SMART Study Data for Aneuploidy and 22q Unblinded
Natera, Inc. (NASDAQ: NTRA) announced the unblinding of its SMART clinical trial data, validating its AI-enhanced Panorama non-invasive prenatal test (NIPT). The study, involving over 18,000 patients, demonstrated improved accuracy for detecting aneuploidies and microdeletions, particularly the 22q deletion syndrome. Natera performed over 105,000 22q tests in Q2 2020, suggesting strong market demand. Positive payer coverage is anticipated due to favorable pricing from CMS. The company aims to influence guidelines to support universal screening for 22q deletion syndrome.
- Validation of AI in Panorama NIPT improves accuracy for aneuploidies and microdeletions.
- Performance tested on over 18,000 patients in the SMART study.
- Over 105,000 22q deletion syndrome tests performed in Q2 2020.
- Favorable pricing from CMS may result in positive payer coverage.
- None.
SAN CARLOS, Calif., Sept. 2, 2020 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a pioneer and leader in cell-free DNA testing, today announced the unblinding of the SMART clinical trial data, and the validation of an artificial intelligence-based (AI) platform as part of its Panorama non-invasive prenatal test (NIPT).
Panorama with AI uses deep neural networks and learns from over 2 million cell-free DNA tests that Natera has processed in order to further improve on its market-leading accuracy for common aneuploidies and microdeletions. The historical performance of Panorama and its performance using the new algorithm were tested prospectively in the multi-site SMART (SNP-based Microdeletion and Aneuploidy Registry Trial) study.
Both aneuploidy and microdeletion calls were compared to fetal or infant genetic outcomes evaluated with karyotype or chromosomal microarray on all of the more than 18,000 patients included. Unlike aneuploidies, the prevalence of microdeletions, including the most common 22q.11.2 deletion, and their detection by NIPTs have not been studied extensively. Further, published evidence shows important differences in performance for aneuploidies and microdeletions, between SNP and counting-based NIPTs. Panorama with AI improves on Natera's market-leading performance and is designed to detect even smaller sizes of microdeletions than previously possible.
"22q deletion syndrome is the most common microdeletion syndrome with an incidence comparable to cystic fibrosis and spinal muscular atrophy, which are commonly screened," said Paul Billings M.D., Ph.D., Natera's Chief Medical Officer. "Current tools to diagnose the condition are insufficient, especially in non-cardiac cases. Children diagnosed with 22q deletion syndrome need to be delivered in a tertiary care facility, where early intervention can profoundly impact outcomes."
"We very much look forward to sharing the results from SMART related to the prevalence of 22q deletion syndrome in the general population, the performance of the SNP-based NIPT in the historical registry study, and the performance of Panorama with AI," said Steve Chapman, Natera's CEO. "We believe the collective evidence generated from this study will inform professional societies and commercial payers to support screening for 22q deletion syndrome for all pregnancies, regardless of maternal age, and support the recent ACOG guidelines for chromosomal aneuploidies."
In the second quarter of this year alone, Natera performed over 105,000 22q deletion syndrome tests. Given the previously announced favorable pricing from CMS and the large volume of testing already performed, positive payer coverage could result in significant upside for Natera.
About the SMART study
Natera has sponsored the SMART (SNP-based Microdeletion and Aneuploidy Registry Trial) study, the largest prospective NIPT study to date. This real-world study compared aneuploidy and microdeletion calls to fetal or infant genetic outcomes evaluated with karyotype or chromosomal microarray on all of the more than 18,000 patients. The study enrolled both high and average risk patients, and is expected to further support the statements in the 2020 ACOG/SMFM guideline. In addition, the study, with publications planned in 2021, will provide important new evidence on screening for common microdeletions.
About Panorama®
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, 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.
About Natera
Natera is a pioneer and global leader in cell-free DNA testing. 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 an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, California. 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.
Forward-Looking Statements
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 coverage and reimbursement determinations from third-party payers and any resulting effects on our results of operations, whether the results of clinical or other studies will support the use of our product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening 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.
Contacts
Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090
Media: Paul Greenland, VP of Corporate Marketing, Natera, Inc., pr@natera.com
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SOURCE Natera, Inc.
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