Natera Announces Innovation Roadmap, with Advancements in MRD and Early Cancer Detection

Company to provide comprehensive update in a presentation delivered today at the 43rd Annual J.P. Morgan Healthcare Conference

Presentation outlines strength of existing oncology portfolio, along with pipeline of new products and data readouts

AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, will provide an update to the investment community, today, at the 43rd annual J.P. Morgan Healthcare Conference. In addition to its previously announced preliminary financial results for the fourth quarter and year ended Dec. 31, 2024, the Company will also present details on its innovation roadmap for oncology.

“Building on our strong preliminary financial results in 2024, we are poised for an exciting year with multiple potential catalysts,” said Steve Chapman, CEO. “Since launching the oncology business, we have focused on innovating the field of molecular residual disease testing to improve outcomes for patients. Today's announcement extends that commitment with promising new products and technologies in cancer testing.”

Launch of Signatera^TM, Designed on Genome

Building on the success of Natera’s exome-based Signatera assay, which has been extensively validated and widely adopted, Natera is pleased to introduce a new version of Signatera leveraging the genome. The test, which is now available for research and clinical use, enables bespoke assay design from a whole genome sequence (WGS) of a patient’s tumor.

The Signatera genome assay benefits from Natera’s patented multiplex polymerase chain reaction (PCR) next generation sequencing (NGS) methodology. The test detects down to low single-digit parts per million (PPM) and leverages Natera’s clinical data leadership from over 100 published studies on circulating tumor DNA (ctDNA) monitoring.

Tissue-free MRD

Natera is pleased to unveil a new tissue-free molecular residual disease (MRD) capability, which is the result of growing expertise in methylation-based technologies and dovetails with its research in early cancer detection. The first launch is expected in mid-2025 in colorectal cancer (CRC), with additional tumor indications to follow. The preliminary data for the CRC assay will be presented at the American Society of Clinical Oncology (ASCO) GI symposium, which takes place Jan. 23-25, 2025.

The Signatera genome assay and the tissue-free MRD assay will be offered alongside the Signatera exome assay, as part of Natera’s portfolio of MRD assays.

Early Cancer Detection (ECD)

The company will also provide the first performance data for its ECD assay, based on the detection of cancer-specific DNA methylation signatures. Natera brings a unique competitive advantage to its ECD program, with access to an extensive amount of early-stage and presurgical tumor samples for use in development, combined with intended use samples from its PROCEED-CRC study. Prospective case-control data to be presented at ASCO GI demonstrated 92% detection of stage 1 CRC and 95% detection overall, at a specificity level of 91%. Advanced adenoma (AA) data and additional CRC data from the PROCEED-CRC cohort are expected to be shared later this year. Pending a positive signal from those readouts, Natera will pursue an FDA-grade validation study.

Presentation and Webcast Details

A presentation outlining the details of this business update will be posted to the Investor Relations (IR) section of Natera’s website at www.investor.natera.com. A webcast will also be broadcast and available on the IR site, beginning at 12:00 pm ET | 9:00 am PT, with a replay available shortly thereafter.

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 that could affect our financial results are discussed in greater detail in the sections titled "Risk Factors" and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our most recent filings on Forms 10-K and 10-Q and in other filings that we make with the SEC from time to time. These documents are available at www.investor.natera.com and on the SEC’s website at www.sec.gov.