TEST:

Guardant360 TissueNext™

TMB-H tumors had a significant enrichment for alterations in genes encoding proteins involved in the DNA repair pathway and growth factor receptor signal transduction. Combining immune checkpoint inhibitors with targeted therapies aimed at specific pathways could be further explored to potentially enhance outcomes for patients with solid tumors.

For cfDNA: Detection rates of NCCNr and HRRm were similar to those reported for tissue-based NGS in analyzed cancer types. Conclusions Mutations in HRR genes can be successfully analyzed using either tumor tissue or cfDNA NGS.

Conclusions Our analysis revealed that this CGP assay can detect actionable and rare alterations with expected frequency with a median TAT of 13 days. Biomarker detection was feasible even when TC<20%.

Background FDA has now approved pembrolizumab for all unresectable or metastatic TMB-H tumors, tissue based (invasive) Comprehensive Genomic Profiling (CGP) is considered as gold standard for the same...The non-invasive nature with higher sensitivity of ctDNA analysis makes it an attractive alternative to tissue biopsies. In situations where tissue is available, Complementary CGP testing of both, tissue and ctDNA should be encouraged to adequately identify patients for immunotherapy and targeted therapy.

Conclusions ctDNA NGS offered quicker turnaround and found a similar number of CI mutations as tissue NGS therefore a ctDNA NGS first approach could be preferred. However, concurrent use of both the techniques offers broadest coverage of mutation detection.

"In this dataset, concurrent liquid and tissue biopsy identified an on-label alteration in ~1/4 of patients with high concordance. Liquid biopsy demonstrated faster TAT than tissue. These data support the updated guideline language and demonstrate that concurrent testing captures the greatest number of on-label alterations with faster time to results, which is especially important given risk of tissue QNS."

"Guardant Health, Inc...announced 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....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."

"Guardant Health, Inc...and Hikma Pharmaceuticals PLC...announced an agreement to promote Guardant Health’s portfolio of liquid and tissue biopsy tests for cancer screening, recurrence monitoring and tumor mutation profiling across all solid cancers in countries across the Middle East and North Africa (MENA)...The tests offered include Shield™ for cancer screening and early detection, Guardant Reveal™ for minimal residual disease detection and recurrence monitoring, and Guardant360® and Guardant360 TissueNext™ for comprehensive genomic profiling across all solid cancers."

J.P. Morgan 42nd Annual Healthcare Conference Presentation

"Zydus Lifesciences and Guardant Health have agreed to jointly promote the Guardant360 portfolio of liquid and tissue biopsy tests across India and Nepal...The tests to be promoted include the Guardant360 and Guardant360 TissueNext tests for genomic profiling and the Guardant360 Response test for monitoring response to treatment..."

In breast cancer (n=22), relevant alterations included ERBB2 amp (22%) and mutations in PIK3CA (43%), ESR1 (4.8%), ERBB2 (4.8%) and BRCA1/2 (4.8%). Conclusions This analysis of the first tumor samples tested by a new CGP panel in AME demonstrated detection of actionable alterations at the expected frequency with only 15 days median TAT.

"Guardant Health Inc...announced today a strategic collaboration on the development, regulatory approval and commercialization of the Guardant360^® CDx and Guardant360 TissueNext™ assays as companion diagnostics for taletrectinib in the United States and European Union....The collaboration will focus on the use of the Guardant tests for comprehensive genomic profiling to identify patients with the specific tumor mutations that are targeted by taletrectinib."

"Guardant Health, Inc...announced today the introduction of Guardant Galaxy^TM, a suite of advanced analytical technologies developed internally and through outside partnerships to enhance the performance and clinical utility of Guardant Health’s portfolio of cancer tests and to power the next generation of biomarker and drug discovery....The AI-powered scoring algorithm for the enhanced Guardant360 TissueNext PD-L1 test, which is now commercially available, improved detection of the cancer biomarker by more than 20 percent compared to manual pathologist interpretation in the most challenging non-small cell lung cancer (NSCLC) cases....Guardant Health also plans to expand the Guardant Galaxy technology suite over time to include other technology partnerships that will support additional segments of its cancer diagnostics portfolio."

"Codex Genetics...has signed on as the exclusive distributor of Guardant Health's precision oncology tests in Hong Kong and Macau...According to Hong Kong-based Codex, the deal includes the liquid biopsy tests Guardant360 for solid tumor mutation profiling, Guardant Reveal for residual disease and recurrence monitoring in early-stage colorectal cancer patients, and Guardant360 Response for predicting patient responses to immunotherapy and targeted therapy, as well as the tissue-based Guardant TissueNext genomic profiling panel."

"Guardant Health, Inc...and Adicon Holdings Limited...announced a strategic partnership to offer Guardant Health's comprehensive genomic profiling (CGP) tests to biopharmaceutical companies conducting clinical trials in China...As part of the relationship, Guardant Health will license to Adicon its industry-leading liquid biopsy technology, including the Guardant360® and GuardantOMNITM tests, and the Guardant360 TissueNextTM tissue-based biopsy for patients with any solid cancerous tumor."

Pts with untreated ALK+ advanced NSCLC had higher ORRs and potentially longer PFS across predefined biomarker subgroups when treated with lorlatinib compared with crizotinib in the phase 3 CROWN study. Based on pretreatment ctDNA and tumor tissue analyses, lorlatinib led to strong clinical benefit regardless of the type of ALK rearrangement or presence of potential driver co-mutation.

"Guardant Health, Inc...announced that Palmetto GBA, a Medicare administrative contractor for the Molecular Diagnostics Services program (MolDX), has conveyed coverage for Guardant360 TissueNext™ under the existing local coverage determination (LCD) (MolDX: Next-Generation Sequencing for Solid Tumors). Guardant360 TissueNext is the company’s first tissue-based test to help oncologists identify patients with advanced cancer who may benefit from biomarker-informed treatment...The policy covers Guardant360 TissueNext for Medicare fee-for-service patients with advanced solid tumor cancers as a standalone service."