Study Shows Guardant Reveal™ Blood-Only Liquid Biopsy Test Predicts Risk for Colorectal Cancer Recurrence with Industry-Lea...
April 30 2021 - 8:05AM
Business Wire
For patients with early-stage colorectal cancer (CRC), the
presence of circulating tumor DNA (ctDNA) or minimal residual
disease (MRD) after curative intent treatment is becoming an
important prognostic biomarker for cancer recurrence, and can also
be used to evaluate the potential need for adjuvant treatment in
post-surgical patients. Until recently, tests developed to detect
MRD required tumor tissue to gain the necessary genomic information
needed to accurately identify high-risk patients. A new study led
by Massachusetts General Hospital Cancer Center and published in
Clinical Cancer Research demonstrates that Guardant Reveal, the
first blood-only liquid biopsy to identify MRD, identifies those
patients most likely to recur, with industry-leading sensitivity,
without the need for tumor tissue.1,2
The single-center, prospective study evaluated the effectiveness
of the Guardant Reveal liquid biopsy test to detect MRD in patients
with stage I-IV colorectal cancer after curative intent therapy.
Blood draws were taken one month after completion of definitive
treatment, either surgery or adjuvant therapy, and at various
surveillance or monitoring timepoints. Blood samples were analyzed
using the Guardant Reveal test, which integrates both
cancer-specific epigenomic signatures and genomic alterations,
unlike standard MRD tests which analyze only genomic
alterations.
In the primary landmark analysis (n=84), blood samples were
taken from the curative intent patient population one month (median
31.5 days) after completion of definitive treatment. In the subset
of patients with at least one year of clinical follow-up, all
patients with detectable ctDNA recurred (100% PPV). Guardant Reveal
test sensitivity and specificity were 55.6% and 100% respectively
for this single timepoint. By incorporating longitudinal
surveillance samples, sensitivity improved to 91%. Integrating
epigenomic signatures increased test sensitivity by 36% versus
using genomic alterations alone. Additionally, CEA tests, the
traditional biomarker for colorectal cancer, did not predict
recurrence in this patient cohort.
“The integration of cancer-specific epigenomic and genomic
signatures allows Guardant Reveal to detect minimal residual
disease in early-stage colorectal cancers with industry-leading
performance and without the need for tumor tissue,” said AmirAli
Talasaz, Guardant Health president. “We believe that Guardant
Reveal can be a powerful decision-making tool for oncologists
managing patients with early-stage colorectal cancer. In addition,
our blood-only approach offers a more streamlined workflow and
faster turnaround time for clinical decision making.”
“By detecting minimal residual disease after curative intent
treatment, we can have a better understanding of which
patients are at high-risk for recurrence and perhaps tailor
additional therapy,” said Aparna Parikh, MD, MPH, Gastrointestinal
Oncologist at Massachusetts General Hospital and Assistant
Professor of Medicine, Harvard Medical School. “This study
demonstrates that the incorporation of epigenomic signatures with
genomic alterations allows for Guardant Reveal to have comparable
sensitivity and specificity as tumor informed approaches, but
without the need for tumor tissue."
Tissue-dependent MRD tests have previously reported
sensitivities of 40%-50% with a single post-surgical blood draw.1,3
When looking only at the subset of patients with stage II or III
CRC in this study, Guardant Reveal had a sensitivity of 63% and a
specificity of 100% for recurrence. These data show that Guardant
Reveal can detect minimal residual disease from a simple blood
draw. In addition, the sensitivity of the test increases with
additional longitudinal blood draws, allowing for earlier detection
of recurrence in the patient surveillance setting compared with
standard imaging methods.
The Guardant Reveal test achieves industry-leading sensitivity
(91%)2 for detecting ctDNA by simultaneously interrogating genomic
and epigenomic alterations. The test accurately identifies genomic
alterations down to allele frequencies of 0.01% and effectively
filters out biological noise sources such as mutations caused by
clonal hematopoiesis. The incorporation of biologically relevant
epigenomic signatures is essential to increasing test sensitivity
in the post curative intent and surveillance patient
populations.
The publication titled, “Minimal Residual Disease Detection
using a Plasma-Only Circulating Tumor DNA Assay in Colorectal
Cancer Patients” can be found here.
About Guardant Health
Guardant Health is a leading precision oncology company focused
on helping conquer cancer globally through use of its proprietary
blood tests, vast data sets, and advanced analytics. The Guardant
Health oncology platform leverages capabilities to drive commercial
adoption, improve patient clinical outcomes and lower healthcare
costs across all stages of the cancer care continuum. Guardant
Health has commercially launched liquid biopsy-based Guardant360®,
Guardant360 CDx, and GuardantOMNI® tests for advanced stage cancer
patients, and Guardant Reveal™ test for early-stage cancer
patients. These tests fuel development of its LUNAR screening
program, which aims to address the needs of asymptomatic
individuals eligible for cancer screening and individuals at a
higher risk for developing cancer with early detection.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of federal securities laws, including statements
regarding the potential scope, impact or benefit of Guardant Health
liquid biopsies which involve risks and uncertainties that could
cause the actual results to differ materially from the anticipated
results and expectations expressed in these forward-looking
statements. These statements are based on current expectations,
forecasts and assumptions, and actual outcomes and results could
differ materially from these statements due to a number of factors.
These and additional risks and uncertainties that could affect
Guardant Health’s financial and operating results and cause actual
results to differ materially from those indicated by the
forward-looking statements made in this press release include those
discussed under the captions “Risk Factors” and “Management’s
Discussion and Analysis of Financial Condition and Results of
Operation” and elsewhere in its Annual Report on Form 10-K for the
year ended December 31, 2020 as well as in its other reports filed
with the Securities and Exchange Commission, including, when filed,
its Quarterly Report on Form 10-Q for the period ended March 31,
2021. The forward-looking statements in this press release are
based on information available to Guardant Health as of the date
hereof, and Guardant Health disclaims any obligation to update any
forward-looking statements provided to reflect any change in its
expectations or any change in events, conditions, or circumstances
on which any such statement is based, except as required by law.
These forward-looking statements should not be relied upon as
representing Guardant Health’s views as of any date subsequent to
the date of this press release.
REFERENCES
1. 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 Oncology. 2019; 5 (8):
1125-1131.
2. Parikh A, Van Seventer E, Siravegna G, Hartwig A, et al
Minimal Residual Disease Detection using a Plasma-Only Circulating
Tumor DNA Assay in Colorectal Cancer Patients. Clinical Cancer
Research.
3. Tie J, Wang Y, Tomasetti C, Li L, Springer S, et al.
Circulating tumor DNA analysis detects minimal residual disease and
predicts recurrence in patients with stage II colon cancer. Science
Translational Medicine. 2016; 8 (346): 346ra92.
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