Natera’s Panorama SMART Study Results Accepted for Publication by the American Journal of Obstetrics and Gynecology (AJOG)
AUSTIN, TX, November 19, 2021 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a leader in personalized genetic testing and diagnostics, announced that the first manuscript of 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 conducted, and the only one to collect genetic confirmation of results on all patients in the analysis. The study rigorously tested Panorama’s performance, confirming its market-leading performance in a real environment and extending Panorama’s position as the most studied NIPT in the market. The study also included 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 recruited 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 first 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 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 testing for truth. genetics,” 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 setting, giving medical practitioners around the world greater confidence in screening their pregnant patients for common trisomies.”
The SMART data described here has been presented previously at SMFM 2021.
About Panorama®
Panorama reveals a baby’s risk for serious genetic disorders as early as nine weeks of pregnancy. The test uses a unique technology based on single nucleotide polymorphism (SNP) to analyze fetal/placental DNA obtained by blood collection 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 each baby’s zygosity and fetal sex, and identifies the risk of more genetic conditions in twin pregnancies than any other NIPT. 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 more than 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 cleared or approved by the United States Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified and CLIA certified.
About Natera
NateraTM 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 more than 80 peer-reviewed studies that demonstrate high accuracy, improving patient care outcomes in oncology, women’s health, and organ health. Natera operates laboratories that are ISO 13485 certified and CAP accredited under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, TX and San Carlos, California. For more information, visit www.natera.com.
Forward-looking statements
All statements other than statements of historical facts contained in this press release are forward-looking statements and do not constitute 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 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 increase revenue from our product. offerings, whether the results of clinical or other studies will support the use of our product offerings, our expectations regarding the reliability, accuracy, and performance of our tests, or the patient benefits of our tests and product offerings, providers and payers. Additional risks and uncertainties are discussed in more detail in the “Risk Factors” section of Natera’s recent filings on Forms 10-K and 10-Q and in other filings by Natera with the SEC from time to time. other. These documents are available at www.natera.com/investors and www.sec.gov.
contacts
Investor Relations: Mike BrophyChief Financial Officer, Natera, Inc., 510-826-2350
Media: Kate StabrawaCommunications, Natera, Inc., [email protected]
The references
- Dar P, et al. Prospective multicenter study of SNP-based cfDNA screening for aneuploidy with genetic confirmation in 18,496 pregnancies [abstract]. Maternity and Fetal Society Medication. Virtual meeting. Oral presentation 62. January 25-30, 2021.
- Ryan et al. Fetal diagnosis. 2016;40(3):219-223.
SOURCENatera, Inc.
