SAN CARLOS, Calif.,
Sept. 24, 2020 /PRNewswire/
-- Natera, Inc. (NASDAQ: NTRA), a pioneer and global
leader in cell-free DNA testing, today announced that the CMS
Molecular Diagnostics Program (MOLDX) has issued a draft local
coverage determination (LCD) to provide expanded coverage for
circulating tumor DNA (ctDNA) tests that detect MRD in patients
with a history of cancer. In particular, the proposed expansion
would cover the Signatera MRD test for immunotherapy response
monitoring. The LCD is posted here on the Centers for Medicare
and Medicaid Services website.
The proposed LCD follows Medicare's recent final coverage
decision in colorectal cancer released earlier this month. In its
description of the IO monitoring indication, the draft LCD
specifically references Signatera and the pan-cancer validation
study recently published in Nature Cancer.1 In
that study, Signatera identified treatment non-responders with a
100% positive predictive value, when used in conjunction with
imaging.
In addition, the draft LCD creates a pathway for coverage of
Signatera in additional solid tumor types and indications, where it
is clinically validated with peer-reviewed evidence and where the
clinical utility is established. Signatera has been validated
across multiple cancer types to detect residual disease up to 2
years earlier than standard diagnostic tools.2-5
"Medicare's proposed coverage offers enormous benefit to the
over 200,000 patients being treated with immune checkpoint
inhibitors,6" said Solomon
Moshkevich, General Manager of Oncology at Natera. "We look
forward to working with the oncology community to generate further
evidence supporting the clinical value of Signatera in both
early-stage and advanced-stage cancers."
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. Signatera has been developed and its
performance characteristics determined by Natera, the
CLIA-certified laboratory performing the test. The test has not
been cleared or approved by the US Food and Drug Administration
(FDA). CAP accredited, ISO 13485 certified, and CLIA certified.
About Natera
Natera is a pioneer and global
leader in cell-free DNA testing. The mission of the company is to
change the management of disease worldwide with a focus on women's
health, oncology, and organ health. Natera operates an ISO
13485-certified and CAP-accredited laboratory certified under the
Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, California. 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, whether the results of clinical or other studies will
support the use of our product offerings, our ability to
successfully increase demand for and grow revenues for our product
offerings, our expectations regarding the reliability, accuracy and
performance of our screening tests, or regarding the benefits of
our screening tests and product offerings to patients, providers
and payers, or coverage and reimbursement determinations from
third-party 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
- Bratman SV, Yang SYC, Iafolla MAJ, et al. Personalized
circulating tumor DNA analysis as a predictive biomarker in solid
tumor patients treated with pembrolizumab. Nat. Cancer.
2020.
- 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.
- IQVIA™ Institute for Human Data Science Releases Global
Oncology Trends 2019 Study: Record Number of Cancer Drugs Launched
in 2018 across 17 Indications. IQVIA.
https://www.iqvia.com/newsroom/2019/05/iqvia-institute-for-human-data-science-releases-global-oncology-trends-2019-study-record-number-of-c.
Published 2019.
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SOURCE Natera, Inc.