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Guardant Health Receives Medicare Coverage for Guardant360 Response™ to Monitor Cancer Patient Response to Immunotherapy
Rhea-AI Impact
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Rhea-AI Sentiment
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Rhea-AI Summary
Guardant Health (Nasdaq: GH) announced that the Guardant360 Response test is now covered for U.S. Medicare patients with metastatic or inoperable solid tumors undergoing immune checkpoint inhibitor therapy. This coverage allows for monitoring molecular response through circulating tumor DNA (ctDNA) changes, providing early indications of treatment effectiveness. Patients will receive the Guardant360 CDx or LDT test to establish a ctDNA baseline before therapy and a Guardant360 Response test 4 to 10 weeks post-initiation to assess changes. This significant policy expansion follows previous Medicare coverages for other Guardant Health tests, enhancing the company's offerings and supporting oncologists in making informed treatment decisions.
Positive
Medicare coverage for the Guardant360 Response test enhances treatment monitoring for cancer patients.
The test provides early indications of patient response to immune checkpoint inhibitors, potentially improving clinical outcomes.
This coverage adds to existing Medicare coverage of Guardant Health products, signaling strong recognition of its testing capabilities.
Negative
None.
First blood-only liquid biopsy test for monitoring molecular response to immune checkpoint inhibitors now covered for US Medicare patients with metastatic or inoperable solid tumors
PALO ALTO, Calif.--(BUSINESS WIRE)--
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today that Palmetto GBA, a Medicare administrative contractor for the Molecular Diagnostics Services program (MolDX), has conveyed coverage for the Guardant360 Response test. Guardant360 Response is the first blood-only test that enables doctors to track molecular response through changes in circulating tumor DNA (ctDNA) levels, to get an early indication of metastatic or advanced cancer patient response to immune checkpoint inhibitor therapy.
Following this decision, the Guardant360 Response test is now covered for fee-for-service Medicare patients in the U.S. with metastatic or inoperable solid tumors who are on an immune checkpoint inhibitor therapy. The coverage includes a Guardant360 CDx or LDT test before initiating therapy to establish a ctDNA baseline and a Guardant360 Response test 4 to 10 weeks after the therapy has been initiated to measure the change in ctDNA level.
“We are pleased that Medicare has taken this important step to make treatment response monitoring more widely available in order to assist oncologists in making more informed therapeutic decisions for their patients with solid tumor cancers,” said Helmy Eltoukhy, Guardant Health co-CEO.
This policy decision adds to the existing Medicare coverage of Guardant Health tests for cancer patients. In December 2019, Palmetto GBA expanded local coverage determination (LCD) of the Guardant360® assay, making it the first liquid biopsy to be broadly covered for use across the vast majority of advanced solid tumors. In March 2022, Palmetto GBA conveyed coverage for Guardant360 TissueNext™, the company’s first tissue-based test to help oncologists identify patients with advanced cancer who may benefit from biomarker-informed treatment. In July 2022, coverage was granted for Guardant Reveal™, a molecular residual disease (MRD) test to identify cancer patients with residual or recurring stage II or III colorectal cancer who may benefit most from adjuvant therapy.
About Guardant Health
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary 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 Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantINFINITY™ tests for advanced-stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the commercially launched Shield™ test, aims to address the needs of individuals eligible for cancer screening. For more information, visit guardanthealth.com and follow the company on LinkedIn and Twitter.
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, 2022, and any current and periodic reports filed with or furnished to the Securities and Exchange Commission thereafter. 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.
What is the Guardant360 Response test covered by Medicare for?
The Guardant360 Response test is covered by Medicare for monitoring molecular response in patients with metastatic or inoperable solid tumors receiving immune checkpoint inhibitor therapy.
When did Medicare start covering the Guardant360 Response test?
Medicare coverage for the Guardant360 Response test was announced recently, providing access for relevant patients.
What does the Guardant360 Response test measure?
The Guardant360 Response test measures changes in circulating tumor DNA (ctDNA) levels to indicate treatment response.
How does Guardant Health's coverage expansion affect patients?
The coverage expansion makes treatment response monitoring more accessible for patients, allowing oncologists to make better-informed therapeutic decisions.
What other tests have Medicare covered from Guardant Health?
Medicare has previously covered various Guardant tests, including Guardant360, Guardant360 TissueNext, and Guardant Reveal.
