Natera Announces Broad Clinical Launch of Ultra-Sensitive Signatera™ Genome MRD Test

Extensive pan-cancer validation data from over 3,000 plasma samples to be presented at ASCO

AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced that its ultra-sensitive Signatera Genome assay is now broadly available to physicians in the United States.

This launch is supported by a large genome-based molecular residual disease (MRD) study, which was accepted and will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. In this clinical validation study of more than 3,000 samples from multiple cancer types – including breast cancer, colorectal cancer, non-small cell lung cancer, melanoma, and renal cell carcinoma – Signatera Genome was able to detect circulating tumor DNA (ctDNA) significantly ahead of clinical recurrence with excellent performance. In addition, postsurgical Signatera-positive patients had inferior recurrence-free survival compared to Signatera-negative patients, consistently across the different cancers that were evaluated. Additional clinical utility data on the Signatera Genome assay, including predictive data, will be presented at the conference.

Signatera Genome is available in CLIA, IUO and RUO and was designed to improve patient management as an ultra-sensitive assay for the detection of ctDNA. The test’s bespoke assay is designed from a whole genome sequence of a patient’s tumor and matched normal DNA. It benefits from Natera’s patented multiplex polymerase chain reaction and next generation sequencing technology (mPCR-NGS), using a targeted and deep sequencing approach to detect tiny traces of tumor DNA at frequencies as low as 1 part per million (PPM). An RUO version of the assay is available that detects below 1 PPM.

“We are extremely pleased with the emerging evidence for our Signatera Genome assay, providing an ultrasensitive MRD detection tool for physicians,” said Alexey Aleshin, M.D., general manager of oncology and corporate chief medical officer. “We look forward to sharing the results of this study, which further demonstrates the clinical utility of Signatera across disease indications.”

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and has coverage from Medicare across a broad range of indications. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 100 peer-reviewed papers.

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.

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 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.