New England Journal of Medicine publishes findings of largest
non-invasive prenatal testing (NIPT) study involving more than
18,500 expectant mothers
SAN JOSE, California,
April 2, 2015 /PRNewswire/ -- Roche
(SIX: RO, ROG; OTCQX: RHHBY). Results from the largest clinical
trial to date, comparing non-invasive prenatal testing (NIPT) using
the HarmonyTM Prenatal Test with conventional first
trimester combined screening (FTS) in a general pregnancy
population1, have been published online in The
New England Journal of Medicine (NEJM). The NEXT (Non-Invasive
Examination of Trisomy) Study demonstrates statistically
significant superiority of the HarmonyTM Prenatal Test
over FTS for accurately assessing the risk of Trisomy 21, which
causes Down syndrome. The study, comprised of more than 18,500
expectant mothers, was sponsored by Ariosa Diagnostics, Inc.
(Ariosa). Ariosa was acquired by Roche in January 2015.
"This landmark study supports the use of NIPT as a first line
screening option for any pregnant woman, regardless of whether the
patient is low, average, or high risk. No study to date has been
large enough to assess the performance of NIPT, compared to
conventional screening, in the general pregnancy population," said
Ronald Wapner, MD, co-Principal
Investigator of the study and professor of obstetrics and
gynecology at Columbia University
Medical Center. "But the NEXT Study has shown high accuracy with
NIPT regardless of maternal age or risk status."
The NEXT Study enrolled pregnant women during the first
trimester with an average gestational age of 12.5 weeks. The study
was statistically designed for both sensitivity and specificity,
with all patients receiving both NIPT and FTS in a blinded fashion.
Each subject was followed through pregnancy and newborn outcomes
were obtained. The Harmony test's false positive rate at 0.06% was
more than 90 times lower than the FTS false positive rate of 5.4%.
The Harmony test correctly identified 100% of Trisomy 21 cases
compared to 79% with FTS. In a sub-analysis of over 11,000 low risk
only pregnancies (maternal age < 35 years), the Harmony test
identified all Trisomy 21 cases with a false positive rate of
0.05%, demonstrating equivalent performance to that of the Harmony
test in the total study population.
"By identifying cases of Trisomy 21 much more accurately, the
Harmony test significantly lowers the risk of false positive
results, which in turn may reduce the need for invasive testing,"
said Thomas Musci, MD, Chief Medical Officer at Ariosa. "The
results of this study are a step toward improving prenatal care and
reaffirm our mission to offer highly accurate, non-invasive
prenatal testing to all women who choose screening, regardless of
age or risk."
1Women in the general pregnancy population were
included regardless of age or other risk factors.
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
400,000 pregnancies worldwide.
* Data have not been submitted to or evaluated by 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 personalized 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 www.roche.com.
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