Ariosa completes clinical validation study for Harmony Prenatal Test

Ariosa Diagnostics (formerly Aria Diagnostics), a molecular diagnostics company, today announced the completion of its clinical validation study for the Harmony™ Prenatal Test. The multi-national study represents the largest clinical study performed to date for non-invasive prenatal detection of common fetal trisomies. The test utilizes a directed, non-invasive approach to cell-free DNA (cfDNA) analysis in maternal blood. Additionally, information about the company's proprietary biochemistry and algorithm platforms, which work together to efficiently analyze patient samples in order to provide individualized risk scores, will be presented at the 2012 American College of Medical Genetics (ACMG) Annual Clinical Genetics Meeting in Charlotte, N.C. 

"The completion of our validation study is an important milestone as we prepare to bring the Harmony Prenatal Test to market," said Ken Song, MD, chief executive officer at Ariosa Diagnostics. "The Harmony Prenatal Test's performance is the largest study to date using cell-free DNA technology and supports findings from our previous studies recently published in the American Journal of Obstetrics and Gynecology and Prenatal Diagnosis demonstrating highly accurate fetal trisomy detection."

At the upcoming ACMG meeting, additional data on Ariosa's technology will be shared during an oral platform presentation (Molecular session) titled, "Non-Invasive Fetal Aneuploidy Detection in Cell-free DNA from Maternal Blood Using Digital Analysis of Selected Regions (DANSR™) and the Fetal-fraction Optimized Risk of Trisomy Evaluation (FORTE™) Algorithm" on Thursday, March 29, 2012 from 8:30 to 8:45 a.m. at the Charlotte Convention Center.

Formerly known as Aria Diagnostics, the company has changed its name to Ariosa Diagnostics in an effort to further distinguish and differentiate itself from other companies and products.