-- cobas® DPX
assay increases safety of human plasma and plasma
products
PLEASANTON, California,
March 16, 2015 /PRNewswire/ -- Roche
(SIX: RO, ROG; OTCQX: RHHBY) announced today the commercial
availability of the cobas® DPX test for use on the
cobas® 6800/8800 Systems—expanding the menu of the newest
molecular diagnostic platforms from Roche with next generation
donor screening assays. The cobas® DPX test is a real-time
PCR duplex assay for parvovirus B19 (B19V) and hepatitis A virus
(HAV) in human plasma. Using nucleic acid amplification testing
(NAT) to detect these viral targets is an important step in
ensuring the safety of blood and plasma products.
"Roche is committed to providing the broadest coverage and most
efficient blood and plasma screening tests to ensure the highest
safety for patients," said Paul
Brown, Head of Roche Molecular Diagnostics. "Introducing
cobas® DPX to the cobas® 6800/8800 Systems is an
important step toward that goal, complementing our current donor
screening tests for the detection of HIV, HCV, HBV, WNV and
HEV."
By utilizing cobas® DPX, blood and plasma testing centers
are able to quickly identify and remove HAV-contaminated units,
while simultaneously minimizing the B19V burden in plasma pools.
Performing NAT with the cobas® DPX test enables testing
facilities to increase the processing efficiency of donations while
preserving high safety standards for plasma products used in
transfusions and other therapeutic treatments for patients.
The cobas® DPX assay and the cobas® 6800/8800
Systems are commercially available in markets that recognize
CE-Mark and are not currently available in the United States.
About Roche Blood and Plasma Screening
Roche is a leader in the global blood and plasma NAT screening
market, which is estimated at almost 800
million CHF. Nucleic acid-based tests enable earlier
detection of active viral infections than conventional antibody or
antigen assays. Roche's real-time PCR-based nucleic acid assays
have been used since 1998 to screen blood and plasma products.
Currently, more than 250 testing centers worldwide use Roche's
automated systems for blood and plasma screening.
Human plasma products are frequently used in the treatment of
chronic and hereditary diseases and disorders such as hemophilia
and primary immunodeficiency diseases. Plasma is also used to treat
patients who have suffered severe burns or trauma, and during major
surgery. To support therapeutic use, human plasma can be recovered
from blood donations or collected directly from donors, and
subsequently fractionated into its components, such as
immunoglobulins, albumin, and clotting factors.
About the cobas® 6800/8800 Systems
The cobas® 6800 and 8800 Systems are fully automated
solutions designed for blood donor screening, viral load
monitoring, women's health and microbiology testing. They are
available in medium and high throughput models, respectively. Based
on the Nobel-prize winning PCR technology, the systems are designed
to deliver increased automation and throughput with shorter time to
results, providing users with greater testing flexibility to
increase overall workflow efficiencies.
The systems provide up to 96 results in less than 3.5 hours, and
a total of 384 results for the cobas® 6800 and 960 results
for the cobas® 8800 in an 8 hours shift. Both systems allow
for mixed batching, making it possible for labs to perform up to
three tests in the same run with no pre-sorting required. The
systems also enable up to eight hours (cobas® 6800) and four
hours (cobas® 8800) of "work-away" time* with minimal user
interaction.
For more information about the systems, please visit
www.cobas68008800.com.
* May vary based on workflow demands
About Roche
Headquartered in Basel,
Switzerland, Roche is a leader in research-focused
healthcare with combined strengths in pharmaceuticals and
diagnostics. Roche is the world's largest biotech company, with
truly differentiated medicines in oncology, immunology, infectious
diseases, ophthalmology and neuroscience. Roche is also the world
leader in in vitro diagnostics and tissue-based cancer diagnostics,
and a frontrunner in diabetes management. Roche's personalised
healthcare strategy aims at providing medicines and diagnostics
that enable tangible improvements in the health, quality of life
and survival of patients. Founded in 1896, Roche has been making
important contributions to global health for more than a century.
Twenty-four medicines developed by Roche are included in the World
Health Organization Model Lists of Essential Medicines, among them
life-saving antibiotics, antimalarials and chemotherapy.
In 2014, the Roche Group employed 88,500 people worldwide,
invested 8.9 billion Swiss francs in
R&D and posted sales of 47.5 billion
Swiss francs. Genentech, in the
United States, is a wholly owned member of the Roche Group.
Roche is the majority shareholder in Chugai Pharmaceutical,
Japan. For more information,
please visit roche.com.
All trademarks used or mentioned in this release are protected
by law.
For media inquiries please contact:
Bob Purcell, Roche Molecular
Diagnostics
888-545-2443
Claudia Panozzo,
Austria
+43 1 277
87 360
Silvia Zucca, Italy
+39 039 2817
612
Francisco Aguilar-Alvarez,
Spain
+34 93583
4011
Eudes de Villiers,
France
+33 4 76 76
31 26
Banu Kutlu, Turkey
00902123060606
Harald Borrmann,
Switzerland
+41 41
799 6253
Kate Hoile,
UK
+44 1444 256591
Jan Schreiber, Germany
+49 621 759
5156
