Natera Announces Innovation Roadmap, with Advancements in MRD and Early Cancer Detection
15 January 2025 - 11:00PM
Business Wire
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
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 SignateraTM, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20250115920690/en/
Investor Relations: Mike Brophy, CFO, Natera, Inc.,
650-249-9090, investor@natera.com Media: Lesley Bogdanow, VP of
Corporate Communications, Natera, Inc., pr@natera.com
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