SAN CARLOS, Calif., Aug. 18, 2020 /PRNewswire/ -- Natera, Inc. (NASDAQ:NTRA), a leader in non-invasive prenatal testing, announced a joint guideline released yesterday by the American College of Obstetrics and Gynecology (ACOG) and Society of Maternal Fetal Medicine (SMFM), regarding the use of cell-free DNA (cfDNA). The new guideline supports aneuploidy screening in all patients, regardless of maternal age or baseline risk, and highlights, for the first time, that cfDNA-based testing can be performed in twin pregnancies.
"The updated ACOG/SMFM guideline recommends offering screening options to all patients regardless of maternal age or prior risk. It also concludes that, based on Level A evidence, NIPT is the most sensitive and specific screening test available for common fetal aneuploidies. We believe that this change is an important precursor to broader coverage and utilization of NIPT," said Dr. Russ Jelsema, Maternal Fetal Medicine Specialist and Sr. Medical Director of Women's Health at Natera. "The guideline also highlights unique aspects of SNP-based NIPT technology, including detection of triploidy, use as early as 9 weeks, and the ability to assess zygosity and individual fetal fraction when testing twins."
"Natera's market leadership is driven by its strength of evidence and clinical differentiation documented in 22 peer-reviewed publications including over 1.3 million patients," said Sheetal Parmar, Genetic Counselor and VP of Medical Affairs at Natera. Natera has also sponsored the SMART (SNP-based Microdeletion and Aneuploidy Registry Trial) study, the largest prospective NIPT study to date. This real-world study across 21 global sites, with confirmatory diagnostic microarray on each sample, including both high and average risk patients, is expected to further support the statements in the guideline. In addition, the study, with publications planned in 2021, will report on screening for common microdeletions which represents additional opportunity for Natera.