San Jose, Calif., [March 13, 2014] – Ariosa Diagnostics, Inc., maker of the Harmony™ Prenatal Test, announced today that it has tested over 45,000 pregnant women in the fourth quarter of 2013 continuing the rapid adoption of the Harmony test as a safe, highly accurate and affordable alternative to current prenatal screening tests. Ariosa has received patient samples from over 50 countries worldwide.
Ariosa also announced that effective January 1, 2014, its Harmony test has a Category 1 MAAA CPT code (81507). This CPT code is unique to the Harmony test and should facilitate reimbursement from third party payers moving forward.
The NEXT Study (Non-invasive EXamination of Triosmy), a direct head-to-head comparison of current first trimester screening against the Harmony test in the general pregnancy population, is the largest prospective blinded study of a non-invasive prenatal screening test in the general pregnancy population. Top line results from the study will be presented as oral platform presentations at two academic meetings this month: the 2014 American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting in Nashville, TN on March 28th at 5:15 pm and at the Society for Gynecologic Investigation Annual Scientific meeting in Florence, Italy on March 29th at 12:45 pm.
The Harmony test is a non-invasive blood test for pregnant women that can be used as early as 10 weeks into pregnancy. By evaluating cell-free DNA from the fetus found in maternal circulation, the test can assess the risk of Down syndrome with greater than 99% accuracy. Current prenatal screening tests return false positive results as often as 5% of the time. The Harmony test is much more accurate, returning false positive rates of less than 0.1% for Down syndrome, potentially lowering the frequency of invasive procedures such as amniocentesis.