Clinical Utility of the Harmony™ Prenatal Test in General Screening Population Highlighted During Fetal Medicine Foundation Course

SAN JOSE, California, Dec. 3, 2012 /PRNewswire/ -- Ariosa Diagnostics today announced that the Harmony™ Prenatal Test was featured during a presentation at the Fetal Medicine Foundation's "Advances in Fetal Medicine" course on Dec. 1, 2012 in London. Professor Kypros Nicolaides, M.D., director of the Fetal Medicine Centre (http://www.fetalmedicine.com/fmc/) and the Harris Birthright Research Centre for Fetal Medicine (http://www.harrisbirthright.org/), highlighted the center's clinical experience with the Harmony test as well as how to implement non-invasive prenatal testing (NIPT) with cell-free DNA (cfDNA) analysis in routine clinical practice for a general screening population. The center is currently offering the Harmony test to all pregnant women with a singleton pregnancy at 10 weeks of gestational age or later. More than 700 physicians and international experts from 70 countries in fetal medicine attended the course.

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"Cell-free DNA testing, such as that with the Harmony test, represents a brilliant new development and must be offered as a routine test," Nicolaides said. "Since introducing the Harmony test at the Fetal Medicine Centre, we have already seen the benefit of detecting cases of Down syndrome that would have been missed with conventional first-trimester combined screening. We have also avoided unnecessary invasive procedures that would otherwise have been performed due to false positive results from conventional screening."

The Harmony test analyzes cfDNA circulating in maternal blood and allows for a high level of accuracy in detecting fetal trisomies, such as trisomy 21, which causes Down syndrome. Nicolaides and his research team have produced four studies of the Harmony test (involving thousands of women) that have shown a greater than 99 percent detection rate for trisomy 21 and false positives of less than 0.1 percent.

The Fetal Medicine Centre became the first institution outside of North America to begin offering the Harmony test to patients in October 2012, and Nicolaides and his team are evaluating the clinical experiences of patients who undergo the testing and give birth. Ariosa plans to expand the availability of the Harmony test internationally.  The Harmony test involves a single, standard blood draw performed as early as 10 weeks' gestation.

About The Fetal Medicine Foundation (FMF)

The FMF (www.fetalmedicine.com) is a registered charity in the United Kingdom that aims to improve the health of pregnant women and their babies through research and training in fetal medicine.

The main source of income to the charity is a private clinic, the Fetal Medicine Centre (http://www.fetalmedicine.com/fmc/), which donates all profits to the FMF. Dr. Kypros Nicolaides provides all services to FMC and FMF free of charge.

In the last 16 years, the FMF has supported research and training in fetal medicine through grants to doctors (370 doctors from 50 countries) working at King's College Hospital for the development of safer techniques for prenatal diagnosis of fetal abnormalities, intrauterine fetal surgery and for the prediction and prevention of miscarriage, stillbirth, premature birth, preeclampsia and abnormal fetal growth.

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 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.