Natera, 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. 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, chief executive officer 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."

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. 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.