- MBT Sepsityper Kit US IVD enables rapid, specific detection
of many cases of bacteremia-induced sepsis to assist infectious
disease specialists in potentially life-saving decisions
- Used for MALDI Biotyper® (MBT) identification directly from
Positive Blood Cultures (PBC) with short time-to-result (TTR) of
less than 30 minutes
- US FDA clearance received in late December for diagnostic
use on MALDI Biotyper CA System with library of 425 organisms,
covering gram-positive and gram-negative bacteria, as well as
yeasts, e.g. Candida auris
Bruker Corporation (Nasdaq: BRKR)
today announce US FDA clearance and the US launch of the MBT
Sepsityper Kit US IVD for rapid microbial identification of
more than 425 microorganisms from positive blood cultures on the
MALDI Biotyper CA System.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20210104005112/en/
Figure 1: Ike Northern, Director of
Infectious Disease Testing and Immunology, CompuNet Clinical
Laboratory (Photo: Business Wire)
Dr. Wolfgang Pusch, Executive Vice President Microbiology &
Diagnostics at Bruker Daltonics, stated: “This represents an order
of magnitude increase in the number of microorganisms that can be
identified rapidly from positive blood cultures in suspected
bacterial or fungal sepsis cases compared to targeted PCR
detection. This could make the MBT Sepsityper Kit US IVD a
nearly universal, rapid sepsis identification solution for clinical
microbiology. We expect this affordable fast assay to benefit large
numbers of patients, as it comes at a fraction of the cost of
expensive syndromic panels with limited species coverage. Faster
identification can assist infectious disease physicians and
pharmacists in switching sepsis patients to appropriate antibiotics
or antifungals for local or hospital infection patterns, which
reduces costs, length of ICU stays and could save lives.”
The MBT Sepsityper Kit US IVD enables the rapid
identification of many microorganisms from positive blood culture
bottles. Harvested microorganisms are processed, and then
identified using the FDA-cleared MALDI Biotyper CA
System, with a reference library that covers 425 different
gram-negative and gram-positive bacterial species and groups, as
well as yeasts, including Candida auris, an emerging pathogen for
hospital-acquired candidiasis.
The MBT Sepsityper Kit US IVD workflow typically takes
less than 30 minutes from a positive blood culture bottle alert to
identification. It can save up to 24 hours in time-to-result (TTR)
for many identifications, versus additional agar plate culturing,
and a further 8–12 hours for biochemical identification after agar
plate culturing. The MBT Sepsityper Kit US IVD workflow does
not test for resistance or antibiotic susceptibility. It rapidly
identifies the microbial species once the blood culture system has
detected microbial growth.
Mr. Ike Northern, Director of Infectious Disease Testing and
Immunology at the CompuNet Clinical Laboratory in Dayton, Ohio,
explained: “I think a lot of laboratories are realizing that they
need to use MALDI-TOF MS technology for microbial identification.
Many are now making this investment when they recognize the
long-term patient and cost benefits. The MBT Sepsityper Kit US
IVD will be the next step for a lot of clinical microbiology
laboratories. Many are currently using multiplex PCR tests, but
once you have the MALDI Biotyper instrument, it is more
cost-effective to use the MBT Sepsityper Kit US IVD for fast
identification than PCR syndromic panels.” (*)
Rapid testing from positive blood cultures is gaining increasing
interest in the clinical microbiology community due to high
mortality and morbidity rates in sepsis and septic shock. Sepsis
impacts an estimated 30 million patients worldwide every year, many
of whom die or suffer permanent health issues. Survival rates can
be increased by rapid initiation of an appropriate antibiotic
therapy (http://www.worldsepsisday.org). Developed for use with
Bruker's U.S. FDA-cleared MALDI Biotyper CA System, the
MBT Sepsityper Kit US IVD is intended to simplify and speed
up identification of microorganisms directly from positive blood
cultures of sepsis patients.
Dr. Elisabeth C. Shearon, the Medical Director at Alverno
Laboratories in Hammond, Indiana, commented: “Rapid (MBT)
Sepsityper identification has become instrumental in terms
of our patient care. Especially in critically ill patients, the
improved turn-around-time allows disease specific treatment which
conserves health-care resources and, most importantly, improves
patient outcomes.” (*)
Currently, guidelines call for physicians to treat septic
patients quickly with broad-spectrum antibiotics with the goal of
switching to a more targeted therapy once the infecting organisms
have been identified and/or any antibiotic resistances have been
determined. The MBT Sepsityper Kit US IVD can improve this
process by providing rapid microbial identifications to help
clinical microbiologists, treating physicians, and patients
alike.
Dr. Steven D. Burdette, the Chief of Infectious Diseases at the
Miami Valley Hospital in Dayton, Ohio added: “The MBT
Sepsityper kit data has allowed us to adjust antibiotic therapy
according to our local antibiogram. This, at times, has allowed us
to narrow or stop certain antibiotic treatments while in other
cases, it has allowed us to escalate antibiotic coverage pending
sensitivity data. It has become a crucial tool for our
Antimicrobial Stewardship team.” (*)
* All quoted early adopters have self-validated the
research-use-only (RUO) version of the MBT Sepsityper kit
prior to FDA-clearance of the MBT Sepsityper Kit US IVD.
About the Bruker MALDI Biotyper® (MBT) Platform
The MALDI Biotyper® enables molecular identification of
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, as
well as the 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 software allow selected,
high-value antimicrobial resistance tests. The CE-IVD MBT
STAR®-Cepha kit now allows rapid, functional antibiotic resistance
testing against Cephalosporins, and the CE-IVD MBT STAR-Carba kit
is for fast Carbapenem-resistance testing.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210104005112/en/
Investor Contact: Miroslava Minkova Director of Investor
Relations and Corporate Development T: +1 (978) 663–3660, ext. 1479
E: investor.relations@bruker.com Contact for Media and
Customers: Philip Perry Bruker Daltonics T: +49-172-313-7216 E:
Philip.Perry@bruker.com
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