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
Zenithgenomics 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
Powered by advanced sequencing and interpretation technology, Zenithgenomics 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 Zenithgenomics to healthcare providers across
“Rare disease patients and their families endure lengthy and costly diagnostic journeys that often delay care and escalate emotional and financial strain,” said
“Our mission at MyOme has always been to unlock the full potential of the genome to improve health outcomes,” said
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
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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
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
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