Joint Guideline from ACOG and SMFM Supports use of Non-Invasive Prenatal Testing (NIPT) for all Pregnant Women
SAN CARLOS, Calif., Aug. 18, 2020 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a leader in non-invasive prenatal testing, announced a joint guideline released yesterday by the American College of Obstetrics and Gynecology (ACOG) and Society of Maternal Fetal Medicine (SMFM), regarding the use of cell-free DNA (cfDNA). The new guideline supports aneuploidy screening in all patients, regardless of maternal age or baseline risk, and highlights, for the first time, that cfDNA-based testing can be performed in twin pregnancies.
"The updated ACOG/SMFM guideline recommends offering screening options to all patients regardless of maternal age or prior risk. It also concludes that, based on Level A evidence, NIPT is the most sensitive and specific screening test available for common fetal aneuploidies. We believe that this change is an important precursor to broader coverage and utilization of NIPT," said Dr. Russ Jelsema, Maternal Fetal Medicine Specialist and Sr. Medical Director of Women’s Health at Natera. "The guideline also highlights unique aspects of SNP-based NIPT technology, including detection of triploidy, use as early as 9 weeks, and the ability to assess zygosity and individual fetal fraction when testing twins."
"Natera’s market leadership is driven by its strength of evidence and clinical differentiation documented in 22 peer-reviewed publications including over 1.3 million patients," said Sheetal Parmar, Genetic Counselor and VP of Medical Affairs at Natera. Natera has also sponsored the SMART (SNP-based Microdeletion and Aneuploidy Registry Trial) study, the largest prospective NIPT study to date. This real-world study across 21 global sites, with confirmatory diagnostic microarray on each sample, including both high and average risk patients, is expected to further support the statements in the guideline. In addition, the study, with publications planned in 2021, will report on screening for common microdeletions which represents additional opportunity for Natera.
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. Panorama results have been published in over 25 peer reviewed papers covering roughly 1 million patients.
Panorama has been developed and its performance characteristics determined by the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). Although FDA is exercising enforcement discretion of premarket review and other regulations for laboratory-developed tests in the US, certification of the laboratory is required under CLIA to ensure the quality and validity of the tests. CAP accredited, ISO 13485 certified, and CLIA certified. © 2020 Natera, Inc. All Rights Reserved.
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.
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.
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