Natera Announces New Clinical Utility Data and Issuance of CPT Code for NIPT in Twin Pregnancies
Unique Twin Zygosity Test Adds Clinical Value in Over 1 in 4 Cases
SAN CARLOS, Calif., June 13, 2018 /PRNewswire/ -- Natera (NASDAQ: NTRA), a leader in genetic testing and cell-free DNA analysis, announces that the American Medical Association has issued a new CPT code for zygosity testing in twin pregnancies. Zygosity refers to whether twins are identical (mono-zygotic) or non-identical (di-zygotic) and is closely linked with risks for placental disorders that can occur in identical twin pregnancies.
Panorama® is the only NIPT that is able to evaluate zygosity, and it is clinically validated with > 99% accuracy as early as nine weeks' gestation.1
Natera has generated new utility data2 from an analysis of the first 5,000 commercial zygosity cases processed by Natera since its launch of the Panorama zygosity test in 2017: more than 1 in 4 clinicians marked that they were "unsure" – based on ultrasound alone – whether the babies shared a single placenta. When twins share a single placenta, which generally only happens in the case of identical twins, it increases the risk for potentially lethal disorders like twin-twin transfusion syndrome (TTTS), so specialty care and extra surveillance are required. Natera's analysis showed that 70% of the "unsure" cases were non-identical, therefore with separate placentas, so those parents could avoid the specialty care and feel reassured. The Panorama zygosity test also helped reclassify up to 3.4% of cases from high-risk to low-risk, because the ordering physicians saw a single placenta on ultrasound, but Panorama reported non-identical twins.
"The ability to determine zygosity in twin pregnancies is clinically very valuable," said Errol Norwitz, M.D., Ph.D., CSO, Professor and Chair of Obstetrics & Gynecology, Tufts Medical Center. "This test can help doctors triage patients appropriately to heightened surveillance versus routine care, and it can help avoid under- and over-treatment."
Panorama is the only non-invasive prenatal test (NIPT) that can tell the difference between the mother's and the baby's DNA. This unique technology enables Panorama to offer a zygosity report and the fetal sex of each twin as early as nine weeks' gestation.1 Panorama identified mono-zygotic twins with greater than 99% sensitivity and specificity in validation studies.1 The test also helps identify risk for more genetic conditions in twin pregnancies than other NIPTs, including trisomies 21, 18, and 13; monosomy X; sex chromosome trisomies; and 22q11.2 deletion syndrome.* Panorama is one of several products from Natera that help women on the path to parenthood.
Natera is a global leader in cell-free DNA testing. The mission of the company is to transform the diagnosis and management of genetic diseases. 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.
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 Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090 Media: Barbara Sullivan, Sullivan & Associates, 714-374-6174, firstname.lastname@example.org
Natera validation data. Manuscript in preparation.
Natera commercial data, Oct. 2017-May 2018.
*Sex chromosome trisomies and 22q11.2 deletion syndrome available for monozygotic twins only.