Natera Announces Commercial Launch of Zenith™ Genomics for Rare Disease Diagnosis

New genomic testing solution designed to shorten diagnostic journeys for patients and families;

supports efforts to reduce the economic and societal burden of rare diseases in the U.S.A.

AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the commercial launch of Zenith genomics, its next-generation whole genome sequencing assay designed to significantly improve the detection of rare diseases. Natera is presenting on Zenith’s unique platform and performance at the 2026 American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting, taking place this week in Baltimore, Maryland.

Zenith genomics was built to address one of the most critical challenges in medicine: timely and accurate diagnosis of rare genetic conditions. Rare diseases affect an estimated 30 million Americans annually¹, many of whom experience prolonged diagnostic odysseys (4-7 years on average). The cumulative economic burden of rare diseases in the United States was nearly $997 billion in 2019, including $449 billion in direct medical costs and $548 billion in indirect and non-medical costs, underscoring the scale of unmet need and societal impact.¹

Powered by advanced sequencing and interpretation technology, Zenith genomics provides enhanced resolution of typically hard to detect features such as tandem repeat expansions by using long-read sequencing confirmation to provide comprehensive diagnostic clarity. It utilizes a whole genome sequencing backbone, allowing the most comprehensive analysis, and can support diagnosis of many rare and ultra-rare diseases, guidance for targeted therapies and improved long-term clinical management.

The underlying technology supporting Zenith genomics was developed by MyOme, a leading clinical whole genome analysis company helping families understand disease risk. Through this exclusive partnership, Natera will bring Zenith genomics to healthcare providers across the United States, leveraging its extensive electronic medical records (EMR) integration footprint, robust clinical support system and unparalleled experience in high-complexity genomics. This unified infrastructure supports efficient ordering to complement Natera’s other genomic offerings, enhancing value for clinicians, patients and health systems alike.

“Rare disease patients and their families endure lengthy and costly diagnostic journeys that often delay care and escalate emotional and financial strain,” said Meredith Reichert, Ph.D., senior vice president of commercial and general manager of rare disease at Natera. “By combining MyOme’s innovation with Natera’s nationwide presence and clinical expertise, Zenith has the potential to transform rare disease diagnostics and provide definitive answers to more families.”

“Our mission at MyOme has always been to unlock the full potential of the genome to improve health outcomes,” said Akash Kumar, M.D., Ph.D., chief medical officer at MyOme. “Partnering with Natera allows us to scale Zenith rapidly and responsibly, ensuring that advanced sequencing tools reach the patients who need them most.”

With increasing recognition of genomic sequencing as a standard of care in rare disease evaluation and broad coverage from state and commercial payers, Zenith genomics is well positioned to capture meaningful market adoption. Strong reimbursement rates for comprehensive genomic testing reflect both clinical utility and payer alignment with evidence-based precision diagnostics.

Natera’s presentations at ACMG showcase the Zenith genomics platform across diverse rare disease patients, highlighting real-world utilization insights. Additional information on Natera’s ACMG presentations can be found here.

References

1. Yang, G., Cintina, I., Pariser, A. et al. The national economic burden of rare disease in the United States in 2019. Orphanet J Rare Dis 17, 163 (2022). https://doi.org/10.1186/s13023-022-02299-5

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 or our partners’ 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.