REDWOOD CITY, Calif., and MUNICH, Oct. 19, 2018 /PRNewswire/ -- New data demonstrating the high sensitivity and specificity of the blood-based Guardant360® and GuardantOMNI™ assays, developed by Guardant Health (Nasdaq:GH), for reporting biomarkers relevant to immunotherapy treatment selection and drug development will be presented at the European Society of Medical Oncology Annual Meeting. The data come from internal validation studies for reporting tumor mutational burden (TMB) with GuardantOMNI and microsatellite instability (MSI) with Guardant360. Guardant Health recently began reporting MSI-High status for Guardant360 samples.1
In a poster to be presented at ESMO, Guardant Health researchers demonstrated 95% analytical sensitivity for MSI-High status at variant levels below 0.4%, and a lower limit of detection of 0.1% using Guardant360. Furthermore, clinical accuracy data for MSI-High status for samples above the limit of detection was presented from 277 advanced cancer patients samples with known MSI status using tumor tissue. The clinical data demonstrated 98.9% (261/264) specificity and 92.3% sensitivity (12/13) relative to standard tissue IHC, PCR or NGS-based MSI.
"Taken together, these data show the feasibility of reporting immunotherapy-related biomarkers, such as MSI-High, from circulating tumor DNA collected through a simple blood draw," said AmirAli Talasaz, Guardant Health's Co-founder and President. "In order to meaningfully improve patient outcomes using liquid biopsies, we believe that high clinical sensitivity and specificity of detecting such biomarkers should be achieved, especially at the low levels of tumor variants typically found in circulation."
Since its introduction in 2014, the Guardant360 assay has been ordered more than 70,000 times to help inform which therapy may be effective for advanced stage cancer patients with solid tumors. It has been reviewed by more than 80 peer-reviewed publications, which address its analytical validity, clinical validity, and clinical utility in multiple tumor types. For advanced NSCLC, Guardant360 is covered by Medicare and by several private payers, including Cigna and several Blue Cross Blue Shield plans.
The Guardant360 and GuardantOMNI assays are featured in 13 other presentations at ESMO, including two oral presentations and two poster discussion.
Oral Abstract Presentations
Friday, Oct. 19, 16:00, LBA50, Mechanisms of acquired resistance to first-line osimertinib: preliminary data from the phase III FLAURA study
Friday, Oct. 19, 16:12, LBA51, Analysis of resistance mechanisms to osimertinib in patients with EGFR T790M advanced NSCLC from the AURA3 study
Poster Discussion Sessions
Friday, Oct. 19, 14:00, 1380PD, Efficacy of lorlatinib in patients (pts) with ROS1-positive advanced non-small cell lung cancer (NSCLC) and ROS1 kinase domain mutations
Monday, Oct. 22, 15:10, 1895PD, Homology-directed repair (HDR)-defective lung adenocarcinomas (LUACs) in circulating tumor DNA (ctDNA)
Saturday, Oct. 20, 12:30, 97P, Multimodal detection of homologous recombination repair gene mutations (HRRm) in a phase II trial of olaparib plus abiraterone in metastatic castrate resistant prostate cancer (mCRPC)
Saturday, Oct. 20, 12:30, 105P, Detection and clearance of RET variants in plasma cell free DNA (cfDNA) from patients (pts) treated with LOXO-292
Saturday, Oct. 20, 12:30, 131P, Development and analytical validation of a plasma-based tumor mutational burden (TMB) score from next-generation sequencing panels
Saturday, Oct. 20, 12:30, 152P, Circulating tumour DNA experience in patients with cancer of unknown primary
Saturday, Oct. 20, 12:30, 1190P, Microsatellite instability detection by targeted sequencing of cell-free DNA
Saturday, Oct. 20, 12:30, 1346P, Real world cfDNA collection in EGFR-mutant NSCLC
Saturday, Oct. 20, 12:30, 1430P, Cell-free circulating tumour DNA (ctDNA) in the management of patients with non-biopsiable advanced non-small cell lung cancer (NSCLC)
Sunday, Oct. 21, 12:45, 482P, RET rearrangements may arise following anti-EGFR therapy in advanced colorectal cancer,
Sunday, Oct. 21, 12:45, 544P, ctDNA assays identify alterations in RAS, EGFR, and cMET that are unique to RAS-WT patients progressing on anti-EGFR therapy
Sunday, Oct. 21, 12:45, 662P, Biomarker-guided enrichment of the antitumor activity of margetuximab (M) plus pembrolizumab (P) in patients with advanced HER2+ gastric adenocarcinoma (GEA)
Monday, Oct. 22, 15:10, 844P, The clinical impact of targeted next generation sequencing (tNGS) in the treatment of metastatic prostate cancer
About Guardant Health
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs. In pursuit of its goal to manage cancer across all stages of the disease, Guardant Health has launched multiple liquid biopsy-based tests, Guardant360 and GuardantOMNI, for advanced stage cancer patients, which fuel its LUNAR development programs for recurrence and early detection. Since its launch in 2014, Guardant360 has been used by more than 5,000 oncologists, over 40 biopharmaceutical companies and all 27 of the National Comprehensive Cancer Network centers.
1. MSI-H status reporting is not available to customers New York state.
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