Natera Announces New Study Highlighting the Benefits of Signatera’s Unique Method of Quantifying ctDNA
21 Dezembro 2023 - 10:00AM
Business Wire
Pan-cancer study showed MTM/mL dynamics were
more predictive of therapy response than mVAF dynamics, with an
observed hazard ratio nearly 2x higher
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
testing, today announced a new study published in Molecular
Oncology comparing the performance of mean tumor molecules per
milliliter (MTM/mL) against mean variant allele frequency (mVAF)
for measuring circulating tumor DNA (ctDNA), using Signatera™,
Natera’s personalized and tumor-informed molecular residual disease
(MRD) test. The full study can be found here.
To date, mVAF and MTM/mL are the two main metrics that have been
used to quantify ctDNA levels in the blood. Unlike mVAF, which is a
fraction that can be confounded by changes in total background
cfDNA, MTM/mL takes into account total cfDNA as well as plasma
volume. The premise is that MTM/mL is therefore more representative
of a patient’s true disease burden, a hypothesis that was validated
in this study.
The study analyzed ctDNA data generated in 55,183 ctDNA-positive
samples from 23,543 patients who underwent testing with Signatera
for various cancer diagnoses, and it reported the correlation
between MTM/mL and mVAF, as well as the correlations of each with
patient outcomes.
Key findings include:
- Among the 18,426 patients with longitudinal ctDNA measurements,
13.3% had discordant ctDNA trajectories (increase/decrease) when
calculated using MTM/mL versus mVAF.
- In patients with stage IV disease receiving immunotherapy
(N=51), ctDNA dynamics measured in MTM/mL were more predictive of
therapy response than those measured in mVAF, with a hazard ratio
(HR) nearly 2x higher (MTM/mL HR 16, p<0.0001; mVAF HR 8.8,
p<0.0001).
- In a case study of a patient with metastatic triple-negative
breast cancer, disease progression during systemic therapy was
reflected in increasing MTM/mL values, while mVAF levels remained
stable.
“We are pleased to see the publication of these important
findings, in which MTM/mL provided a more accurate measure of ctDNA
than mVAF, particularly for patients undergoing active therapy
which can impact the levels of background cfDNA,” said Minetta Liu,
M.D., chief medical officer of oncology at Natera. “Clinicians need
tools to enable reliable predictions of therapy response and
clinical outcomes. As the only MRD test that uses MTM/mL, this
study supports the utility of Signatera for ctDNA quantification,
to measure treatment response at critical time points and inform
decisions on how patients are managed.”
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 (stage IIb and higher) 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 50 peer-reviewed papers.
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 180 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20231221683887/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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