510(k) Clearance of BD COR™ MX Instrument Elevates
Standard of Care for Sexually Transmitted Infections
FRANKLIN
LAKES, N.J., May 12, 2022
/PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a
leading global medical technology company, today announced the U.S.
launch of its new, fully automated, high-throughput infectious
disease molecular diagnostics platform.
With 510(k) clearance from the U.S. Food and Drug Administration
(FDA), the new BD COR™ MX instrument is a new analytic instrument
option for the BD COR™ System. The first test available on the new
system is the BD CTGCTV2 molecular assay, a single test that
detects the three most prevalent non-viral sexually transmitted
infections (STIs) — Chlamydia trachomatis (CT), Neisseria
gonorrhoeae (GC) and Trichomonas vaginalis (TV). These
three STIs can include a range of negative patient outcomes, from
pregnancy complications to increased risk of HIV.
The BD COR™ MX/PX System integrates and automates the complete
molecular laboratory workflow, from sample processing to diagnostic
test result for large, high-throughput labs. The BD COR™ System
eliminates the need to sort specimens enabling the lab tech to have
very little interaction with the specimen freeing up time for other
critical lab processes.
Together, the BD COR™ MX/PX System allows 1,700 specimens to be
loaded, with onboard capacity for reagents and samples that provide
more than seven hours of unimpeded system processing. The system is
capable of delivering up to 1,000 sample results in 24 hours,
eliminating multiple manual interactions per shift that were
traditionally required. It also offers dual DNA targets for CT and
GC detection together in the same sample and assay, which can help
reduce false positives.
"Even before COVID-19, clinicians and laboratory technicians
were faced with increasing workloads and patient needs, and now
those challenges have been amplified significantly by the ongoing
staffing shortages and further increased workloads caused by the
pandemic," said Brooke Story,
president of Integrated Diagnostic Solutions for BD. "By automating
labor-intensive and mundane error-prone processes, the BD COR™
MX/PX System allows lab technicians and clinicians to focus on
higher value work."
Collection options for the BD CTGCTV2 assay include
self-collection (in clinical setting), vaginal/endocervical swab,
urine (both male and female) and liquid-based cytology.
The BD COR™ System also includes a GX instrument, which
leverages the BD Onclarity™ HPV Assay with extended genotyping to
screen for HPV infections. The GX instrument coupled with the
availability in the U.S. of the MX instrument, which was CE marked
in 2021, expands the use of the platform and automates testing for
a growing list of high-demand, essential assays for women's health
and STI testing. Additional assays for the MX instrument are in
development and are planned beyond women's health and STI
testing.
The BD COR™ System is fully automated, modular, and scalable
instrument, designed to address multiple needs within laboratories
to handle expanding molecular testing volumes. The BD COR™ System
is particularly well-suited for laboratories requiring high
throughput testing because of innovative automation, minimizing
staff interaction by maximizing laboratory workflow
efficiencies.
About BD
BD is one of the largest global medical technology companies in
the world and is advancing the world of health by improving medical
discovery, diagnostics and the delivery of care. The company
supports the heroes on the frontlines of health care by developing
innovative technology, services and solutions that help advance
both clinical therapy for patients and clinical process for health
care providers. BD and its 75,000 employees have a passion and
commitment to help enhance the safety and efficiency of clinicians'
care delivery process, enable laboratory scientists to accurately
detect disease and advance researchers' capabilities to develop the
next generation of diagnostics and therapeutics. BD has a presence
in virtually every country and partners with organizations around
the world to address some of the most challenging global health
issues. By working in close collaboration with customers, BD can
help enhance outcomes, lower costs, increase efficiencies, improve
safety and expand access to health care. For more information on
BD, please visit bd.com or connect with us on LinkedIn at
www.linkedin.com/company/bd1/ and Twitter @BDandCo.
Contacts:
Media:
Mela Sera,
APR
|
Investors:
Francesca
DeMartino
|
BD Public
Relations
|
SVP, Head of Investor
Relations
|
443.824.8012
|
201.847.5743
|
mela.sera@bd.com
|
francesca.demartino@bd.com
|
View original content to download
multimedia:https://www.prnewswire.com/news-releases/bd-launches-fully-automated-high-throughput-infectious-disease-molecular-diagnostic-platform-in-the-us-301545834.html
SOURCE BD (Becton, Dickinson and Company)