Ariosa Diagnostics Shows Continued Growth of the Harmony™ Prenatal Test in
Fourth Quarter of 2013 and Obtains CPT Code
SAN JOSE, Calif., March 13, 2014
SAN JOSE, Calif., March 13, 2014 /PRNewswire/ --Ariosa Diagnostics, Inc.,
maker of the Harmony™ Prenatal Test, announced today that it has tested over
45,000 pregnant women in the fourth quarter of 2013 continuingthe rapid
adoption of the Harmony test as a safe, highly accurate and affordable
alternative to current prenatal screening tests.Ariosa has received patient
samples from over 50 countries worldwide.
Ariosa Diagnostics Logo.
Ariosa also announced that effective January 1, 2014, its Harmony test has a
Category 1 MAAA CPT code (81507). This CPT code is unique to the Harmony test
and should facilitate reimbursement from third party payers moving forward.
The NEXT Study (Non-invasive EXamination of Triosmy), a direct head-to-head
comparison of current first trimester screening against the Harmony test in
the general pregnancy population, is the largest prospective blinded study of
a non-invasive prenatal screening test in the general pregnancy population.
Top line results from the study will be presented as oral platform
presentations at two academic meetings this month: the 2014 American College
of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting in
Nashville, TN on March 28^th at 5:15 pm and at the Society for Gynecologic
Investigation Annual Scientific meeting in Florence, Italy on March 29^th at
The Harmony test is a non-invasive blood test for pregnant women that can be
used as early as 10 weeks into pregnancy. By evaluating cell-free DNA from
the fetus found in maternal circulation, the test can assess the risk of Down
syndrome with greater than 99% accuracy. Current prenatal screening tests
return false positive results as often as 5% of the time. The Harmony test is
much more accurate, returning false positive rates of less than 0.1% for Down
syndrome, potentially lowering the frequency of invasive procedures such as
About Ariosa Diagnostics
Ariosa Diagnostics, Inc. is a molecular diagnostics company committed to
innovating together to improve patient care. Our flagship product, the
Harmony^TM Prenatal Test, is a safe, highly accurate and affordable prenatal
test for maternal and fetal health. Led by an experienced team, we use our
proprietary technology to perform a directed analysis of cell-free DNA in
blood. The Harmony^TM Prenatal Test equips pregnant women and their healthcare
providers with reliable information to make decisions regarding their health,
without creating unnecessary stress or anxiety.
We began commercial operations in 2010 and are headquartered in San Jose,
Calif. For more information, visitwww.ariosadx.com. Follow us on Twitter
@HarmonyPrenatal and on Facebook at Harmony Prenatal for Healthy Pregnancy.
SOURCE Ariosa Diagnostics, Inc.
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