On June 4, 2024 Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, reported the launch of a new version of its Guardant360 TissueNext test that expands the number of genes it identifies in a tumor tissue sample to 498 (Press release, Guardant Health, JUN 4, 2024, View Source [SID1234644109])c. These genes, or cancer biomarkers, enable oncologists to identify the targeted therapies or treatment strategies that are most effective for patients with advanced cancer. In addition to the panel expansion, Guardant has improved the test’s operational workflow for a faster turnaround time.
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The new Guardant360 TissueNext test will be covered for Medicare fee-for-service patients with advanced solid tumor cancers as a standalone service, based on coverage conveyed by Palmetto GBA, a Medicare administrative contractor for the Molecular Diagnostics Services program (MolDX), under the existing local coverage determination.
"The launch of the new Guardant360 TissueNext test is another step forward in our mission to conquer cancer with data," said Helmy Eltouky, Guardant Health chairman and co-CEO. "In addition to identifying guideline-recommended biomarkers, the upgraded test now provides more comprehensive gene coverage, so oncologists can make better informed decisions about the optimal treatment strategy for their patients with advanced cancer and help improve their outcomes."
Guardant360 TissueNext identifies clinically relevant actionable biomarkers in tumor tissue to help oncologists select patients with advanced cancer who may benefit from biomarker-informed treatment. Results are provided in less than two weeks.
The test, which first received Medicare coverage in March 2022, is part of Guardant’s comprehensive portfolio of blood- and tissue-based genomic profiling tests, including Guardant360 CDx, the first liquid biopsy test approved by the FDA for comprehensive genomic profiling of all solid tumors. The Guardant360 TissueNext test can be ordered alone or in combination with Guardant360 CDx to support guideline-recommended complementary liquid and tissue genomic profiling testing for advanced breast and lung cancer.