Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
testing, today announced that its personalized and tumor-informed
molecular residual disease (MRD) test, Signatera, has met coverage
requirements from the Centers for Medicare & Medicaid Services’
(CMS) Molecular Diagnostics Services Program (MolDX) in two new
indications: ovarian cancer in the adjuvant and surveillance
settings, and breast cancer in the neoadjuvant setting.
These determinations add to a growing list of covered
indications for Signatera, including adjuvant and recurrence
monitoring coverage in colorectal cancer, muscle-invasive bladder
cancer, and breast cancer; and pan-cancer immunotherapy response
monitoring.
Ovarian Cancer
The MolDX coverage decision applies to patients with ovarian
cancer, in both the adjuvant and surveillance settings.
Ovarian cancer is the 5th leading cause of cancer-related death
among women, with an estimated 2022 incidence and mortality of
19,880 and 12,810, respectively, and a median age at diagnosis of
63 years.1 While multiple new treatment options have been
introduced in recent years, physicians have had to rely on
imperfect biomarkers to determine who is likely to benefit from
these more intensive regimens, and recurrence risk remains high2.
Additionally, current guidelines for surveillance are limited and
providers often rely on tools with low sensitivity and specificity,
such that a significant unmet need remains for these patients.3
Signatera performance in ovarian cancer was validated in a
blinded, multi-site study published in Gynecologic Oncology.4 The
study analyzed 163 plasma samples from 69 patients with stage I-IV
ovarian cancer. Test performance was evaluated at multiple time
points: pre-surgery, post-surgery prior to adjuvant treatment, and
longitudinally. With longitudinal testing, recurrence was detected
with 100% sensitivity, 100% specificity, and an average lead time
of 10 months ahead of imaging.
Breast Cancer (neoadjuvant
setting)
This MolDx coverage decision applies to patients with breast
cancer in the neoadjuvant setting across all subtypes of the
disease, including hormone receptor (HR)-positive, HER2-positive,
and triple negative breast cancers.
Up to 50% of newly diagnosed breast cancer patients receive
neoadjuvant therapy (NAT).5 Guidelines recommend routine assessment
of tumor response to neoadjuvant therapy but acknowledge that this
is “difficult” using currently available diagnostic tools.6
Signatera has been validated to address this unmet need.
The coverage decision was based on clinical evidence published
in Cancer Cell7 from the I-SPY2 trial, which reported on 283
patients and 1,024 plasma samples, with a median of more than 3
years of clinical follow up and a maximum of more than 7.5 years.
The study demonstrated that early ctDNA clearance during NAT was a
significant predictor of therapy response (p=0.0002), and Signatera
negativity after NAT was significantly associated with improved
distant recurrence-free survival (DRFS), even in patients with
residual cancer burden at surgery (p<0.0001). By contrast,
persistent Signatera positivity during and after NAT was
significantly associated with therapy non-response and inferior
DRFS (p=0.02 to p<0.0001).
“These important Medicare decisions support our ability to
personalize disease management for patients with ovarian cancer,
the most lethal gynecologic malignancy worldwide, and extend
existing coverage in breast cancer to the neoadjuvant setting,”
said Minetta Liu, M.D., chief medical officer of oncology at
Natera. “Clinical evidence continues to demonstrate the value of
Signatera across various settings of disease, which can help
clinicians make timely decisions and may improve outcomes for
patients. We are incredibly proud of this milestone, and look
forward to continuing to work with Medicare to make Signatera more
widely accessible for people affected by cancer.”
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 65 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 in approximately 175 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
- American Cancer Society. Key Statistics for Ovarian Cancer.
https://www.cancer.org/cancer/types/ovarian-cancer/about/key-statistics.html
- Ovarian Cancer Research Alliance. Recurrence.
https://ocrahope.org/patients/diagnosis-and-treatment/recurrence/#:~:text=Data%20has%20shown%20that%20statistically,periods%20of%20time%20after%20recurrence.
- NCCN Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal
Cancer Treatment Guidelines. V1.2024 - Jan 17, 2024.
- Hou JY, Chapman JS, Kalashnikova E, et al. Circulating tumor
DNA monitoring for early recurrence detection in epithelial ovarian
cancer. Gynecol Oncol. 2022;167:334-341. (doi:
10.1016/j.ygyno.2022.09.004).
- Riedel F, Hoffmann AS, Moderow M, et al. Time trends of
neoadjuvant chemotherapy for early breast cancer. Int J Cancer.
2020;147(11):3049–3058.
- National Comprehensive Cancer Network (NCCN). Version 1.2024,
Jan 25, 2024.
- Magbanua MJM, Swigart LB, Ahmed Z, et al. Clinical significance
and biology of circulating tumor DNA in high-risk early-stage
HER2-negative breast cancer receiving neoadjuvant chemotherapy.
Cancer Cell. 2023;41:1-12.
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version on businesswire.com: https://www.businesswire.com/news/home/20240226912876/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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