Ariosa Diagnostics, Inc. Release: Harmony™ Prenatal Test Demonstrates Clinical Utility in a General Screening Population

SAN JOSE, CA--(Marketwired - June 10, 2013) - The Harris Birthright Centre for Fetal Medicine today released results from a clinical implementation study (http://onlinelibrary.wiley.com/doi/10.1002/uog.12504/full) on the use of Ariosa Diagnostics’ Harmony™ Prenatal Test in a general screening population. The test uses cell-free DNA (cfDNA) testing from maternal blood to assess fetal genetic conditions such as trisomy 21, which causes Down syndrome. The study looked at the feasibility, reliability and utility of performing the test in a general screening population, not just for high-risk pregnancies, and demonstrated that cfDNA testing can be safely incorporated into routine prenatal care to reduce unnecessary invasive testing, like amniocentesis.

Professor Kypros Nicolaides, a renowned maternal fetal medicine specialist and one of the authors of the study, said, “The results of our study demonstrate the value of cfDNA testing in routine screening for trisomies. This technology represents one of the greatest advances in prenatal screening and can help guide better management for any pregnant woman.”

Routine Testing

The protocol used in the study, offered to all women presenting for prenatal screening, demonstrates an effective implementation of the Harmony test into standard prenatal care.

The study of 1,005 women demonstrated that cfDNA testing has significantly lower false positive rates compared to current screening methods. The cfDNA testing method identified trisomies 21, 18, and 13 with a false positive rate of only 0.1%, compared to 3.4% from conventional screening. Non-invasive cfDNA testing substantially reduced the rate of referrals for invasive testing procedures, which carry an inherent risk of miscarriage. These findings support the Harmony test as a safe and accurate first step in screening for any pregnant women.

Benefit to Prenatal Care

The manner in which Harmony Test results are reported -- either with a high or low-risk result -- allow parents to decide whether or not to undergo additional procedures depending on their level of risk. In cases where a fetus may be at high risk for trisomy, physicians should provide parents with extra time for decision-making and preparation for future treatment and planning.

Methodology

The data for this study was derived from clinical implementation of cfDNA testing in screening for trisomies 21, 18 and 13 during the 10th gestational week in women with singleton pregnancies attending The Fetal Medicine Centre in London, UK, between October 2012 and April 2013. A two-stage approach to screening was used, with two visits, one at 10 weeks and another at 12 weeks.

About Ariosa Diagnostics

Ariosa Diagnostics, Inc. is a molecular diagnostics company committed to innovating together to improve patient care. The flagship product, the Harmony Prenatal Test, is a safe, highly accurate and affordable prenatal test for maternal and fetal health. Led by an experienced team, Ariosa is using its proprietary technology to perform a directed analysis of cell-free DNA in blood. The Harmony Prenatal Test equips pregnant women and their healthcare providers with reliable information to make decisions regarding their health, without creating unnecessary stress or anxiety.

The company began operations in 2010 and is headquartered in San Jose, Calif. For more information, visit www.ariosadx.com. Follow us on Twitter @HarmonyPrenatal and on Facebook at Harmony Prenatal for Healthy Pregnancy.