San Jose, Calif., July 24, 2012 – Ariosa Diagnostics, Inc., a molecular diagnostics company, announced today the completion of the first clinical study to evaluate non-invasive prenatal testing (NIPT) using cell-free DNA (cfDNA) in a general population of pregnant women. The patients of this study were from a single large obstetrical practice over a specified period of time and represent an average-risk population for that center. The study’s significance is that it evaluates the HarmonyTM Prenatal Test in a population primarily containing pregnant women at low risk for chromosomal abnormalities. Detailed results from this blinded, independent study are being prepared for submission to a peer-reviewed journal.
“The completion of this average-risk study demonstrates our ongoing commitment to validate the effectiveness of the Harmony Prenatal Test in pregnant women,” said Ken Song, MD, chief executive officer for Ariosa Diagnostics. “We look forward to collaborating with all stakeholders in the healthcare system to ensure broad access to NIPT, which we believe will lead to better prenatal care.”
This new study from Ariosa adds to the robust clinical study portfolio supporting the Harmony test, which to date, includes four major publications. The first study published in January 2012 in Prenatal Diagnosis was a proof-of-concept study on Ariosa’s directed cfDNA approach to accurately detect fetal trisomies. Following this, two studies – a blinded study in a high-risk population of pregnant women and an independent study in a similar high-risk population exclusively from the first trimester – were published jointly in the American Journal of Obstetrics and Gynecology. More recently, the largest NIPT cohort study comprising both high- risk and average-risk women in either their first or second trimester was published in the American Journal of Obstetrics and Gynecology. The completion of the current general population study further supports the clinical benefit of NIPT to be used broadly.
“These studies clearly demonstrate the accuracy of the Harmony test,” said Tom Musci, MD, maternal fetal medicine specialist and vice president of medical affairs and clinical development for Ariosa Diagnostics. “NIPT provides a much needed option for prenatal testing of common fetal trisomies, and physicians should be empowered with this technology to determine how best to manage their pregnant patients.”
Ariosa is also pleased to announce that its laboratory has received accreditation from the College of American Pathologists (CAP). CAP accreditation is based on rigorous standards and is internationally recognized as a program that helps laboratories achieve the highest standards of excellence to positively impact patient care.