Genomics

Natera Commercially Launches Zenith™ Genomics for Rare Disease Diagnosis

Natera Rare Disease Diagnosis Zenith Genomics whole genome sequencing

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.

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.

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

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