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TEST:
Guardant360 Response™

Type:
Laboratory Developed Test
Related tests:
5ms
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™
12ms
Guardant Health Receives Medicare Coverage for Guardant360 Response to Monitor Cancer Patient Response to Immunotherapy (Businesswire)
"Guardant Health, Inc...announced today that Palmetto GBA, a Medicare administrative contractor for the Molecular Diagnostics Services program (MolDX), has conveyed coverage for the Guardant360 Response test....Following this decision, the Guardant360 Response test is now covered for fee-for-service Medicare patients in the U.S. with metastatic or inoperable solid tumors who are on an immune checkpoint inhibitor therapy. The coverage includes a Guardant360 CDx or LDT test before initiating therapy to establish a ctDNA baseline and a Guardant360 Response test 4 to 10 weeks after the therapy has been initiated to measure the change in ctDNA level."
Reimbursement
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Guardant360 Response™
1year
Use of circulating tumor DNA (ctDNA) for early assessment of treatment response in patients with non-small cell lung cancer (NSCLC): A real-world (RW) analysis incorporating baseline ctDNA level and molecular response (AACR 2023)
These data demonstrate a statistically significant interaction between baseline ctDNA level and treatment-induced ctDNA level change in association with RW clinical outcomes. This facilitates the development of patient-based models incorporating baseline ctDNA level with ctDNA molecular response for association with RW clinical outcomes.
Real-world evidence • Clinical • IO biomarker • Circulating tumor DNA • Real-world
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Guardant360® CDx • Guardant360 Response™
1year
Guardant360 Response™: CMS reimbursement in 2023 (Guardant Health)
J.P. Morgan 41st Annual Healthcare Conference Presentation
Reimbursement
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Guardant360 Response™
over1year
Use of circulating tumor DNA (ctDNA) for early assessment of treatment response in patients with advanced colorectal cancer (aCRC): A real-world (RW) analysis. (ASCO-GI 2023)
Patients with aCRC classified as molecular responders, as calculated by this algorithm, had prolonged time on treatment and overall survival. Compared to tumor markers, ctDNA has a short half-life, which can allow for early response assessment, as shown by our study. These findings are relevant for clinical care, with future potential to allow for adaptive clinical trial design.
Real-world evidence • Clinical • Circulating tumor DNA • Real-world • Metastases
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Guardant360® CDx • Guardant360 Response™
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
over1year
ctDNA molecular response based on breast cancer driver mutations predicts progression in aromatase inhibitor-sensitive first line treatment of oestrogen receptor-positive (ER+) HER2-negative (HER2-) advanced breast cancer. (SABCS 2022)
PADA-1 was designed to assess the clinical utility of sequential analysis of ctDNA for emerging ESR1 mutations to trigger an early switch from AI plus palbociclib to fulvestrant plus palbociclib treatment. Changes in ctDNA fraction during the first weeks of treatment are predictive of long term clinical benefit on an individual patient basis, particularly during the first year of therapy. Adjusting the MR threshold and/or limiting to genes known to be relevant in the specific tumor can tailor the assessment of ctDNA change to specific clinical scenarios where greater sensitivity or specificity may be required. The identification of patients at high risk for early clinical failure at the onset of treatment may allow for therapy escalation and/or change to improve outcome in this population.
Clinical • Tumor mutational burden • BRCA Biomarker • Circulating tumor DNA
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • RB1 (RB Transcriptional Corepressor 1) • AKT1 (V-akt murine thymoma viral oncogene homolog 1) • PALB2 (Partner and localizer of BRCA2) • GATA3 (GATA binding protein 3)
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TP53 mutation • ER positive • BRCA1 mutation • HER-2 negative • PIK3CA mutation • PALB2 mutation • ER mutation • ESR1 mutation • ER positive + HER-2 negative
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Guardant360® CDx • Guardant360 Response™
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Ibrance (palbociclib) • fulvestrant
over1year
Use of real-world (RW) data to assess the ability of circulating cell-free tumor DNA (ctDNA) molecular response to assess therapeutic outcomes in patients with non-small cell lung cancer (NSCLC) (SITC 2022)
Ethics Approval This research was approved by the Quorum Institutional Review Board (IRB) for the generation of de-identified datasets for research purposes. View this table: View inline View popup Download powerpoint Abstract 6 Table 1
Real-world evidence • Clinical • IO biomarker • Circulating tumor DNA
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EGFR (Epidermal growth factor receptor)
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Guardant360® CDx • Guardant360 Response™
almost2years
Guardant Health to present new data from its broad portfolio of blood tests at 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Guardant Health Press Release)
"Guardant Health, Inc...announced today it will present new data at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting from June 3-7 in Chicago. Among the 19 abstracts are oral presentations highlighting the use of real-world data to identify resistance to early treatment in advanced breast cancer and the use of enhanced biomarker analysis to evaluate progression-free survival data in metastatic breast cancer therapy."
Real-world evidence • Clinical data
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Guardant360® CDx • GuardantOMNI • Guardant360 Response™ • GUARDANT SHIELD • GuardantREVEAL
almost2years
Guardant Health announces partnership with Epic to streamline access to company’s broad portfolio of cancer tests (Guardant Health Press Release)
"Guardant Health, Inc...announced a partnership with Epic...to integrate the company’s broad portfolio of cancer tests with Epic. This integration will make it easier for health systems, community healthcare providers and retail health clinics to make Guardant Health blood tests part of routine clinical care by providing direct ordering access and results delivery...In addition to Guardant SHIELD, clinicians will be able to order current flagship tests such as Guardant360® CDx and Guardant360 Response™ to help physicians inform treatment decisions for patients with advanced cancer, and Guardant Reveal™ to detect residual and recurrent disease in patients with early-stage cancer."
Licensing / partnership
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Guardant360® CDx • Guardant360 Response™ • GUARDANT SHIELD • GuardantREVEAL
2years
Predictive ability of circulating tumor DNA by Guardant360 in poziotinib-treated patients with NSCLC harboring HER2 exon 20 insertion mutations (AACR 2022)
Baseline plasma ctDNA genotyping correlated with tumor tissue based NGS in an NSCLC patient population with HER2 mutations. Poziotinib treatment resulted in mVAF reduction, which correlated with clinical response per RECIST1.1. Assessment of longitudinal changes in ctDNA during drug therapy may potentially be used to predict patient response and possibly tumor resistance.
Clinical • Circulating tumor DNA
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 mutation • HER-2 exon 20 insertion • HER-2 exon 20 mutation • HER-2 A775 • HER-2 exon 23 mutation
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Guardant360® CDx • Guardant360 Response™
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Pozenveo (poziotinib)