life science molecular
research, in applied and pharma applications, in microscopy,
nano-analysis and industrial applications, as well as in cell
biology, preclinical imaging, clinical phenomics and proteomics
research, clinical microbiology and molecular pathology
research. For more information, please visit:
www.bruker.com
Investor
Contact:
Miroslava
Minkova
Head of Investor
Relations
T: +1 (978) 663–3660, ext.
1479
E: miroslava.minkova@bruker.com
Contact for Media and Customers:
Dr. Wolfgang Pusch
Bruker Daltonics Division
Tel: +49-421-2205-270
E: Wolfgang.Pusch@bruker.com
MALDI Biotyper® and MBT STAR® are
registered trademarks of Bruker Daltonik GmbH in the European Union
and other regions.
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