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The statement clearly emphasizes NIPS as a screening, and not diagnostic, test. It goes on to highlight the advantages of higher detection rates and lower false positives rates associated with NIPS versus maternal serum screening, and it underscored the importance of first trimester ultrasound regardless of screening modality. ACMG recommends both pre-test and post-test counseling to inform women about NIPS tests in regards to benefits and limitations. As a screening test, NIPS can lead to both false positive and false negative results.
NIPS with the Harmony™ Prenatal Test has been studied in more than 6,000 women to date across multiple studies. Ariosa shares ACMG's view that NIPS is a safe and effective prenatal testing option for pregnant women and that it should be responsibly introduced into clinical practice.
"ACMG's statement provides ongoing support of non-invasive prenatal screening with cell-free DNA as a major clinical advance," said
Ken Song, CEO of Ariosa Diagnostics. "Our commitment to responsible introduction of this screening technology will help women manage the health of their pregnancy and fetus.
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.