New MultiCenter Prospective Study Demonstrates Signatera’s Clinical Utility in Merkel Cell Carcinoma
26 Juli 2024 - 2:00PM
Business Wire
Study reports high accuracy of Signatera for
surveillance of MCC patients, suggests potential to reduce
frequency of surveillance imaging
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
testing, today announced a new study published in the Journal of
Clinical Oncology highlighting the utility of its personalized and
tumor-informed molecular residual disease (MRD) test, Signatera,
for surveillance in Merkel cell carcinoma (MCC). The full study can
be found here.
MCC is an aggressive skin cancer with high mortality and a
recurrence rate of 40% within 5 years.1 MRD testing using a viral
antibody is recommended by the National Comprehensive Cancer
Network (NCCN)2, but this tumor marker is only present in 52% of
patients and has several known limitations3-4. There is an unmet
need for improved MRD testing technologies that are applicable to
all patients, regardless of their viral status.
This prospective, multicenter, observational study included 319
patients with stage I-IV MCC. Signatera was used to assess ctDNA
levels at the time of enrollment, and every 3 months during the
surveillance period. Key findings include:
- Signatera showed a test sensitivity of approximately 95% for
detecting clinically evident disease at time of enrollment.
- ctDNA positivity during surveillance was associated with up to
20 times higher risk of recurrence than persistently ctDNA-negative
patients.
- At 12 months of surveillance, the recurrence-free probability
was 9% among patients with a positive ctDNA result at any time,
compared with 91% for patients who remained ctDNA-negative.
“There is a strong need for highly accurate biomarkers in merkel
cell carcinoma, an incredibly aggressive and rare form of skin
cancer,” said Lisa Zaba, M.D., Ph.D., associate professor of
dermatology, director of the MCC multi-disciplinary clinic and
member of the supportive oncodermatology group at the Stanford
Cancer Center. “Our study shows that a tumor-informed MRD test can
inform prognosis and guide surveillance in patients with MCC,
regardless of tumor viral status.”
“We are encouraged by the excellent performance of Signatera in
this study, where high prognostic accuracy was demonstrated, and
where we can see the significant clinical utility of MRD testing
for detecting recurrence in MCC patients,” said Angel Rodriguez,
M.D., senior medical director at Natera and co-author of the study.
“We are optimistic that Signatera will become a standard monitoring
tool in this highly lethal cancer type, enabling clinicians to
select patients with MRD who might benefit most from adjuvant
therapy and better determine who may or may not need more frequent
imaging with a high degree of confidence.”
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 70 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 validated by more than 200 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
- McEvoy AM, Lachance K, Hippe DS, et al. Recurrence and
Mortality Risk of Merkel Cell Carcinoma by Cancer Stage and Time
From Diagnosis. JAMA Dermatol. 2022;158(4):382-389.
- NCCN Clinical Practice Guidelines in Oncology (NCCN
Guidelines®) for Merkel Cell Carcinoma Version 1.2024. © National
Comprehensive Cancer Network, Inc. 2024. All rights reserved.
Accessed March 25, 2024.
- Paulson KG, Lewis CW, Redman MW, et al. Viral oncoprotein
antibodies as a marker for recurrence of Merkel cell carcinoma: A
prospective validation study. Cancer. 2017;123(8):1464-1474.
- Paulson KG, Carter JJ, Johnson LG, et al. Antibodies to merkel
cell polyomavirus T antigen oncoproteins reflect tumor burden in
merkel cell carcinoma patients. Cancer Res.
2010;70(21):8388-97.
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version on businesswire.com: https://www.businesswire.com/news/home/20240726557773/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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