American Journal of Obstetrics and Gynecology Accepts Natera, Inc.'s First Manuscript from the Landmark Smart Study for Publication
November 19, 2021 at 09:00 am EST
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Natera, Inc. announced that the first manuscript from the landmark SMART study has been accepted for publication by the American Journal of Obstetrics and Gynecology (AJOG). This publication describes the performance of the Panorama non-invasive prenatal test (NIPT) for common trisomies. SMART is the prospective NIPT study ever performed, and the only one to collect genetic confirmation of outcomes on all patients in the analysis. The study rigorously tested the performance of Panorama, confirming its market-leading performance in a real-world setting, and extending Panorama's position as the most thoroughly studied NIPT in the market. The study also included the validation of a new deep-learning, artificial intelligence-based algorithm for Panorama called Panorama AI, which utilizes information from over 2 million cfDNA tests performed by Natera. The SMART study enrolled more than 20,000 patients over five years at 21 U.S. and international sites. All patients received Panorama as part of routine clinical care. The key results in this initial publication include: Panorama demonstrated 99% sensitivity and >99.5% specificity for trisomy 21 in a real-world setting, consistent with previously published studies; and Panorama AI maintained high sensitivity, detected additional cases of common aneuploidies, and significantly lowered the no-call rate to 1.5%, and to 0.6% after one redraw.
Natera, Inc. is a diagnostics company, which is focused on the development and commercialization of molecular testing services, applying its technology in the fields of womenâs health, oncology and organ health. Its cell-free deoxyribonucleic acid (cfDNA) technology combines its molecular assays, which reliably measure many informative regions across the genome from samples as small as a single cell. The Company's product offerings include Panorama Non-Invasive Prenatal Test (NIPT), Vistara, Horizon Carrier Screening, Spectrum Preimplantation Genetics, Anora Miscarriage Test, Empower, and Prospera. The Company also offers Constellation, a cloud-based software platform that enables laboratory customers to gain access through the cloud to the Companyâs algorithms and bioinformatics in order to validate and launch tests based on the Companyâs technology. Its NIPT screens for chromosomal abnormalities of a fetus as well as in twin pregnancies, typically with a blood draw from the mother.
NATERA, INC. 
