A NIPT to screen for single gene disorders using cfDNA
SAN CARLOS, Calif., May 8, 2017 /PRNewswire/ — Natera (NASDAQ: NTRA), a leader in genetic testing, announced the launch of Vistara, a non-invasive prenatal test (NIPT) to screen single-gene disorders. Vistara is a complement to Natera’s market-leading Panorama® non-invasive prenatal test (NIPT) and screens for new mutations in 30 genes that have a combined incidence rate of nearly 1 in 600, which is higher than that of Down syndrome.1, 2 These mutations can cause severe conditions that affect skeletal, cardiac, and neurological systems, and often go undetected with routine prenatal screening. Natera will offer Vistara through its leading direct sales channel in the United States.
Natera has partnered with Baylor Genetics to commercialize Vistara and is initially launching the test to Maternal Fetal Medicine specialists (MFMs) at leading clinics throughout the U.S., and broadly to Obstetrician-Gynecologists (OBGYNs) at a later date, after market education and support. Vistara expands Natera’s existing portfolio of women’s reproductive health products and will also be well positioned to immediately take advantage of Natera’s well-established commercial capabilities, including patient and healthcare provider digital services through Natera’s Patient Portal and Natera Connect, and a specialized salesforce that already calls on the nation’s busiest MFMs and OBGYNs.
"Screening for single-gene disorders early in pregnancy can be extremely helpful and is an important next step in the ability to screen for fetuses with major anatomic abnormalities and chromosome imbalances," said Dr. Brian Krishon, a Maternal Fetal Medicine specialist at Houston Perinatal Associates. "As just one example, prenatal screening with confirmatory diagnostic testing for osteogenesis imperfecta (OI) can result in reduced bone fractures through adjusted delivery and post-natal management."
"This is a paradigm shift in prenatal screening. This technology screens for new mutations that are common and cannot be detected by standard carrier screening, as these mutations are not present on the parents," said Matt Rabinowitz, CEO and founder of Natera. "Our expansion into screening for single-gene mutations builds on the success of Panorama, the market-leading NIPT for common trisomies and microdeletions, and furthers Natera’s mission to transform the diagnosis and management of genetic diseases."
Addressing an Unmet Clinical Need
Vistara screens for common single-gene disorders such as Noonan syndrome, osteogenesis imperfecta, craniosynostosis syndromes, achondroplasia, and Rett syndrome. Noonan syndrome, for example, has non-specific ultrasound findings and may not be detected prenatally without single-gene testing. Noonan syndrome is characterized by short stature, cardiac defects, bleeding problems and mild intellectual disabilities in some cases. It affects 1 in 1,000 to 1 in 2,500 births.
The incidence of the diseases screened by Vistara is higher than that of cystic fibrosis, which is commonly screened by OBGYNs and is well reimbursed. In addition, these conditions are not screened with existing NIPTs. Ultrasound exams may either completely miss these disorders or identify non-specific findings late (2nd or 3rd trimester) in the pregnancy. Further, family history is not a good indicator of risk for these conditions, which are commonly caused by de novo (not inherited) mutations. Vistara has a combined analytical sensitivity of >99% and a combined analytical specificity of >99% in validation studies.3 Given the combined high incidence of these disorders, Vistara may be used to screen all singleton pregnancies after nine weeks gestation.4 A positive screen result from Vistara will direct the clinician to order the appropriate diagnostic tests, and upon confirmation, guide labor and delivery management, and channel patients to necessary specialists.
Natera is a genetic testing company that develops and commercializes non-invasive methods for analyzing DNA. The mission of the company is to transform the diagnosis and management of genetic disease. In pursuit of that mission, Natera operates a CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, CA, and it currently offers a host of proprietary genetic testing services primarily to OB/GYN physicians and fertility centers, as well as to genetic laboratories through its cloud-based Constellation™ software system.
Product offerings include the Spectrum® pre-implantation genetic test for embryo selection during IVF; the Anora® miscarriage test to understand the genetic causes of a pregnancy loss; the Horizon™ carrier screen to detect inherited mutations; the Panorama® non-invasive prenatal test (NIPT) to screen for common chromosomal anomalies in a fetus as early as nine weeks of gestation; the Vistara NIPT to screen for single-gene disorders and Evercord™, a cord blood and tissue banking service offered at birth to expectant parents.
Each test described has been developed and its performance characteristics determined by the CLIA-certified laboratory performing the test.
These tests have 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 also applying its unique technologies to develop non-invasive screening and diagnostic tools for earlier detection and improved treatment of cancer. These tests have not been cleared or approved by the U.S. Food and Drug Administration.
This release contains forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. Any forward-looking statements contained in this press release are based upon Natera’s historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release.
Subsequent events may cause these expectations to change, and Natera disclaims any obligation to update the forward-looking statements for any reason after the date of this press release. These forward-looking statements are subject to a number of 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 the sections entitled "Risk Factors" and "Management’s Discussion and Analysis of Financial Condition and Results of Operations" in Natera’s Form 10-K for the year ended December 31, 2016. Further information on potential risks that could affect actual results will be included in other filings Natera makes with the SEC from time to time. These documents are available for free on the company’s website at www.natera.com under the Investor Relations section, and on the SEC’s website at www.sec.gov.
Mike Brophy, Chief Financial Officer, 650-249-9091 x1471
Laura Zobkiw, Corporate and Media Relations, 650-249-9091 x1649
1 GeneReviews. https://www.ncbi.nlm.nih.gov/books/NBK1116/
2 Genetics Home Reference. https://ghr.nlm.nih.gov/
3 Validation data, Baylor. 2016
4 Vistara is not available for mothers who are known to be affected with a disorder involving one of the genes on the panel.