Natera to Launch Enhanced Panorama™ NIPT, Powered by Novel SNP-Informed Deep Sequencing Technology

Study provides prospective, clinically-validated performance data at challenging low fetal fraction levels, raising industry standard

Reduces no-call rate to 0.5%, enabling results for more patients and closing a key competitive gap

AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) testing and precision medicine, today announced a major enhancement to its Panorama non-invasive prenatal test (NIPT). Powered by the company’s novel SNP-informed deep sequencing technology, Panorama NIPT is now backed by clinically-validated performance data in samples with low fetal fraction, enabling a no-call rate of 0.5%.

Fetal fraction refers to the proportion of placental DNA circulating in a pregnant patient’s blood sample. Low fetal fraction can make it more difficult to accurately detect chromosomal abnormalities in prenatal screening. Patients with low fetal fraction are associated with a significantly increased risk of aneuploidy.

Prior literature highlights challenges with sensitivity at low fetal fractions with some counting-based NIPT methods, with one study indicating 62% sensitivity for trisomy 21 at low fetal fraction.^1,2 Despite this limitation, most counting-based NIPTs routinely provide results at low fetal fraction without providing clinical performance data specifically for these populations.

To address this unmet need, Natera developed and validated SNP-informed deep sequencing technology to improve NIPT performance at low fetal fractions while preserving the unique advantages of Panorama’s SNP-based methodology.

Panorama with SNP-informed deep sequencing technology is supported by a prospective, blinded clinical validation study of 3,323 high- and low-risk pregnant patients, including 242 samples with low fetal fraction or that would not have received a result otherwise. All samples had outcomes confirmed by diagnostic genetic testing. While most counting-based NIPT studies report blended performance across fetal fractions, thereby obscuring performance at low fetal fractions, results from this study demonstrated strong clinical performance explicitly in patients at low levels of fetal fraction, including 100% sensitivity for trisomy 21, 93.3% sensitivity for trisomy 18, and 100% sensitivity for trisomy 13. In addition, the no-call rate was reduced to just 0.5%, enabling more patients to receive actionable results on the first draw and removing a historical competitive gap for Panorama.

“Low fetal fraction has remained one of the most important challenges in non-invasive prenatal screening,” said Sheetal Parmar, M.S., CGC, SVP of Medical Affairs, Women’s Health. “Panorama now combines the power of our proprietary SNP-based approach with a novel deep sequencing technology that maintains strong clinical performance even in low fetal fraction samples. Importantly, we can help more patients receive reliable results without added complexity for providers.”

References

1. Wright et al. Ultrasound Obstet Gynecol. 2015;45(1):48-54.
2. Canick et al. Prenat Diagn. 2013; 33: 667-674.

About Natera

Natera™ is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 400 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit www.natera.com.

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, whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our 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.