Natera Panorama SMART study results accepted for publication by the American Journal of Obstetrics and Gynecology (AJOG)
AUSTIN, Texas, November 19, 2021 / PRNewswire / – Natera, Inc. (NASDAQ: NTRA), a leader in personalized genetic testing and diagnostics, announced that the first SMART study manuscript 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 and the only one to obtain genetic confirmation of results from all patients in the analysis. The study rigorously tested Panorama’s performance, confirming its performance as a market leader in a real-world environment and extending Panorama’s position as the most studied NIPT in the market. The study also included the validation of a new artificial intelligence-based deep learning algorithm for Panorama called Panorama AI, which uses information from more than 2 million cfDNA tests performed by Natera.
The SMART study enrolled more than 20,000 patients over five years at 21 US and international sites. All patients received Panorama as part of routine clinical care. The main results of this initial publication include:
Panorama has demonstrated a sensitivity of 99% and a specificity of more than 99.5% for Down’s syndrome in a real setting, in accordance with previously published studies.1-2
Panorama AI maintained high sensitivity, detected additional cases of common aneuploidy, and drastically reduced the no-call rate to 1.5% and 0.6% after re-draw.1
“We are proud to have sponsored the SMART study, the largest prospective NIPT validation study ever, which focused on a general population cohort and used the gold standard of diagnostic tests for the genetic truth, ”said Ramesh Hariharan, Managing Director of Natera’s Women’s Health business. “This study demonstrates the excellent performance of SNP-based NIPT in a real-world environment, giving medical practitioners around the world greater confidence in screening for common trisomies in their pregnant patients.”
The SMART data described here has been previously presented at SMFM 2021.
Panorama reveals the risk for a baby of developing serious genetic disorders as early as nine weeks of pregnancy. The test uses unique nucleotide polymorphism (SNP) technology to analyze fetal / placental DNA obtained from a blood sample from the mother. It is the only commercially available test that differentiates maternal DNA from fetal DNA to assess the risk of aneuploidies. The test also examines twin pregnancies for each baby’s zygosity and fetal sex, and identifies the risk of more genetic diseases in twin pregnancies than any other PND. Panorama is one of Natera’s many genetic screening tests 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 space today. Panorama was developed and its performance characteristics determined by Natera, the CLIA certified laboratory performing the test. The test has not been authorized or approved by the United States Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified and CLIA certified.
Natera ™ is a leader in personalized genetic testing and diagnostics, transforming the way we make critical healthcare decisions. Our genetic and diagnostic tests help clinicians and their patients protect their health and enable earlier, more targeted interventions that lead to longer, healthier lives. Natera’s tests are validated by over 80 peer-reviewed studies that demonstrate high accuracy, improving oncology patient care outcomes, women’s health and organ health. Natera operates ISO 13485 certified and CAP accredited laboratories certified according to the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. For more information visit www.natera.com.
All statements other than statements of historical fact contained in this press release are forward-looking statements and do not constitute a representation that Natera’s plans, estimates or expectations will be realized. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update any 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 market new product offerings, our ability to successfully increase demand and income from our product. offers, that the results of clinical or other studies will support the use of our product offerings, our expectations for the reliability, accuracy and performance of our tests, or the benefits of our tests and product offerings for them. patients, providers and payers. Additional risks and uncertainties are discussed in more detail in the “Risk Factors” section in recent documents filed by Natera on Forms 10-K and 10-Q and in other documents that Natera submits from time to time to the DRY. These documents are available on www.natera.com/investisseurs 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 PNS-based cfDNA screening for aneuploidy with genetic confirmation in 18,496 pregnancies [abstract]. Maternal-Fetal Society Medication. Virtual meeting. Oral presentation 62. January 25-30, 2021.
Ryan et al. Fetal diagnosis. 2016; 40 (3): 219-223.
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