SAN JOSE, Calif. and LONDON, Jan. 28, 2014 /PRNewswire/ -- A team of clinical researchers from The Harris Birthright Centre for Fetal Medicine is leading a study to evaluate the implementation of cell-free DNA testing using the Harmony™ Prenatal Test in the UK screening population of 700,000 women per year. While the Harmony test is available throughout the UK, it is being offered only through private clinics where women pay directly for the test themselves. The Harmony test evaluates cell-free fetal DNA found in the maternal blood. The test has been shown in clinical studies and in clinical practice to have greater than 99% accuracy in identifying Down syndrome cases.
The NHS currently funds and supports prenatal screening of Down syndrome for the entire pregnancy population using the first trimester combined test, which involves serum protein analysis in conjunction with specialized ultrasound to measure nuchal translucency. A future goal is to have the NHS incorporate cell-free DNA testing into the national screening program for Down syndrome.
The clinical study, which started in early October 2013, is targeted to enroll at least 25,000 pregnant women. Over 1,700 women have been enrolled to date in the study. All women will first undergo the first trimester combined test, and depending on the result, a subset will be offered the Harmony test. By incorporating the Harmony test into the screening algorithm, it is expected that the number of Down syndrome cases identified will increase and the number of false positive screenings will decrease.
Professor Kypros Nicolaides, a world-renowned maternal-fetal medicine specialist who is leading the study said, "The benefits of cell-free DNA testing are quite clear as we have seen this first hand via offering the test in the Fetal Medicine Centre since last year. It is important for this technology to be made available to all pregnant women, and we expect our study will help demonstrate a path forward for the NHS to adopt cell-free DNA testing."
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.
SOURCE Ariosa Diagnostics, Inc.