WellPoint Supports Cell-Free Fetal DNA-Based Prenatal Screening for Fetal Aneuploidy in Certain Pregnancies

SAN JOSE, Calif., Dec. 20, 2012 /PRNewswire/ -- Ariosa Diagnostics, provider of the Harmony™ Prenatal Test, today announced that WellPoint, which provides health benefits to more than 33 million people in the United States, has issued a medical policy update that deems cell-free fetal DNA-based prenatal screening for fetal aneuploidy (trisomies 13, 18, and 21) as medically necessary when certain clinical criteria are met. WellPoint supports cell-free DNA testing in women pregnant with a singleton fetus and considered at high risk for fetal aneuploidy (click here to read the full WellPoint policy.)

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WellPoint also noted the importance of offering such testing by adequately trained healthcare professionals in order to provide women with appropriate pre- and post-test counseling as well as the importance for women with screen positive results to be offered confirmatory, invasive prenatal diagnostic testing. Regarding different testing methods, WellPoint highlighted one of the shortcomings of massively parallel sequencing: it is not selective in the chromosomal origin of the sequenced DNA fragments. An alternative that overcomes this limitation is the employment of DANSR and FORTE, which are the principal assay and statistical components (respectively) of the Harmony Prenatal Test.

"We are encouraged by WellPoint's recognition of the clinical utility of non-invasive prenatal testing using cell-free DNA," said Dr. Ken Song, chief executive officer at Ariosa Diagnostics. "Our directed approach allows the Harmony Prenatal Test to be the most efficient cell-free DNA test as well as the most affordable non-invasive prenatal test at less than $1,000. We believe broad payer coverage of cell-free DNA testing will provide tremendous clinical benefit to patients and providers without increasing costs to the healthcare system."

About Ariosa Diagnostics

Ariosa Diagnostics, Inc. is a molecular diagnostics company committed to innovating together to improve patient care. The flagship product, the Harmony Prenatal Test, is a safe, highly accurate and affordable prenatal test for maternal and fetal health. Led by an experienced team, Ariosa is using its proprietary technology to perform a directed analysis of cell-free DNA in blood. The Harmony Prenatal Test equips pregnant women and their healthcare providers with reliable information to make decisions regarding their health, without creating unnecessary stress or anxiety.

The company began operations in 2010 and is headquartered in San Jose, Calif. For more information, visit www.ariosadx.com.

SOURCE Ariosa Diagnostics


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