San Jose, Calif., March 18, 2013 – 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 Ken Song, 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.”