New Natera Publication Bolsters Evidence for Extended Surveillance with Signatera™ in Breast Cancer
03 Mayo 2024 - 7:00AM
Business Wire
Expanded EBLIS study with up to 12 years of
clinical follow-up across all subtypes of breast cancer
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
and genetic testing, today announced a new publication in JCO
Precision Oncology reporting on the ability of its personalized and
tumor-informed molecular residual disease (MRD) test, Signatera, to
detect recurrence early in patients with early-stage breast cancer.
The full study can be found here.
The study evaluated a total of 1,136 prospectively collected and
banked plasma samples from 156 early-stage breast cancer patients
enrolled in the multi-site Exploratory Breast Lead Interval Study
(EBLIS). Patients were followed for up to 12 years after surgery
and adjuvant chemotherapy, with blood samples collected
semi-annually and then analyzed using Signatera. Key findings
include:
- Signatera detected relapse up to 38 months earlier than imaging
(median lead time 10.5 months), with an overall sensitivity of
88.2% (30/34)
- Relapse-free survival (RFS) and overall survival (OS) were
significantly worse in patients who were ctDNA-positive, regardless
of hormone receptor and HER2 subtype (HR 52.98 and 53.69,
respectively). In a multivariate analysis, ctDNA status was the
most significant factor associated with RFS and OS.
“The EBLIS study shows that post-operative monitoring with
Signatera can detect recurrence much earlier than scans, opening up
a critical window for early therapeutic intervention and clinical
trials focused on molecular recurrence,” said Charles Coombes, MD,
PhD professor of medical oncology at the Imperial College London
and principal investigator of the EBLIS study. “Additionally, we
demonstrate the value of longitudinal testing in providing
reassurance to breast cancer patients, as those who test serially
ctDNA-negative show better clinical outcomes.”
Breast cancer is the most common cancer in women in the U.S. and
the second leading cause of cancer death in women.1 The current
standard of care for most patients with early-stage breast cancer
consists of surgery and adjuvant chemotherapy and/or endocrine
therapy.2,3 However, patients with early-stage breast cancer
experience a rate of local recurrence of roughly 15% and distant
metastases of 21% after primary treatment.4
“This expanded EBLIS study reinforces the importance of early
recurrence detection with Signatera and the potential to improve
care management for patients with breast cancer,” said Minetta Liu,
MD, chief medical officer of oncology. “The findings also bolster
the evidence for long-term monitoring of high-risk breast cancer
patients, who often face late recurrences.”
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 is covered by Medicare for patients with
colorectal cancer, breast cancer, ovarian cancer and muscle
invasive bladder cancer, as well as for immunotherapy monitoring of
any solid tumor. Signatera has been clinically validated across
multiple cancer types and indications, with published evidence in
more than 60 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 supported by more than 200 peer-reviewed
publications that demonstrate excellent performance. 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
- American Cancer Society. Cancer Facts and Figures 2024.
Atlanta: American Cancer Society; 2024.
- Gradishar WJ, Moran MS, Abraham J, et al. NCCN Guidelines®
Insights: Breast Cancer, Version 4.2023. J Natl Compr Canc Netw.
2023;21(6):594-608.
- Senkus E, Kyriakides S, Ohno S et al. Primary breast cancer:
ESMO Clinical Practice Guidelines for diagnosis, treatment and
follow-up. Ann Oncol 2015;26 Suppl 5: v8-30.
- Lyngholm CD, Laurberg T, Alsner J, Damsgaard TE, Overgaard J,
Christiansen PM. Failure pattern and survival after breast
conserving therapy. Long-term results of the Danish Breast Cancer
Group (DBCG) 89 TM cohort. Acta Oncol. 2016;55(8):983-92.
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version on businesswire.com: https://www.businesswire.com/news/home/20240503118111/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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