Guardant Health Presents Data at AACR Virtual Annual Meeting II Showing Liquid Biopsy Highly Accurate in Detecting Early-Stag...
22 June 2020 - 11:05PM
Guardant Health, Inc. (Nasdaq: GH), a leading precision
oncology company, presents new data at the American Association for
Cancer Research (AACR) Virtual Annual Meeting II demonstrating that
its LUNAR-2 liquid biopsy is a highly sensitive test that can
detect early-stage colorectal cancer (CRC).
The data presented show that the LUNAR-2 assay
achieved 90% sensitivity and 94% specificity in detecting
early-stage CRC.1 When restricting analysis of the controls to
those who were negative for CRC by colonoscopy (n=74), the LUNAR-2
assay demonstrated improved specificity (99%) with no reduction in
sensitivity. These results are consistent with previously reported
data2 showing that the company’s multi-modal, cancer-specific
circulating tumor DNA (ctDNA) technology increases test sensitivity
to deliver clinically meaningful results.
“Colorectal cancer remains a leading cause of
cancer-related death, yet it is estimated that nearly 1 in 3
American adults are not up to date with screening recommendations
despite the availability of colonoscopies and stool-based testing.
Our LUNAR-2 assay holds the promise to directly improve cancer
screening rates by addressing patient non-compliance with a simple
blood test. This study confirms that our test can consistently
detect early-stage colorectal cancer,” said Dr. Kathryn Lang,
Guardant Health Vice President of Outcomes and Evidence.
“Additionally, in light of COVID-19 and the associated challenges
of performing invasive procedures, the need for highly sensitive
screening tests that are easy to administer are more important than
ever.”
The LUNAR-2 assay is currently being evaluated
in a large-scale, registrational trial, ECLIPSE (NCT04136002), to
detect CRC in average-risk adults.
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 launched liquid
biopsy-based Guardant360 and GuardantOMNI tests for advanced stage
cancer patients. These tests fuel development of its LUNAR program,
which aims to address the needs of early stage cancer patients with
neoadjuvant and adjuvant treatment selection, cancer survivors with
surveillance, 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 benefits and advantages of
Guardant Health’s LUNAR-2 assay, 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. Such risks and uncertainties
include those discussed under the caption “Risk Factors” in
Guardant Health’s Annual Report on Form 10-K for the year
ended December 31, 2019, its Quarterly Report on Form 10-Q for
the period ended March 31, 2020, and in its other reports filed
with the Securities and Exchange Commission. These
forward-looking statements are based on current expectations,
forecasts, assumptions and information available to Guardant
Health as of the date hereof, and actual outcomes and results
could differ materially from these statements due to a number of
factors, 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. Investors are urged
not to rely on any forward-looking statement in reaching any
conclusion or making any investment decision about any securities
of Guardant Health.
Investor Contact: Carrie Mendivil
investors@guardanthealth.com
Media Contact: Anna Czene
press@guardanthealth.com Becky Lauer
becky.lauer@uncappedcommunications.com
REFERENCES
- Westesson O, Axelrod, H, Dean J, et al. Integrated
genomic and epigenomic cell-free DNA (cfDNA) analysis for the
detection of early-stage colorectal cancer (CRC). Poster presented
at AACR Virtual Annual Meeting II, June 22-24, 2020.
- Kim ST, Raymond VM, Park JO, et al. Combined genomic and
epigenomic assessment of cell-free circulating tumour DNA (ctDNA)
improves assay sensitivity in early stage colorectal cancer
(CRC). Proceedings: AACR Annual Meeting 2019; March
29-April 3, 2019; Atlanta, GA, DOI:
10.1158/1538-7445.AM2019-91
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