AUSTIN, Texas, Jan. 22, 2022 /PRNewswire/ -- Natera, Inc.
(NASDAQ: NTRA), a leader in personalized genetic testing and
diagnostics, today announced new data recently presented on the
clinical utility of Signatera, its personalized and tumor-informed
molecular residual disease (MRD) test, at the American Society of
Clinical Oncology's 2022 Gastrointestinal Cancers Symposium (ASCO
GI). The oral presentation included an updated analysis from the
landmark CIRCULATE-Japan trial analyzing a cohort of colorectal
cancer (CRC) patients.
More than 3,000 CRC patients are
now enrolled in CIRCULATE-Japan,
the largest prospective, multi-center, MRD-guided trial in CRC,
using Signatera to monitor MRD status in patients with stage I-IV
CRC up to 96 weeks post-surgery. The latest analysis of more than
1,000 patients from the observational GALAXY arm of the study
highlighted three novel findings that were presented at the
conference:
- Signatera positivity is predictive of treatment benefit:
patients who were MRD-positive at 4 weeks post-op benefited
significantly from adjuvant chemotherapy (ACT), across all stages
of disease.
- Signatera-negative patients did not benefit from ACT: patients
with high-risk stage II and stage III disease who were MRD-negative
at 4 weeks post-op did not derive significant benefit from ACT
(p-value of .63).
- Signatera dynamics during ACT is predictive of treatment
benefit: 68% of ACT-treated patients cumulatively cleared their
ctDNA by week 24 and had significantly better outcomes relative to
those who remained ctDNA-positive, with a hazard ratio of
15.8.
In addition, the single time point post-surgical sensitivity of
Signatera in stage II and III CRC was 67.6%. This sensitivity
analysis included over 5 times more cancer recurrences than
previously reported in Reinert, et. al.1
"Definitive evidence has now been presented that personalized
MRD testing can guide adjuvant treatment decisions, particularly
for MRD-positive patients who clearly benefit from adjuvant
chemotherapy," said the CIRCULATE-Japan study's principal
investigator, Dr. Takayuki Yoshino,
of the National Cancer Center Hospital East, Kashiwa, Chiba, Japan. "We see these results as an
important step forward in establishing MRD-guided adjuvant therapy
as the standard of care for colorectal cancer patients
worldwide."
"Current guidelines recommend combination chemotherapy for all
patients with stage III CRC, yet it is known that up to 40% are
cured by surgery alone. Our study demonstrates that MRD testing can
help stratify and predict which patients are likely to benefit from
systemic therapy," said Alexey
Aleshin, M.D., VP of oncology medical affairs at Natera. "We
are extremely pleased with these groundbreaking results from
CIRCULATE-Japan and are optimistic they may change practice
guidelines."
The full presentation, as shown at ASCO GI, is available
here.
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 three 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. This maximizes
Signatera's 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. Signatera is intended to detect
and assess how much cancer is left in the body, to identify
recurrence earlier and to help optimize treatment decisions.
About Natera
Natera™ is a global leader in cell-free DNA testing, dedicated
to oncology, women's health, and organ health. Our aim is to make
personalized genetic testing and diagnostics part of the standard
of care to protect health and enable earlier and more targeted
interventions that help lead to longer, healthier lives. Natera's
tests are validated by more than 100 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 new product offerings, 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.
Contacts
Investor Relations: Mike Brophy,
CFO, Natera, Inc., 510-826-2350
Media: Kate Stabrawa,
Communications, Natera, Inc., pr@natera.com
References
- 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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/landmark-circulate-japan-study-shows-nateras-signatera-mrd-test-is-predictive-of-chemotherapy-benefit-in-colorectal-cancer-301466131.html
SOURCE Natera, Inc.