- New Guardant360 Response™ blood test predicts treatment
response to immunotherapy and targeted therapy, up to eight weeks
earlier than standard-of-care RECIST methods1-11
- New Guardant360 TissueNext™ tissue biopsy test is now available
for ordering alongside the Guardant360® CDx blood test, providing
oncologists an efficient “blood-first, tissue-next” approach for
complete genomic testing
Guardant Health, Inc. (Nasdaq: GH) adds two new products to its
portfolio to help improve the management of patients with
late-stage and metastatic cancers. The Guardant360 Response™ test
represents a breakthrough as the first commercially available,
blood-only, liquid biopsy test that detects changes in circulating
tumor DNA (ctDNA) levels to provide oncologists an early indication
of a patient’s response to treatment. The Guardant360 TissueNext™
test, the company’s first tissue-based test, is now available, if
needed, to help oncologists identify patients with advanced cancer
who may benefit from biomarker-informed treatment.
Both products expand on the trusted
Guardant360® portfolio to offer oncologists end-to-end testing
solutions, covering treatment selection, with the option of
ordering tissue biopsy results if needed, and treatment response
monitoring, to help improve clinical outcomes for patients with
advanced cancer.
The Guardant360 Response liquid
biopsy test detects changes in ctDNA levels from a simple blood
draw, to assess treatment response up to eight weeks earlier than
RECIST (Response Evaluation Criteria in Solid Tumors),1-11 giving
oncologists a new tool to use when considering whether to continue,
stop, or explore other treatment options for their patients with
late-stage or metastatic cancer. Molecular responders (those with
decreasing ctDNA levels) show significantly longer progression-free
and overall survival rates, compared to molecular
non-responders.1-12 In over 50 studies, Guardant Health has
demonstrated that molecular response, as measured by changes in
ctDNA levels, can help provide an early indication of treatment
response across therapies (targeted, immunotherapy, and
chemotherapy) and cancer types including non-small cell lung,
colorectal, breast, and bladder.1-12
“Using circulating tumor DNA levels to monitor treatment
response is a promising new approach in the management of patients
with advanced cancer,” said Craig Eagle, MD, Guardant Health Chief
Medical Officer. “We are delighted to offer oncologists a simple
blood test that can provide an early assessment of whether their
patient is responding to treatment, or not. Multiple studies using
the Guardant360 Response test have shown that molecular response,
as measured by circulating tumor DNA levels, can help predict
clinical benefit, and longer progression-free survival.”
The Guardant360 TissueNext test can now be ordered, alongside
the Guardant360 CDx blood test, to prepare for cases when the
Guardant360 CDx test does not find actionable biomarkers. While
starting with the Guardant360 CDx blood test to perform complete
genomic testing finds nearly 80 percent of patients with actionable
biomarkers in only seven days,13-15 compared to finding only 50
percent of patients when starting with a tissue biopsy, and which
can take two to four times longer,13-15 there are cases when
results are needed from a tissue biopsy. The new Guardant360
TissueNext test offers oncologists the most efficient “blood-first,
tissue-next” workflow to complete genomic testing, ensuring that as
many patients as possible are identified who may benefit from
biomarker-informed treatment.
“With the new Guardant360 Response blood test, we are excited to
offer a cutting-edge test able to predict patient response to
treatment sooner than standard radiographic assessment, to help
inform clinical decisions and improve outcomes,” said Helmy
Eltoukhy, Guardant Health CEO. “By broadening our Guardant360
portfolio to cover not only treatment selection but treatment
response, we provide oncologists a more complete view of their
patient’s tumor evolution and resistance to interventional
therapies, including immunotherapies. Furthermore, while starting
with the Guardant360 CDx liquid biopsy for biomarker testing is
shown to be more efficient than starting with an invasive tissue
biopsy13-15 which has a longer turn-around time to return results,
the addition of our new Guardant360 TissueNext test strengthens our
treatment selection offering, by providing oncologists the benefits
of ‘blood-first, tissue-next’ testing options to find as many
patients as possible, who may benefit from biomarker-informed
treatment.”
The Guardant360 CDx test, the new Guardant360 TissueNext test,
and the new Guardant360 Response test are all part of the
Guardant360 portfolio, which provides oncologists a more complete
genomic picture across the treatment journey. This comprehensive
set of cancer tests empowers oncologists to optimize treatment, and
know confidently what to do next. From fast treatment selection,
starting first with the FDA-approved Guardant360 CDx test, to
reflex testing with the Guardant360 TissueNext test, if needed, to
early treatment response monitoring with the Guardant360 Response
test, the Guardant360 portfolio helps oncologists unlock the full
potential of precision oncology for their patients with late-stage
and metastatic cancers.
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, Guardant360 TissueNext™, Guardant360 Response™,
and GuardantOMNI® tests for advanced stage cancer patients, and
Guardant Reveal™ 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.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of federal securities laws, including statements
regarding the potential utilities, values, benefits and advantages
of Guardant Health’s liquid biopsy tests or assays, 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 and in its
other reports filed with the Securities and Exchange Commission,
including 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.
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Reduction in ctDNA Predicts Survival in Patients with Lung and
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2. Aggarwal C, Thompson JC, Chien A, et al. Dynamic monitoring
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8. Modi S, Park H, Murthy RK, et al. Antitumor Activity and
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Investor Contact: Carrie Mendivil
investors@guardanthealth.com Media Contacts: Anna Czene
press@guardanthealth.com Julie Johnson
julie.johnson@uncappedcommunications.com
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