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TEST:
Guardant360 TissueNext™

Type:
Laboratory Developed Test
Related tests:
12d
Guardant Health introduces new Guardant360 TissueNext test with nearly 500 biomarkers to identify more treatment options for patients with advanced cancer (Businesswire)
"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."
Launch
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Guardant360 TissueNext™
5ms
Guardant Health and Hikma partner to offer cancer screening and comprehensive genomic profiling tests in the Middle East and North Africa (Guardant Health Press Release)
"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."
Licensing / partnership
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Guardant360® CDx • Guardant360 TissueNext™ • GUARDANT SHIELD • GuardantREVEAL
5ms
Guardant360 TissueNext™: Launching upgraded version in 2024 (Guardant Health)
J.P. Morgan 42nd Annual Healthcare Conference Presentation
Launch
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Guardant360 TissueNext™
8ms
Zydus Lifesciences to co-promote Guardant Health biopsy tests in India and Nepal (The Hindu Business Line)
"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..."
Licensing / partnership
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Guardant360® CDx • Guardant360 TissueNext™ • Guardant360 Response™
8ms
Real-world performance of a comprehensive next-generation sequencing (NGS) panel for patients (pts) with solid tumors from Asia and the Middle East (AME) (ESMO Asia 2023)
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.
Real-world evidence • Clinical • Tumor mutational burden • MSi-H Biomarker • BRCA Biomarker • Next-generation sequencing • Real-world
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EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ER (Estrogen receptor) • ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • MET (MET proto-oncogene, receptor tyrosine kinase) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • FGFR1 (Fibroblast growth factor receptor 1) • CCNE1 (Cyclin E1)
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BRAF V600E • KRAS mutation • BRCA2 mutation • BRCA1 mutation • EGFR mutation • MSI-H/dMMR • KRAS G12C • PIK3CA mutation • BRAF V600 • NTRK1 fusion • HER-2 mutation • MET exon 14 mutation • ALK fusion • KRAS G12 • EGFR mutation + PIK3CA mutation
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Guardant360 TissueNext™
over1year
Guardant Health and AnHeart Therapeutics Announce Collaboration to Develop Guardant360 CDx and Guardant360 TissueNext as Companion Diagnostics for Taletrectinib in Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer (Businesswire)
"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."
Licensing / partnership
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Guardant360® CDx • Guardant360 TissueNext™
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taletrectinib (AB-106)
over1year
Guardant Health introduces Guardant Galaxy suite of advanced AI analytics to enhance its portfolio of cancer tests and accelerate biomarker discovery (Businesswire)
"Guardant Health, Inc...announced today the introduction of Guardant GalaxyTM, 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."
Clinical
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Guardant360 TissueNext™
over1year
Codex Genetics inks distribution deal for Guardant Health cancer tests in Asia (Genomeweb)
"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."
Licensing / partnership
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Guardant360® CDx • Guardant360 TissueNext™ • Guardant360 Response™ • GuardantREVEAL
almost2years
Guardant Health and Adicon announce strategic partnership to offer comprehensive genomic profiling tests to accelerate development of new cancer therapies in China (PRNewswire)
"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."
Licensing / partnership
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Guardant360® CDx • GuardantOMNI • Guardant360 TissueNext™
2years
Phase 3 trial of lorlatinib in treatment-naive patients (Pts) with ALK-positive advanced non–small cell lung cancer (NSCLC): Comprehensive plasma and tumor genomic analyses. (ASCO 2022)
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.
P3 data • Clinical • Tumor mutational burden
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KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • EML4 (EMAP Like 4)
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TP53 mutation • KRAS mutation • ALK positive • ALK rearrangement • KRAS G12V • ALK fusion • KRAS G12
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Guardant360® CDx • Guardant360 TissueNext™
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Xalkori (crizotinib) • Lorbrena (lorlatinib)
over2years
Guardant Health receives Medicare coverage for Guardant360 TissueNext™ Test (Guardant Health Press Release)
"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."
Reimbursement
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Guardant360 TissueNext™