San Jose, Calif., November 1, 2013 – Ariosa Diagnostics, Inc., maker of the Harmony™ Prenatal Test, announced today that it has been selected as a key provider of non-invasive prenatal testing (NIPT) services in the majority of the 28 comprehensive Prenatal Diagnosis Centers (PDC) throughout the State of California. The Harmony test, which is the most widely used NIPT globally, is being offered to pregnant women as part of the California Prenatal Screening Program at no additional cost, subject to the program requirements.
Currently, the California Prenatal Screening Program offers traditional serum and neural tube defect screening to the general population of pregnant women. Patients found to be screen positive for possible chromosome conditions (such as Down syndrome or trisomy 18), or have an increased nuchal translucency measurement, are referred for other services that include genetic counseling, ultrasound, amniocentesis and chorionic villus sampling (CVS). Given its increased sensitivity and specificity, the State has now introduced NIPT as another option in evaluating patients who have an increased risk for chromosome conditions based on their serum screening results.
The Harmony test has the most published data of any NIPT available for pregnant women of any age, fetal gestational age and risk-profile. Published in over 13 peer-reviewed studies, involving thousands of patients, the test has demonstrated greater than 99% accuracy for Down syndrome with a less than 0.1% false positive rate, thereby diminishing the potential for women to unnecessarily proceed to invasive diagnostic procedures that may result in pregnancy complications in an otherwise normal fetus.