Guardant Health Receives Medicare Coverage for Guardant360 Response to Monitor Cancer Patient Response to Immunotherapy

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.