SAN JOSE, Calif., June 11, 2015 /PRNewswire/ -- Roche (SIX:
RO, ROG; OTCQX:RHHBY). Ariosa Diagnostics, Inc., a global leader in
non-invasive prenatal testing (NIPT), today announced its
proprietary FORTE™ software has received the CE mark (Conformite
Europeenne). As one of Europe's
major assurances of quality, the CE marking is a significant
achievement toward the continued expansion of the Harmony Prenatal
Test in Europe and globally.
"FORTE software is a cornerstone of the Harmony Prenatal Test,
which has been one of the most trusted brands in NIPT among
patients and OB/GYNs to determine the risk of trisomies in more
than 500,000 patients in the world," said Ariosa Chief Operating
Officer Dave Mullarkey. "Achieving
this regulatory milestone validates our efforts and allows Ariosa
to partner with labs throughout Europe and license the FORTE software required
for technology transfers."
The FORTE software is used to enable analysis of cell-free DNA
(cfDNA) isolated from plasma from a pregnant woman, in order to
assess the risk of fetal chromosome 21, 18, and 13 trisomy, the
risk of fetal chromosome X and Y aneuploidy, and fetal sex. As a
result, the FORTE software, in conjunction with other clinical
indicators and risk factors, can provide a more accurate assessment
of fetal chromosome conditions than other statistical
methods.1 The FORTE software will reside on a server at
licensed labs to allow processing of patient data in the country of
testing.
Receipt of the CE mark for the FORTE software is supportive of
the quality of the design and development of the FORTE
software.
1 Ashoor G et al., Am J Obstet Gynecol. 2012
Apr;206(4):322.e1-5.
About Ariosa Diagnostics
Ariosa Diagnostics, Inc. is a
leading global molecular diagnostics company committed to improving
overall patient care by developing and delivering innovative,
affordable, and widely-accessible testing services through their
CLIA laboratory. Tests are fully validated to CLIA requirements by
rigorous and comprehensive methodologies to ensure health care
practitioners and patients can be confident in the test's
performance. Ariosa has developed leading-edge technologies to
perform a directed analysis of cell-free DNA in blood. Ariosa is
located in San Jose, California
and was acquired by Roche in 2015. For more information, visit
www.ariosadx.com
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-eight 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 www.roche.com.
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SOURCE Roche Sequencing