BELGRADE,
Serbia,
Oct. 6, 2017/PRNewswire/ -- At the Trends in Medical Mycology (www.timm2017.org) conference,
Brukertoday introduces the new, CE-IVD markedFungiplex® Candidafast diagnostic assay, a multiplex real-time PCR test for the rapid identification of the most common pathogens associated with invasive candidiasis. The newFungiplex Candidaassay does not require any culture steps, and typically gives results in just 2-3 hours directly from patient blood, plasma or serum samples.
Brukeralso introduces the CE-IVD markedMICRONAUT®-AM(antimycotics) test plate for the automated or manual antifungal susceptibility testing (AFST) of yeasts from cultures.MICRONAUT®-AMis 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微生物学是由投资组合theMALDI 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'smicrobiology business, and re-inforce
Bruker'sadditional focus on rapid identification of invasive fungal diseases, followed by antifungal susceptibility testing.
With the previous launch of the CE-IVD markedFungiplex Aspergillusfast identification assay at ECCMID 2017,
Brukerannounced 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 newFungiplex Candida分析是一种多路实时PCR测试st 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. TheFungiplex Candidaassay 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 Candidadetects the main causative pathogens of IC:C. albicans,C. parapsilosis,C. tropicalis,C. dubliniensis, and differentiatesC. kruseiandC. glabrata.
TheFungiplex Candidaassay 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 newFungiplex Candidaassay: "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'sFungiplex Candidareal-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 ofCandidaPCR 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 theMICRONAUT™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). TheMICRONAUT-AMplate 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 theFungiplex CandidaandFungiplex Aspergillusreal-time PCR assays for the rapid detection of IFDs without culture, coupled with the introduction ofMICRONAUT-AMhigh-performance MIC-based antimycotic susceptibility products, complement the existingMALDI Biotyperproduct 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
BrukerMALDI Biotyper(MBT) Platform
TheMALDI Biotyperfamily 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. TheMALDI Biotyperuses 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 variousMALDI Biotypersolutions 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 theMALDI Biotyperhas 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 robustMALDI Biotyperrequires minimal sample preparation and offers low consumables cost. The products of theMALDI Biotyperfamily are available in a research-use-only (RUO) version, as the U.S.
FDA-clearedMALDI Biotyper CA System, or in an IVD-CE version according to EU directive EC/98/79. TheMALDI Biotyperalso has medical device registrations in numerous other countries. RUO versions of theMALDI Biotyperallow selected, high-value antimicrobial resistance tests.
About
Bruker Corporation(NASDAQ: BRKR)
For more than 55 years,
Bruker使三英洁具tists to make breakthrough discoveries and develop new applications that improve the quality of human life.
Bruker'shigh-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,
Brukeris 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.energie2point0.com
Investor Contact:
Miroslava Minkova
Head of Investor Relations
T: +1 (978) 663–3660, ext. 1479
E:miroslava.minkova@bruker.com
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Bruker Daltonics Division
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E:Wolfgang.Pusch@bruker.com
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