Natera Announces Expanded I-SPY 2 Collaboration to Evaluate Signatera™ for Breast Cancer Patients in the Neoadjuvant Setting
14 Setembro 2023 - 10:00AM
Business Wire
Prospective study to monitor 600 patients in
real time, across all subtypes of breast cancer
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
testing, today announced a new study as part of the I-SPY 2 trial,
sponsored and operated by Quantum Leap Healthcare Collaborative,
that will use Signatera, Natera’s personalized and tumor-informed
molecular residual disease (MRD) test, to monitor response to
neoadjuvant therapy in breast cancer patients across all
subtypes.
This prospective study, in which 600 patients will be monitored
in real time, will support efforts to establish circulating tumor
DNA (ctDNA) as a composite endpoint and generate additional data on
post-surgical ctDNA status in patients treated with neoadjuvant
therapy. It expands on the existing collaboration with the ISPY-2
consortium that has led to the publication of multiple studies
validating the use of Signatera for neoadjuvant response monitoring
and predicting recurrence risk, including studies published in
Cancer Cell1 and Annals of Oncology.2
“We are excited to expand our collaboration and help generate a
large, prospective dataset to support the incorporation of ctDNA
testing into future interventional trials in neoadjuvant breast
cancer treatment,” said Laura Esserman, MD, MBA, and Laura van ‘t
Veer, PhD, professors at the University of California, San
Francisco, and principal investigators of the I-SPY study. “We
believe this study, in combination with our prior work in I-SPY 2,
will help us understand the role that ctDNA can play in decision
making for predicting response and improving our ability to
determine who needs less therapy and who needs more. This is of
utmost importance to patients.”
“There is a significant unmet need for more accurate tools to
enable precision care for patients diagnosed with breast cancer,”
said Minetta Liu, MD, chief medical officer of oncology at Natera.
“I-SPY 2 serves as an excellent platform to investigate Signatera’s
utility in the neoadjuvant and adjuvant settings. This extended
collaboration will enhance our understanding of Signatera’s ability
to assess therapy response, predict clinical outcomes, and advance
a more personalized treatment strategy for patients with breast
cancer.”
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.
References:
- Magbanua MJM, Swigart LB, Ahmed Z, et al. Clinical significance
and biology of circulating tumor DNA in high-risk early-stage
HER2-negative breast cancer receiving neoadjuvant chemotherapy.
Cancer Cell. 2023;41(6):1091-1102.
- Magbanua MJM, Swigart LB, Wu H-T, et al. Circulating tumor DNA
in neoadjuvant-treated breast cancer reflects response and
survival. Ann Oncol. 2021;32(2):229-239.
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version on businesswire.com: https://www.businesswire.com/news/home/20230913435380/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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