First wave of laboratories in Europe will conduct Harmony Prenatal Test in
their own labs
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) technology and maker of the
Harmony Prenatal Test, today announced that it has granted licenses
to laboratories so that they can develop, validate, and conduct
NIPT using the same technology that Ariosa has provided to over
500,000 women globally to date.
"Through these license agreements, Ariosa now enables
laboratories to locally perform NIPT with the same technology we
use in our CLIA laboratory in California to perform the Harmony Prenatal
Test," said Ken Song, CEO of Ariosa
Diagnostics. "They represent a significant step in reaching our
goal to offer the broadest access to the world's leading and most
validated NIPT to pregnant women worldwide."
Features of the Harmony Prenatal Test technology include rapid
turnaround time, fetal fraction measurement and reporting,
scalability, and individualized patient risk score. Ariosa is
pursuing CE-IVD certification for the Harmony Prenatal Test.
About the Harmony Test
The Harmony Prenatal Test is a blood test for pregnant women
that can be used as early as 10 weeks into pregnancy. By evaluating
cell-free DNA found in maternal blood, including accurate
measurement of the fetal fraction of DNA, the test assesses the
risk of Trisomy 21 (Down syndrome) in the fetus. It has been
validated to CLIA requirements by a robust clinical data set and
supported by clinical studies in more than 22,000 women of all ages
and risk categories*. It is available in more than 90 countries and
has been used to guide clinical care in over 500,000 pregnancies
worldwide.
*Data have not been submitted to or evaluated by Federal
regulatory agencies and the test is not for sale as an In Vitro
Diagnostic (IVD) in the US or the EU.
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.
All trademarks used or mentioned in this release are protected by
law.
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SOURCE Roche Sequencing
