SAN JOSE, Calif., Nov. 13, 2013 /PRNewswire/ -- Ariosa Diagnostics, Inc., maker of the Harmony™ Prenatal Test, announced today that it has tested over 40,000 pregnant women in the third quarter of 2013 and over 150,000 women since commercial launch last year, thereby solidifying Ariosa's position as a significant provider of non-invasive prenatal testing (NIPT).
The Harmony test is a blood test for pregnant women that can be used as early as 10 weeks in 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 and provide fetal sex information. Compared to current prenatal screening tests that have up to a 20% error rate, the Harmony test with its much higher accuracy, represents a significant advance in prenatal testing.
The Harmony test was first launched nationally in the United States in May 2012 via collaboration with the Laboratory Corporation of America. Since then, Ariosa has expanded its global footprint securing numerous relationships with key laboratories, hospitals, and clinics in over 50 countries across six continents.
"The strong demand for our test is driven by the clear value proposition it provides over conventional prenatal screening tests," says Ken Song, MD, CEO of Ariosa Diagnostics. "In each country that we have launched, we have seen brisk uptake. We are pleased with the initial adoption of our test and look forward to broadening access."
In the United States, NIPT testing is primarily targeted to women designated as "high" risk based on maternal age or other risk factors. Current insurance coverage is largely limited to this subset of pregnant women. Ariosa, which began its operations in 2010, set the goal of providing more accurate tests to all pregnant women and has invested heavily in clinical research to supports its mission. In addition to multiple peer-reviewed publications that demonstrate the utility of the Harmony test in a general screening population, Ariosa is also leading an international multi-center study comparing the Harmony test to conventional screening. This trial, which has been named the NEXT Study (Non-invasive EXamination of Triosmy), has completed enrollment of over 18,900 subjects and is expected to have results available in the first half of 2014. The Harmony test is also being studied as part of a Genome Canada funded trial.
"We are committed to provide the best care to all pregnant women, not just a subset," says Thomas Musci, MD, CMO of Ariosa Diagnostics. "Our introduction of non-invasive prenatal testing into routine practice is backed by our proprietary technology and high-quality automated lab processes that ensure each patient sample is handled with care."
About Ariosa Diagnostics
Ariosa Diagnostics, Inc. is a molecular diagnostics company committed to innovating together to improve patient care. The flagship product, the HarmonyTM 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 HarmonyTM 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.
SOURCE Ariosa Diagnostics