Natera publishes cfDNA data in Obstetrics & Gynecology

Natera (NTRA) announced that Obstetrics & Gynecology published the company’s clinical validation study on its cell-free DNA, or cfDNA, Fetal RhD noninvasive prenatal test. Natera’s study is the largest clinical validation of a fetal RhD test performed in the United States to date, with fetal RhD status confirmed via newborn serology in 655 RhD-negative pregnant patients. The study provides compelling scientific evidence on the ability of Natera’s Fetal RhD NIPT to identify fetal RhD status, and demonstrates its potential to assist patients and clinicians in the prevention and management of RhD alloimmunization. In addition, Natera’s next generation sequencing, or NGS-based Fetal RhD test can identify RHD pseudogene and other hybrid variants that are more commonly occurring in people of non-European ancestries. Key highlights of the study include: 356/356 fetuses were correctly identified as fetal RhD positive. Of the 297 RhD-negative fetuses, 295 were correctly identified as RhD-negative. Positive predictive value for the test was 99.4% and negative predictive value was greater than 99.9%. The study included a representative mix of race and ethnicities in the RhD-negative U.S. population.