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.
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."
Panorama reveals a baby's risk for severe genetic disorders as early as nine weeks into pregnancy. The test uses a unique single-nucleotide polymorphism (SNP)-based technology to analyze fetal/placental DNA obtained through a blood draw from the mother. It is the only commercially available test that differentiates between maternal and fetal DNA to assess the risk of aneuploidies. The test also screens twin pregnancies for zygosity and fetal sex of each baby, and identifies risk for more genetic conditions in twin pregnancies than any other NIPT. Panorama is one of several genetic screening tests from Natera designed to help families on the path to parenthood. Natera has published 23 papers, studying over 1.3 million patients, since the launch of Panorama – the largest body of evidence in the space today. Panorama has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.
Natera is a pioneer and global leader in cell-free DNA testing from a simple blood draw. The mission of the company is to change the management of disease worldwide with a focus on women's health, oncology, and organ health. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, California and Austin, Texas. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. Follow Natera on LinkedIn.
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical or other studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.
Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350 Media: Paul Greenland, VP of Corporate Marketing, Natera, Inc., [email protected]
Dar P, et al. Multicenter prospective study of SNP-based cfDNA screening for aneuploidy with genetic confirmation in 18,496 pregnancies [abstract]. Society for Maternal-Fetal Medicine. Virtual Meeting. Oral Presentation 62. Jan. 25-30, 2021.
Dar P, et al. Multicenter prospective study of SNP-based cfDNA for 22q11.2 deletion in 18,289 pregnancies with genetic confirmation [abstract]. Society for Maternal-Fetal Medicine. Virtual Meeting. Oral Presentation 67. Jan. 25-30, 2021.
Norton M, et al. Perinatal and genetic outcomes associated with no call cfDNA results in 18,496 pregnancies [abstract]. Society for Maternal-Fetal Medicine. Virtual Meeting. Plenary Presentation 5. Jan. 25-30, 2021.