Natera Submits First PMA Module to the FDA for Signatera™
02 Outubro 2023 - 10:00AM
Business Wire
Lays groundwork for multiple submissions across
cancer types, starting with CDx label in bladder cancer
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
testing, today announced the submission of the first module of its
premarket approval (PMA) application to the U.S. Food and Drug
Administration (FDA) for Signatera, Natera’s personalized and
tumor-informed molecular residual disease (MRD) test, as a
companion diagnostic (CDx) assay for patients with muscle-invasive
bladder cancer (MIBC).
This module, submitted on September 28, included the required
documentation regarding Natera’s manufacturing and quality control
systems, which the Company expects will support all future
indications for Signatera as well as other Natera products. The
remaining modules for the Signatera MIBC indication, including
software, analytical and clinical validation data, are expected to
be submitted through 2025 upon completion of the ongoing
registrational trial.
“With this initial step towards a PMA for Signatera, we are
continuing to build on our longstanding engagement with the FDA,”
said Steve Chapman, chief executive officer of Natera. “This
milestone reflects the significant efforts of our team in
developing an FDA-grade quality and manufacturing system, a strong
foundation designed to support future regulatory submissions across
disease indications for Signatera and across product lines.”
Signatera has previously been granted four Breakthrough Device
Designations by the FDA, including the CDx claim in MIBC submitted
in the PMA module package.
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 help
identify recurrence earlier and 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 our
efforts to develop and commercialize our product offerings, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231002107347/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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