FRANKLIN LAKES, N.J. and
EYSINS, Switzerland, Feb. 20, 2018 /PRNewswire/ -- BD (Becton,
Dickinson and Company) (NYSE: BDX), a leading global medical
technology company, today announced the commercial availability of
the CE-IVD marked PAXgene® Blood ccfDNA tube within the
European Economic Area and Switzerland (Western
Europe). The plastic blood collection tube, which includes a
proprietary sample stabilization additive and BD
Vacutainer® Hemogard™ technology to help protect
healthcare worker safety, was designed to ensure accurate and
reproducible results in molecular diagnostic testing applications
using circulating cell-free DNA (ccfDNA), such as cancer and
non-invasive prenatal tests. The product was developed by
PreAnalytiX GmbH, a joint venture between BD and QIAGEN.
Cells, including fetal cells, tumor cells, or cells from
transplanted organs, release DNA into the blood stream. This DNA
can be analyzed using PCR or next-generation sequencing to
understand genetic characteristics of a developing fetus, a cancer
tumor, or a transplanted organ from a blood draw. Molecular
diagnostic tests using ccfDNA enable clinicians to gain actionable
biological insights without a tissue biopsy or similar invasive
test.
The PAXgene Blood ccfDNA tube provides a solution for clinical
laboratories to stabilize samples when the sample cannot be
processed on the same day it was collected. Where standard EDTA
tubes require processing within hours before cells die and release
genomic DNA into blood plasma (thus changing the native ccfDNA
profile), the PAXgene tube has a unique stabilization chemistry
that enables collection and processing to occur days apart,
addressing a critical logistical hurdle for reference labs offering
molecular testing outside of the hospital setting.
"Many molecular diagnostic companies, particularly in the cancer
space, are developing new tests for monitoring and screening
patients. They need a safe, clinically acceptable system for blood
collection and ccfDNA processing that is capable of stabilizing a
sample so that ccfDNA extraction can occur after the sample is
transferred to another location, something that's not possible with
EDTA tubes," said Frank Augello,
general manager, PreAnalytiX GmbH. "This product will help
molecular diagnostics companies in Western Europe offering ccfDNA based tests to
grow their markets more quickly and ultimately help more patients
access leading edge care."
"Reducing the potential for preanalytical errors is critical to
ensuring the accuracy of molecular diagnostic tests," said Uwe
Oelmueller, Ph.D., vice president, head of MDx development sample
technologies for QIAGEN, GmbH. "We are confident that the CE-IVD
marked version of the PAXgene Blood ccfDNA tube will provide robust
safety, and reliable and reproducible ccfDNA-based test results,
helping to expand access to molecular diagnostic testing in
Western Europe."
Since 2016, PreAnalytiX has marketed a research use only (RUO)
version of the PAXgene Blood ccfDNA tube together with the
QIAsymphony® PAXgene® Blood ccfDNA kit as a
fully integrated and standardized system covering all preanalytical
workflow steps from blood collection, stabilization, transport,
storage and isolation of high quality ccfDNA. The RUO tube version
has the same format and stabilization chemistry as the new
CE-marked version. The RUO version of the tube will be discontinued
as customers adopt the CE-IVD. For more information, visit
https://www.preanalytix.com/products/blood/ccfDNA/paxgene-blood-ccfdna-tube-ivd-use.
About PreAnalytiX
PreAnalytiX, a joint venture between BD and QIAGEN, develops,
manufactures and sells integrated and standardized systems for
sample collection, stabilization and purification of high-quality
RNA, microRNA and DNA from human blood, bone marrow, or tissue
specimens. The company serves healthcare institutions, academic
researchers, clinical laboratories and the pharmaceutical industry
with a broad array of manual and automated products.
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 65,000 employees have a passion and
commitment to help improve patient outcomes, improve the safety and
efficiency of clinicians' care delivery process, enable laboratory
scientists to better diagnose 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. In 2017, BD welcomed C. R. Bard and its products into
the BD family. For more information on BD, please visit bd.com.
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the
leading global provider of Sample to Insight solutions that enable
customers to gain valuable molecular insights from samples
containing the building blocks of life. Our sample technologies
isolate and process DNA, RNA and proteins from blood, tissue and
other materials. Assay technologies make these biomolecules visible
and ready for analysis. Bioinformatics software and knowledge bases
interpret data to report relevant, actionable insights. Automation
solutions tie these together in seamless and cost-effective
workflows. QIAGEN provides solutions to more than 500,000 customers
around the world in Molecular Diagnostics (human healthcare),
Applied Testing (forensics, veterinary testing and food safety),
Pharma (pharma and biotech companies) and Academia (life sciences
research). As of September 30, 2017,
QIAGEN employed approximately 4,600 people in over 35 locations
worldwide. Further information can be found at
http://www.qiagen.com.
Forward Looking Statements
This press release contains certain forward-looking statements
(as defined under Federal securities laws) regarding PAXgene Blood
ccfDNA tube. Forward looking statements may be identified by use of
words such as "will", "intend", "plan", "believe", "expect" or
other words of similar meaning. All such statements are based upon
the current expectations of BD and involve a number of business
risks and uncertainties that could cause actual results to differ
materially from anticipated results described, implied or projected
in any forward-looking statement, including, without limitation,
regulatory changes, competition, rapid or unexpected changes in
technologies, and the ability to gain market. We do not
intend to update any forward-looking statements to reflect events
or circumstances after the date hereof except as required by
applicable laws or regulations.
Contacts:
|
|
Gwen
Gordon
|
Monique N.
Dolecki
|
BD Public
Relations
|
BD Investor
Relations
|
858.812.3724
|
201.847.5378
|
gwen.gordon@bd.com
|
monique_dolecki@bd.com
|
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SOURCE BD (Becton, Dickinson and Company)