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

May 2, 2016 – INDIANAPOLIS.  Roche 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.

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.

SOURCE Roche Diagnostics