Benzinga | Feb 3, 2021 09:10AM EST

Natera Highlights Presentation Of Results From SMART Study At MFM 41st Annual Pregnancy Meeting

SAN CARLOS, Calif., Feb. 3, 2021 /PRNewswire/ -- Natera, Inc. (NASDAQ:NTRA), a pioneer and global leader in cfDNA testing, presented key results from its SMART study at the SMFM 41st Annual Pregnancy Meeting.1-3 The SMART study is the largest prospective, multi-site study ever performed in NIPT, and the only to collect genetic confirmation of outcomes on the vast majority of subjects. The study rigorously tested the performance of the current version of Panorama, confirming its market-leading performance in a real-world setting and extending Panorama's position as the most thoroughly studied NIPT on the market. The study also includes 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.

Key findings:

* SMART is the largest prospective NIPT study ever performed, and the only study to collect genetic truth in a vast majority of subjects.

* Panorama robustly demonstrated 99% sensitivity and >99.95% specificity for trisomy 21 in a real-world setting.

* Panorama AI maintained high sensitivity, detected additional aneuploidies, and significantly lowered the no call rate to 1.5%, and to 0.6% after one redraw.

* Panorama uniquely identified patients at significantly increased risk of adverse perinatal outcomes, including increased rates of preterm birth and preeclampsia, providing actionable information from Panorama "no calls" to guide clinical management.

"Our market leadership has been driven by our focus on offering the most accurate NIPT test. We are excited to announce Panorama AI, which extends Natera's technology leadership, delivers reliable results for more patients, and provides more clinically useful information for those with very low levels of cell-free DNA," said Matthew Rabinowitz, co-founder of Natera and Executive Chairman of the Board. "We are happy with the response to the groundbreaking results presented at SMFM. The performance will help drive increased utilization of Panorama, at a time when many physicians are implementing average risk NIPT, as we predicted."

"Panorama's performance and unique capabilities have been documented in 23 peer-reviewed publications including over 1.2 million patients -- more than any other NIPT. With SMART, we have demonstrated robust performance, in a large prospective study across 21 global sites on 3 continents, which is unparalleled in the industry," said Sheetal Parmar, VP of Medical Affairs and Head of Clinical Services at Natera. "We are proud of our commitment to innovation and the opportunity to positively impact many more pregnancies as we look ahead."