Guardant Health, Inc. (NASDAQ: GH), a prominent figure in precision oncology, has unveiled an upgraded version of its Guardant360 TissueNext test, significantly broadening its gene identification capabilities within tumor tissue samples to encompass 498 genes. These genes, serving as cancer biomarkers, empower oncologists to pinpoint targeted therapies or treatment approaches most suitable for patients grappling with advanced cancer. Alongside panel expansion, Guardant has streamlined the operational workflow of the test, promising a swifter turnaround time.
This enhanced Guardant360 TissueNext test will now extend coverage to Medicare fee-for-service patients diagnosed with advanced solid tumor cancers as an independent service, aligning with the coverage guidelines stipulated by Palmetto GBA, a Medicare administrative contractor for the Molecular Diagnostics Services program (MolDX®).
Guardant Health’s Chairman and co-CEO, Helmy Eltouky, emphasized the significance of this launch in advancing their mission to combat cancer using data-driven strategies. With an increased scope of gene coverage, the upgraded test aims to furnish oncologists with more comprehensive insights, facilitating better-informed decisions regarding optimal treatment strategies for patients facing advanced cancer, thereby potentially enhancing treatment outcomes.
Guardant360 TissueNext operates by identifying clinically relevant actionable biomarkers in tumor tissue, aiding oncologists in identifying individuals with advanced cancer who may benefit from treatment guided by biomarker analysis. Results are typically delivered in less than two weeks.
Originally gaining Medicare coverage in March 2022, Guardant360 TissueNext forms a pivotal component of Guardant’s comprehensive range of genomic profiling tests, encompassing both blood- and tissue-based analyses. It complements Guardant360 CDx, the FDA-approved liquid biopsy test for comprehensive genomic profiling of solid tumors. This tissue-based test can be ordered independently or in conjunction with Guardant360 CDx to support guideline-endorsed liquid and tissue genomic profiling testing for advanced breast and lung cancer.