Ariosa Diagnostics, San Jose, Calif, a molecular diagnostics company and provider of the Harmony™ Prenatal Test, reports 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.)
WellPoint also noted the importance of offering such testing by adequately trained health care professionals 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.
[Source: Ariosa Diagnostics]