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TEST:
GuardantINFINITY™

Type:
Laboratory Developed Test
Related tests:
Evidence

News

2ms
Guardant Health to Present Data Highlighting Application of Epigenomics to Advance Precision Oncology at 2024 AACR Annual Meeting (Businesswire)
"Guardant Health, Inc...announced it will present data from nine studies highlighting advances in methylation-based epigenomic analysis for precision oncology at the 2024 American Association for Cancer Research (AACR) Annual Meeting, April 5-10 in San Diego. Multiple poster sessions will report on the utility of using the Guardant Infinity platform across the continuum of cancer care, ranging from predictive histologic subtyping of tumors to cardiac adverse event prediction. Data will also be presented demonstrating strong performance of Guardant Reveal for minimal residual disease (MRD) detection in breast cancer, allowing quantification of ctDNA even in early-stage disease without the need for a tissue specimen."
Clinical data • Clinical
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Guardant360® CDx • GuardantOMNI • GuardantINFINITY™ • GuardantREVEAL
3ms
Tumor-agnostic ctDNA monitoring in patients with metastatic HR+/HER2- breast cancer receiving first-line CDK4/6 inhibitor and endocrine therapy (AACR 2024)
CDK4/6i received included 42/57 (73%) palbociclib, 14/57 (25%) ribociclib and 1/57 (2%) abemaciclib; 40/57 (70%) were in combination with an aromatase inhibitor and 17/57 (30%) with fulvestrant. Baseline methylation TF and ctDNA clearance as measured by GuardantINFINITY were prognostic in this cohort. Longitudinal sampling permitted genomic characterization and detection of alterations conferring acquired-resistance prior to clinical progression. Clinical correlates of ctDNA detection, clearance, and further serial genomic analyses will be presented.
Clinical • Pan tumor • Circulating tumor DNA • Metastases
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HER-2 (Human epidermal growth factor receptor 2) • RB1 (RB Transcriptional Corepressor 1)
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HER-2 negative
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GuardantINFINITY™
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Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant
10ms
Genomic alterations in circulating tumor DNA (ctDNA) and response to ABBV-400 treatment in patients with advanced solid tumors (ESMO 2023)
The antibody-drug conjugate ABBV-400 comprises the c-Met–targeting antibody telisotuzumab conjugated to a potent topoisomerase 1 inhibitor payload. A molecular response was observed in 48% (14/29) of all evaluated pts and 47% (8/17) of pts with CRC; median change from baseline tumor size was -22.5% and -20.3%, respectively. Table: 163P Pts with molecular response and correlation between baseline biomarker status and radiographic response Conclusions ABBV-400 showed promising preliminary efficacy, with molecular and radiographic responses in pts with advanced solid tumors with heterogeneous genomic profiles, including in pts with high TMB and KRAS mutations.
Clinical • Tumor mutational burden • Circulating tumor DNA • Metastases
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KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • MET (MET proto-oncogene, receptor tyrosine kinase) • MSI (Microsatellite instability) • LRP1B (LDL Receptor Related Protein 1B) • PTPRT (Protein tyrosine phosphatase receptor type T)
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KRAS mutation • TMB-H • MET overexpression • PTPRT mutation
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GuardantINFINITY™
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telisotuzumab adizutecan (ABBV-400) • telisotuzumab (h224G11)
12ms
Guardant Health to present 17 scientific abstracts highlighting contribution of its blood tests and real-world data to advances in precision oncology and cancer screening at 2023 ASCO annual meeting (Businesswire)
"Guardant Health, Inc...announced today that the company and its research collaborators will present data from 17 studies that highlight the contribution of Guardant blood tests and real-world data to advances in precision oncology and cancer screening at the 2023 American Society for Clinical Oncology (ASCO) Annual Meeting, June 2-6 in Chicago....Guardant Health will present a session highlighting the performance of the Guardant Infinity platform in the detection of homologous recombination deficiency (HRD) status in patients with breast cancer....Guardant Health collaborators will present a session on the ESR1 mutational landscape and the impact of co-existing resistance variants on clinical outcomes in patients with metastatic breast cancer."
Clinical data
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Guardant360® CDx • GUARDANT SHIELD • GuardantINFINITY™
1year
Detection of homologous recombination deficiency (HRD) using a novel genomic and epigenomic liquid biopsy assay in patients with breast cancer. (ASCO 2023)
In this analysis, we demonstrate that a probabilistic model of genomic and methylation predictors can detect HRD status in patients with breast cancer from cfDNA using GuardantINFINITY. Additional analytical and clinical studies to further evaluate this model are ongoing. With HRD prediction, GuardantINFINITY provides a comprehensive minimally-invasive solution for PARPi and DNA damage treatment selection, longitudinal monitoring, and an exploratory platform for investigating epigenetic signals that may underpin resistance.
Clinical • PARP Biomarker • BRCA Biomarker • Liquid biopsy • Biopsy
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BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • PALB2 (Partner and localizer of BRCA2) • RAD51D (RAD51 paralog D)
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HRD
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GuardantOMNI • GuardantINFINITY™
1year
Guardant Health and Parker Institute for Cancer Immunotherapy (PICI) launch research collaboration to study connection between cancer biomarkers and immunotherapy treatment response (Businesswire)
"Guardant Health, Inc...and the Parker Institute for Cancer Immunotherapy...announced a research collaboration agreement to study the correlation between molecular cancer biomarkers and patient response to immunotherapy treatment across more than 14 different types of cancer. Under the agreement, Guardant Health will analyze patient blood samples from PICI’s RADIOHEAD (Resistance Drivers for Immuno-Oncology Patients Interrogated by Harmonized Molecular Datasets) prospective study of 1,200 individuals on standard-of-care immune checkpoint inhibitor (ICI) treatment regimens in community hospitals....Guardant Health and PICI intend to begin publishing data generated by the study later in 2023."
Licensing / partnership • Clinical data
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GuardantINFINITY™
1year
Guardant Health to Present Data From 14 Studies Highlighting Advances in Precision Oncology and Cancer Screening at 2023 AACR Annual Meeting (Businesswire)
"Guardant Health, Inc...announced today that it will present data from 14 studies highlighting advances in precision oncology and cancer screening at the 2023 American Association for Cancer Research (AACR) Annual Meeting, April 14-19 in Orlando, Florida....In particular, studies show that: Methylome sequencing with a liquid-only approach using the GuardantINFINITY platform can quantify circulating tumor DNA level and change with greater sensitivity and precision than genomic sequencing, making longitudinal ctDNA monitoring accessible to a broader range of patients....The analytical validation of the GuardantINFINITY genomic and epigenomic liquid biopsy platform showed its potential for ultra-sensitive ctDNA detection for minimal residual disease and recurrence surveillance, tumor fraction quantitation for therapy monitoring, oncogenic virus detection, immunogenotyping, epigenotyping, and tumor phenotype characterization, representing a new standard in biomarker discovery."
Clinical data
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Guardant360® CDx • GUARDANT SHIELD • GuardantINFINITY™
1year
Analytical validation of a robust integrated genomic and epigenomic liquid biopsy for biomarker discovery, therapy selection, and response monitoring (AACR 2023)
GuardantINFINITY is a patient-care-ready liquid biopsy capable of integrated genomic and epigenomic analysis of all solid tumors at single-molecule sensitivity. In addition to traditional genotyping compatible with Guardant360 for more content, the technology’s demonstrated LoD showed the potential for ultra-sensitive ctDNA detection for MRD and recurrence surveillance, tumor fraction quantitation for therapy monitoring, oncogenic virus detection, immunogenotyping, epigenotyping, and tumor phenotype characterization, representing a new standard in biomarker discovery.
MSi-H Biomarker • Liquid biopsy • Biopsy
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MSI (Microsatellite instability)
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MSI-H/dMMR
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Guardant360® CDx • GuardantINFINITY™
1year
BRCA1 promoter methylation in sporadic breast cancer patients detected by liquid biopsy (AACR 2023)
GuardantINFINITY, a plasma-based diagnostic assay, detected both BRCA1 PM and genomic alterations in this unspecified advanced breast cancer cohort. The BRCA1 PMdetection rates of 4.0-8.9% are consistent with values previously reported in the literature. As BRCA1 PM has important prognostic and therapeutic implications for the management of breast (as well as ovarian) cancers, additional studies are warranted to further describe the PM patterns across breast cancer subtypes and how these patterns both influence and are influenced by disease evolution and therapeutic response.
Clinical • BRCA Biomarker • Liquid biopsy • Biopsy
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BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • CHEK2 (Checkpoint kinase 2)
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BRCA2 mutation • BRCA1 mutation • ATM mutation
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GuardantINFINITY™
1year
A method for quantifying circulating tumor DNA level and molecular response using methylome sequencing (AACR 2023)
Methylome sequencing using GuardantINFINITY enables accurate and precise quantification of ctDNA level and change with a liquid-only approach, offering longitudinal ctDNA monitoring for more patients than previous methods.
Circulating tumor DNA
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GuardantINFINITY™
1year
Using Kmerizer, a germline and somatic genotyper for immune associated complex alleles in GuardantINFINITY, for immunotherapy response prediction using cfDNA (AACR 2023)
The integration of Kmerizer into GuardantINFINITY enables accurate HLA germline and somatic detection along with neoantigen prediction, offering an enhanced and comprehensive biomarker profiling for ICI outcome prediction.
Tumor mutational burden • IO biomarker
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GuardantINFINITY™
over1year
Guardant Health introduces GuardantINFINITY™ smart liquid biopsy for research use to help bring new cancer therapies to patients sooner (Guardant Health Press Release)
"Guardant Health, Inc...announced...the introduction of GuardantINFINITY™, a next-generation liquid biopsy that provides new, multi-dimensional insights into the complexities of tumor molecular profiles and immune response to advance cancer research and therapy development."
Clinical
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GuardantINFINITY™