Benzinga | Nov 19, 2021 09:01AM EST

Natera Reports Its Panorama SMART Study Results Accepted For Publication By American Journal Of Obstetrics, Gynecology

-- Natera, Inc. (NASDAQ:NTRA), a leader in personalized genetic testing and diagnostics, 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 largest 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.1-2

* 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.1

"We're proud to have sponsored the SMART study, the largest prospective NIPT validation study ever performed, which focused on a general population cohort and used the gold standard of diagnostic testing for genetic truth," said Ramesh Hariharan, General Manager of Natera's Women's Health business. "This study demonstrates the excellent performance of SNP-based NIPT in a real-world setting, giving practicing physicians around the world greater confidence in screening their pregnant patients for common trisomies."

The SMART data described herein was previously presented at SMFM 2021.