Presentations include largest analysis from the
GALAXY study in colorectal cancer with updated 24-month
disease-free survival data, and expanded Signatera readout in
rectal cancer
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
testing, today announced it will present new data on its
personalized and tumor-informed molecular residual disease (MRD)
test, Signatera, at the 2023 European Society for Medical Oncology
(ESMO) Congress, taking place Oct. 20-24 in Madrid, Spain.
Natera and its collaborators will present MRD data in a total of
seven abstracts, including a mini-oral and several poster
presentations. The mini-oral presentation will feature an updated
analysis of more than 2,000 patients from the GALAXY observational
arm of the CIRCULATE-Japan trial, one of the largest and most
comprehensive prospective studies of MRD testing in resectable
colorectal cancer (CRC). Other presentations will highlight new
Signatera data in rectal cancer, appendiceal adenocarcinoma,
hepatocellular carcinoma, renal cell carcinoma, and other solid
tumors.
“We look forward to the presentation of updated data from the
landmark CIRCULATE-Japan study. With twice the number of patients
and significantly longer follow-up, this report reinforces earlier
findings published in Nature Medicine that Signatera can help to
identify those patients with resectable colorectal cancer who will
benefit most from adjuvant chemotherapy,” said Minetta Liu, MD,
chief medical officer of oncology at Natera. “Other collaborative
presentations at ESMO underscore the utility of MRD testing across
multiple indications, including the prediction of clinical outcomes
and improved risk stratification for rectal cancer patients treated
with neoadjuvant therapy.”
Below is the full list of Natera presentations at ESMO:
Mini Oral Presentation:
Presentation #558MO | CRC | Presenter: Yoshiaki Nakamura, MD,
PhD | Oct 22, 14:45 - 16:20 – Lecture: 15:50-15:55
Circulating tumor (ct)DNA as a prognostic biomarker in patients
(pts) with resected CRC: an updated 24 months (mos) disease free
survival (DFS) analysis from GALAXY study (CIRCULATE-Japan)
An updated analysis from the CIRCULATE-Japan study builds on the
existing evidence from the recently published, prospective,
observational GALAXY study, demonstrating the prognostic value of
ctDNA in >2,000 CRC patients at 24 months.
Poster Presentations:
Presentation #590P | Rectal Cancer | Oct. 22 | Presenter:
Chiara Molinari, PhD Assessment of ctDNA in pts with locally
advanced rectal cancer (LARC) treated with neoadjuvant therapy
(NAT)
These new data show that ctDNA monitoring may predict
neoadjuvant treatment response and long-term survival outcomes in
patients with LARC.
Presentation #649P | Appendiceal Cancer | Oct. 22 |
Presenter: Michael G. White, MD, MSc The genomic landscape of
appendiceal adenocarcinoma (AA) revealed by 855 Whole Exome
Sequences (WES)
The first large-scale genomic profiling study of AA demonstrates
its mutational profile is distinct from rectal and colon cancer,
suggesting a different oncologic pathway for this cancer type.
Presentation #1224P | Pan-Cancer | Oct. 22 | Presenter:
Yoshiaki Nakamura, MD, PhD Detection of ctDNA in untreated pts
with cancer: implications for early cancer detection (ECD)
This study of treatment-naive cancer patients reveals that
tumor-informed ctDNA detection varies by cancer type, stage, and
driver mutations. These findings have implications for development
of assays for ECD.
Presentation #960P | Hepatocellular Carcinoma | Oct. 23 |
Presenter: Maen Abdelrahim, MD, PhD Personalized ctDNA
monitoring for recurrence detection and treatment response
assessment in hepatocellular carcinoma (HCC)
These findings support a role for longitudinal ctDNA assessment
in identifying early recurrence post-surgical resection in patients
with HCC.
Presentation #114P | Biliary Tract Cancer | Oct. 23 |
Presenter: Gentry King, MD Prospective Longitudinal
Tumor-Informed ctDNA in Resectable Biliary Tract Cancers (BTC)
In patients with BTC, ctDNA detection may help in evaluating
clinical outcomes prior to radiographically evident disease.
Presentation #1908P | Renal Cancer | Oct. 23 | Presenter:
Michael Smigelski, MD Utility of ctDNA testing for MRD
detection and treatment response monitoring in pts with renal cell
carcinoma (RCC)
This study demonstrates that longitudinal ctDNA monitoring may
be predictive of recurrence-free survival post-surgery in patients
with RCC.
About Signatera
Signatera is a custom-built circulating tumor DNA (ctDNA) test
for treatment monitoring and molecular residual disease (MRD)
assessment in patients previously diagnosed with cancer. The test
is available for both clinical and research use, and has been
granted four Breakthrough Device Designations by the FDA for
multiple cancer types and indications. The Signatera test is
personalized and tumor-informed, providing each individual with a
customized blood test tailored to fit the unique signature of
clonal mutations found in that individual’s tumor. Signatera is
intended to detect and quantify cancer left in the body, at levels
down to a single tumor molecule in a tube of blood, to identify
recurrence earlier and to help optimize treatment decisions. The
test has not been cleared or approved by the US Food and Drug
Administration (FDA).
About Natera
Natera™ is a global leader in cell-free DNA 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 150 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20231016308600/en/
Investor Relations: Mike Brophy, CFO, Natera, Inc.,
510-826-2350, investor@natera.com Media: Lesley Bogdanow, VP of
Corporate Communications, Natera, Inc., pr@natera.com
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