SAN JOSE, Calif.
March 18, 2013
/PRNewswire/ -- Ariosa Diagnostics, maker of the non-invasive Harmony™ Prenatal Test for risk assessment of common genetic conditions, has announced the expansion of the Harmony Prenatal Test to include the option of Y-chromosome analysis, which can provide information on fetal sex and aneuploidy as early as 10 weeks gestation.
The new "Harmony with Y test" will offer patients and their prenatal care providers with evaluation of the Y-chromosome through which fetal sex can be determined with greater than 99% accuracy. The test also assesses the risk of Y aneuploidy, such as XYY, which is due to an extra copy of chromosome Y. Y aneuploidy is estimated to be present in approximately 1 out of every 1,000 male newborns.
The new Y test follows the recent announcement by Ariosa Diagnostics of expanding the Harmony test to allow for both self and non-self IVF pregnancies. Approximately 5% of all pregnancies, or 300,000, in
the United States
result from IVF, and the Harmony test allows access to non-invasive prenatal testing for this pregnancy population.
"Our new test offering for Y chromosome analysis provides an option to those women undergoing the Harmony test," said
, MD, CEO of Ariosa. "XYY is more common than other autosomal trisomies, but has a varying clinical presentation and so proper counseling is needed prior to and following 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.