Natera, Inc. announced that Obstetrics & Gynecology, also known as The Green Journal, published the company’s clinical validation study on its cell-free DNA (cfDNA) Fetal RhD noninvasive prenatal test (Fetal RhD NIPT). This publication provides robust scientific evidence for the test's performance.
The study represents the largest clinical validation of a fetal RhD test performed in the United States to date, involving 655 RhD-negative pregnant patients with fetal RhD status confirmed via newborn serology. The test demonstrated excellent performance metrics, including a sensitivity of 100% and a specificity of 99.3%.
Natera’s next-generation sequencing (NGS)-based Fetal RhD test can identify RHD pseudogene and other hybrid variants, which are more common in people of non-European ancestries. This test has the potential to assist patients and clinicians in preventing and managing RhD alloimmunization, aligning with recent guidance from the American College of Obstetricians and Gynecologists (ACOG).
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