Primary study results on the 20,000 patients anticipated in 2019 to validate the clinical utility of routine screening for microdeletion genetic conditions
SAN CARLOS, Calif., Nov. 29, 2018 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced that it has enrolled 20,000 patients in the SMART (SNP-based Microdeletion and Aneuploidy Registry Trial) study, designed to evaluate the clinical utility of the company’s Panorama® non-invasive prenatal test (NIPT) to screen for aneuploidies and microdeletion genetic conditions, such as 22q11.2 deletion syndrome (DiGeorge syndrome).
The SMART study has enrolled 20,000 women at 21 medical centers around the world. This prospective observational study will review perinatal and birth outcomes of women who chose the Panorama aneuploidy and microdeletion NIPT as part of their prenatal care. Panorama is Natera’s unique SNP-based test, the only NIPT that differentiates between maternal and fetal DNA to determine the risk for chromosome abnormalities.
The primary objective of the SMART study is to prospectively evaluate the performance of Panorama for the most common microdeletion syndrome, 22q11.2 deletion syndrome. Primary study results on the 20,000 patients are anticipated in 2019. Natera expects that the data from this large prospective study will firmly establish the importance of including 22q11.2 deletion syndrome in the list of conditions for which prenatal non-invasive screening is routinely offered to all pregnant women and demonstrate the clinical utility needed to facilitate reimbursement coverage.
"The results of the SMART study will be a critically important addition to the field of cell-free DNA screening," said Pe’er Dar, M.D., Principal Investigator, Director of the Division of Fetal Medicine and Ultrasound, Department of Obstetrics and Gynecology and Women’s Health at Montefiore Medical Center, New York. "While prior studies have reported on the use of cfDNA for the detection of microdeletions, this is the first prospective study using chromosomal microarray analysis on infant’s DNA to accurately assess for presence of microdeletions as well as validate the non-invasive prenatal screen findings."
"Completing the enrollment of 20,000 patients into the SMART study is a major accomplishment for all investigators and centers participating in this multicenter, multinational study," said Mary E. Norton, M.D., Principal Investigator, Professor of Obstetrics, Gynecology and Reproductive Sciences, and Vice Chair of Clinical and Translational Genetics at UCSF Medical Center’s Prenatal Diagnostic Center. "We believe the results of this study and the wealth of data obtained will not only push the field of prenatal genetic testing forward but will also add significantly to our understanding of 22q11.2 deletion syndrome."
22q11.2 deletion syndrome occurs when a small part of DNA is missing from chromosome 22. This results in mild to severe medical conditions, which can include heart defects, poor immune system function, cleft palate, complications related to low levels of calcium in the blood, schizophrenia in adulthood, predisposition to renal and kidney disease, and delayed development with behavioral and emotional differences such as autism and attention-deficit hyperactivity disorder (ADHD). It is usually not inherited and may not be diagnosed until childhood, which may result in families spending years searching for the cause of their child’s medical differences. Unlike Down syndrome, the probability of the disorder is not related to the age of the mother. Because it is independent of maternal age, the probability of 22q11.2 deletion syndrome in children born to women under 28 years old may be higher than that of Down syndrome.1, 2
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 test that differentiates between maternal and fetal DNA in the relevant chromosomes of interest. 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.3 Panorama is one of several genetic screening tests from Natera designed to help families on the path to parenthood.
This test was developed by Natera, Inc., a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). Although FDA does not currently clear or approve laboratory-developed tests in the U.S., certification of the laboratory is required under CLIA to ensure the quality and validity of the tests.
Natera is a global leader in cell-free DNA testing. The mission of the company is to change the management of disease worldwide. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif. It offers a host of proprietary genetic testing services to inform physicians who care for pregnant women, researchers in cancer including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. Follow Natera on LinkedIn and Twitter.
Natera 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 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 studies will support the use of 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 for Natera
Mike Brophy, CFO, Natera, 650-249-9090
Barbara Sullivan, Sullivan & Associates, 714-374–6174, email@example.com
1https://www.cdc.gov/ncbddd/birthdefects/downsyndrome/data.html, accessed November 2018
2https://ghr.nlm.nih.gov/condition/22q112-deletion-syndrome#statistics, accessed November 2018
3Natera validation data. Manuscript in preparation.
SOURCE Natera, Inc.