Cross-ancestry polygenic risk score now offered with the Empower™ hereditary cancer test

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, and MyOme, a leading clinical whole genome analysis and polygenic risk modeling company, today announced the launch of an integrated polygenic risk score (iPRS) for personalized breast cancer risk assessment. iPRS, which reports 5-year and lifetime breast cancer risk, offers individuals who receive a negative test result with Natera’s Empower hereditary cancer test the opportunity for further risk assessment using MyOme’s integrated polygenic risk score.

The launch is supported by a validation study published in JCO Precision Oncology¹ of over 130,000 women, which demonstrated that MyOme's cross-ancestry, integrated polygenic risk score significantly improved breast cancer risk prediction over the common clinical measurement, Tyrer-Cuzick (T-C) alone. In the study, up to 8% of women had their T-C lifetime risk of breast cancer reclassified with iPRS, allowing for more informed cancer risk management decisions.

Polygenic risk scores account for the combined impact of different variants in an individual’s genome rather than those in just a single gene. While many polygenic risk scores analyze specific genes or a limited number of variants, iPRS integrates the effect of >1 million single nucleotide polymorphisms (SNPs) from whole genome sequencing with T-C clinical inputs from a patient’s health history to provide a more holistic risk assessment based on genetic ancestry rather than self-reported ancestry alone.

An estimated 1 in 8 women² in the United States will be diagnosed with breast cancer in their lifetime. Early detection and treatment are crucial for improving outcomes. iPRS can provide a more personalized risk assessment for the up to 95% of women who do not have a known pathogenic variant associated with breast cancer.³ By identifying individuals at higher risk, healthcare providers can implement proactive screening, including annual breast MRIs and earlier or more frequent mammograms.

“We are excited to partner with MyOme to further enhance the clinical value of Empower and deliver comprehensive insights about breast cancer risk to women and their healthcare providers,” said Ramesh Hariharan, PhD, MBA, general manager of Women’s Health at Natera. “iPRS addresses a critical need for a cross-ancestry polygenic risk score based on genetic, rather than self-reported, ancestry.”

“We are thrilled to collaborate with Natera to advance MyOme’s vision of predictive healthcare that integrates clinical data with whole genome analysis to develop accurate and personalized risk scores for diseases,” said Akash Kumar, MD, PhD, chief medical and science officer at MyOme. “Our integrated PRS score – the first of many clinically impactful models that will change proactive health – has been thoroughly validated across ancestries and provides a highly accurate risk assessment that enables physicians to construct a personalized screening program to help detect breast cancer in its earliest, most treatable stages. The launch of iPRS marks the beginning of a new age in predictive modeling and proactive health, addressing the vast majority of people who do not have severe genetic mutations and are not currently sick.”

iPRS is available to patients between 18 and 85 years of age who have no personal history of breast cancer and no mutations in a breast cancer-related gene.

References

1. Tshiaba et al., Integration of a Cross-Ancestry Polygenic Model With Clinical Risk Factors Improves Breast Cancer Risk Stratification. JCO Precis Oncol. 2023 Feb;7:e2200447. doi: 10.1200/PO.22.00447
2. American Cancer Society. (2023). Cancer Facts & Figures 2023. Retrieved from https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/2023-cancer-facts-figures.html.
3. National Cancer Institute. (2023). Breast Cancer Statistics. Retrieved from https://seer.cancer.gov/statfacts/html/breast.html.

About Natera

Natera™ is a global leader in cell-free DNA and genetic testing, 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 validated by more than 250 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. For more information, visit www.natera.com.

About MyOme

MyOme^® is a clinical whole genome analysis platform company helping families understand their risk for inherited diseases. As a leader in polygenic modeling, MyOme leverages the power of the whole genome for a lifetime of meaningful and actionable insights. Certified under the Clinical Laboratory Improvement Amendments (CLIA) and certified by the College of American Pathologists (CAP), MyOme is based in Menlo Park, California. For more information, please visit myome.com.

Forward-Looking Statements (Natera)

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 or our partners’ efforts to develop and commercialize 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.

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