Natera: Latest Landmark SMART Study Publication Confirms High Accuracy of Natera Panorama® NIPT for Screening Common Aneuploidies
AUSTIN, Texas, February 17, 2022 –Natera, Inc.(NASDAQ: NTRA), a world leader in cell-free DNA (cfDNA) testing,announced that another manuscript of the landmark SMART study has been published in the American Journal of Obstetrics and Gynecology(AJOG), one of the world’s leading medical journals of obstetrics and gynecology. This publicationdescribes the performance of the SNP-based noninvasive prenatal test (NIPT) Panorama to screen for common aneuploidies.1Earlier this month, results from the SMART study for screening for 22q11.2 deletion syndrome were also publishedin AJOG.2
SMART is the largest prospective NIPT study ever, with more than 20,000 patients enrolled at 21 US and international sites. All results included in the analysis have been validated by genetic confirmation. The study rigorously tested Panorama, confirming its market-leading performance in a real environment. 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 main results of this publication include:
- Panorama demonstrated 99% sensitivity and >99.95% specificity for trisomy 21 in a real-world setting, consistent with previously published studies.3
- Panorama’s positive predictive value (PPV) for trisomy 21 was 95%. This PPV means that for every 100 positive results, 95 were confirmed to have trisomy 21. trisomy 21. .4
- Panorama AI maintained high sensitivity, detected additional cases of common aneuploidies, and significantly lowered the no-call rate to 1.5% and 0.6% after re-draw.
“Panorama’s unique performance and capabilities have now been documented in 25 peer-reviewed publications, including more than 1.3 million patients – more patients than all other NIPTs combined. With SMART, we have demonstrated excellent performance, in a large prospective study,” said Ramesh Hariharan. , Managing Director of Women’s Health at Natera. “We are proud of our commitment to innovation and the ability to positively impact millions of pregnancies, dramatically reducing Panorama’s prior false positive rate for prenatal screening.
“Natera thanks the SMART researchers for their work on this landmark study,” said Dr. Russ Jelsema, Senior Medical Director of Women’s Health at Natera. “By giving families critical and highly accurate information about their baby early in pregnancy, we can both improve outcomes for babies with common chromosomal aneuploidies and provide better support for their unique health needs in later life. birth.”
Panoramareveals 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 sampling 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 it 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 25 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.
Natera™ is a global leader in cell-free DNA testing, dedicated to oncology, women’s health and organ health. Our goal is to integrate personalized genetic testing and diagnostics into the standard of care to protect health and enable earlier, more targeted interventions that help lead longer, healthier lives. Natera’s tests are validated by over 100 peer-reviewed publications that demonstrate high accuracy. Natera operates laboratories that are ISO 13485 certified and CAP accredited under 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 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 ability to successfully increase demand and grow revenue for our product offerings, whether whether the results of clinical studies or other studies will support the use of our product offerings, our expectations regarding the reliability, accuracy, and performance of our tests, or the benefits of our tests and product offerings. products for patients, 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/investorsand www.sec.gov.
Investor Relations: Mike Brophy, Chief Financial Officer, Natera, Inc., 510-826-2350
Media: Kate Stabrawa, Communications, Natera, Inc., [email protected]
- Dar P, Jacobson B, MacPherson C, et al. Cell-free DNA screening for trisomies 21, 18 and 13 in pregnancies at low and high risk of aneuploidy with genetic confirmation. AJOG2022 in press
- Dar P, Jacobsson B, Clifton R, et al. Cell-free DNA screening for prenatal detection of 22q11.2 deletion syndrome. AJOG2022 in press.
- Ryan A, Hunkapiller N, Banjevic M, et al. Validation of an improved version of a non-invasive prenatal test based on single nucleotide polymorphism for the detection of fetal aneuploidies.Fetal diagnosis. 2016;40(3):219-223.
- Norton ME, Jacobsson B, Swamy GK, et al. Cell-free DNA analysis for the non-invasive examination of trisomy. N Engl J Med. 2015;372(17):1589-1597.