SAN CARLOS, Calif.,
April 2, 2020 /PRNewswire/ --
A new, peer-reviewed case study published in JCO Precision
Oncology1 demonstrates the unique ability of
Signatera technology to detect esophageal cancer recurrence almost
one year before current standards of care, using a simple blood
draw to monitor for traces of circulating tumor DNA (ctDNA). This
report builds upon a fast-growing body of scientific evidence
behind the Signatera test across multiple cancer types.
The study follows a 72-year old man with recurrent Stage III
esophageal cancer whose recurrence was detected 350 days before
radiographic imaging, using Signatera's personalized and
tumor-informed technology. After undergoing multiple CT scans
showing no signs of cancer, the patient's physicians escalated to a
PET scan, which revealed a 4 cm nodule in his liver that was later
surgically removed. The full study can be found here.
"This case study illustrates the potential advantage of using
personalized ctDNA testing as a surveillance tool, especially in
the current environment with COVID-19," commented senior author
Eirini Pectasides, M.D., Ph.D., a medical oncologist specializing
in gastrointestinal cancer at Dana-Farber Cancer Institute and
instructor in medicine at Harvard Medical
School.
In the era of COVID-19 and social distancing, where cancer
patients are among those with the highest risk of mortality from
exposure to the virus, many oncologists are cancelling routine
surveillance visits and looking for remote monitoring solutions. In
response to the pandemic, Natera has announced a temporary GI
Cancer Expanded Access Program that offers compassionate use of the
Signatera test for patients with any form of GI cancer through
July 31, 2020, including esophageal
cancer, which was the focus of the case study. Details of the
Expanded Access Program can be found here.
"Patient anxiety around cancer recurrence can be immense,"
commented Solomon Moshkevich,
General Manager of Natera's Oncology business. "This case
exemplifies the value of early recurrence detection, through blood
testing that can be accessed remotely from one's home."
Signatera has been validated across multiple cancer types to
detect molecular residual disease (MRD) up to 2 years earlier than
standard diagnostic tools,2-5 with virtually no false
positives (< 0.3%).3 While a negative test result
does not mean someone is definitely cancer-free, it does mean the
risk of relapse is significantly reduced. These results, in
conjunction with clinical and pathological risk assessment, may
help patients avoid treatment with chemotherapy that can weaken the
immune system.
More 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 clinical and research use, and in 2019, it was
granted Breakthrough Device Designation by the FDA. 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. This
maximizes accuracy for detecting the presence or absence of
residual disease in a blood sample, even at levels down to a single
tumor molecule in a tube of blood. Unlike a standard liquid biopsy,
Signatera is not intended to match patients with any particular
therapy; rather, it is intended to detect and quantify how much
cancer is left in the body, to detect recurrence earlier and to
help optimize treatment decisions. Signatera test performance has
been clinically validated in multiple cancer types including
colorectal, non-small cell lung, breast, and bladder cancers.
Medicare has proposed insurance coverage for the use of Signatera
in patients with Stage II or III colorectal cancer, and it is
expected to finalize that coverage decision in mid-2020.
Signatera was developed by Natera, Inc. a laboratory certified
under the Clinical Laboratory Improvement Amendments (CLIA). This
test has not been cleared or approved by the U.S. Food and Drug
Administration (FDA). Although FDA does not currently clear or
approve laboratory-developed tests in the U.S., certification of
the laboratory is required under CLIA to ensure the quality and
validity of the tests.
About Natera
Natera is a global leader in cell-free DNA testing. The
mission of the company is to change the management of disease
worldwide with a focus on reproductive health, oncology, and organ
transplantation. Natera operates an ISO 13485-certified and
CAP-accredited laboratory certified under the Clinical Laboratory
Improvement Amendments (CLIA) in San
Carlos, Calif. It offers proprietary genetic testing
services to inform obstetricians, transplant physicians,
oncologists, and cancer researchers, including biopharmaceutical
companies, and genetic laboratories through its cloud-based
software platform. For more information, visit natera.com. Follow
Natera on LinkedIn.
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 our efforts to develop and
commercialize new product offerings, our ability to successfully
increase demand for and grow revenues for our product offerings,
whether the results of clinical or other studies will support the
use of our product offerings, our expectations of the reliability,
accuracy and performance of our screening tests, or of the benefits
of our screening 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.
Contacts
Investor Relations: Mike Brophy,
CFO, Natera, Inc., 650-249-9090
Media: Paul Greenland, VP of
Corporate Marketing, pr@natera.com
References:
- Einstein DJ, Liang N, Malhotra M, et al. Assessment of
molecular remission in oligometastatic esophageal cancer with a
personalized circulating tumor DNA assay. JCO PO.
2020;4:239-243.
- Reinert T, Henriksen TV, Christensen E, et al. Analysis of
plasma cell-free DNA by ultradeep sequencing in patients with
stages I to III colorectal cancer. JAMA Oncol.
2019;5(8):1124–1131.
- Coombes RC, Page K, Salari R, et al. Personalized detection of
circulating tumor DNA antedates breast cancer metastatic
recurrence. Clin Cancer Res.
2019;25(14):4255-426.
- Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA
analysis depicts early-stage lung cancer evolution. Nature.
2017;545(7655):446-451.
- Christensen E, Birkenskamp-Demtroder K, Sethi H, et al. Early
detection of metastatic relapse and monitoring of therapeutic
efficacy by ultra-deep sequencing of plasma cell-free DNA in
patients with urothelial bladder carcinoma. J Clin Oncol.
2019; 37(18):1547-1557.
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SOURCE Natera, Inc.