US insurance coverage for Harmony Prenatal Test from Roche expands to 200 million covered lives

02 MAY 16

Indianapolis, IN

In-network status for non-invasive prenatal test now includes four largest national private health plans and Medi-Cal

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that insurance coverage for its Harmony™ Prenatal Test in the U.S. has been expanded to include in-network status with the four largest national private insurance health plans, increasing total coverage to approximately 200 million covered lives. The non-invasive prenatal test(NIPT), a service provided by Ariosa Diagnostics, is also accessible to patients covered by Medicaid in multiple states across the country, now including Medi-Cal in California, making the Harmony test one of the most widely covered NIPT tests in the U.S.

“The continued shift toward in-network coverage for the Harmony test is helping to make non-invasive prenatal testing available to more women,” said Dave Mullarkey, chief operating officer for Ariosa Diagnostics and lifecycle leader, NIPT. “We’re continuing to work with both public and private insurers to ensure that this highly accurate testing is affordable and easily accessible to pregnant women, regardless of their income, age or risk.”

The Harmony Prenatal Test analyzes DNA in a sample of the mother’s blood to predict the risk of Down syndrome (trisomy 21) and certain other genetic conditions. Compared to traditional prenatal screening tests, it offers significantly higher accuracy. A study by Norton et al. in the April 2015 New England Journal of Medicine indicated that fewer than 1 in 1,000 results with the Harmony test were incorrectly reported as high risk for Down syndrome, versus up to 1 in 20 with traditional tests.

About the Harmony Test

Developed by Ariosa Diagnostics, a CLIA-certified and CAP-accredited laboratory, the Harmony Prenatal 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 found in the mother’s blood, the test measures a woman's risk of carrying a baby with a chromosomal condition such as Trisomy 13, 18 or 21 (Down syndrome). It has been validated with the largest clinical data set of any prenatal cell-free DNA test, making it the most broadly studied cell-free DNA test. The Harmony test is available in more than 90 countries and has been used to guide clinical care in over 350,000 pregnancies worldwide.

As with other lab-developed tests, the Harmony test has not been cleared or approved by the FDA and is not available for sale as an IVD in the US. Non-invasive prenatal testing (NIPT) based on cell-free DNA analysis is not diagnostic; results should be confirmed by diagnostic testing.

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 its CLIA laboratory. Tests are fully validated to CLIA requirements by rigorous and comprehensive methodologies to ensure healthcare 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,

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalized healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognized as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry seven years in a row by the Dow Jones Sustainability Indices.

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2015 employed more than 91,700 people worldwide. In 2015, Roche invested CHF 9.3 billion in R&D and posted sales of CHF 48.1 billion. 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 or

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For further information, please contact:

Todd Siesky
Senior Director, Communications
Roche Diagnostics Corporation
Indianapolis, IN
(317) 521-3966


Mike Weist
Communications Business Partner, Molecular Diagnostics
Indianapolis, IN
(317) 521-3112