AUSTIN, Texas, Nov. 19, 2021 /PRNewswire/ -- 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."
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 leader in personalized genetic testing and diagnostics, transforming how we make critical health care decisions. Our genetic and diagnostic tests help clinicians and their patients protect their health and enable earlier and more targeted interventions that lead to longer, healthier lives. Natera's tests are validated by more than 80 peer-reviewed studies that demonstrate high accuracy, improving patient care outcomes in oncology, women's health and organ health. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. For more information, visitwww.natera.com.
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: Kate Stabrawa, Communications, 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.