GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. under the terms of the Interim Measures Order of the European Commission. (NASDAQ:ILMN) currently held separate from Illumina Inc. GRAIL, LLC, is a subsidiary of Illumina, Inc. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. Several biopharmaceutical partners leveraged early access to the RUO technology solution. GRAIL announced the availability of its state-of-the-art research use only (RUO) targeted methylation-based solution offering for biopharmaceutical companies in January 2023. Analytical specificity was 98.47% and overall precision across replicates was 94.6%. Results demonstrated a robust median limit of detection (LOD95) of 0.023% based on measures of the abnormally methylated ctDNA fraction. Analytical sensitivity was assessed in 12 different solid tumor types. The analytical study analyzed cfDNA blood samples from cancer and non-cancer donors. This solution is a versatile option for a range of research uses including cancer prognosis, identification of minimal residual disease and recurrence monitoring, and biomarker discovery.” With GRAIL’s methylation technology, the analytical study results showed that we can detect multiple types of cancer with strong sensitivity without the need for a tissue sample. “Current post-diagnostic cancer detection tests often require tumor tissue and are limited by their specificity to a narrow set of cancers. “These results are an important step in establishing the performance of our post-diagnostic methylation-based solution for cancer research,” said Jeffrey Venstrom, MD, Chief Medical Officer at GRAIL. The findings were presented in a late-breaking poster session at the American Association for Cancer Research (AACR) Annual Meeting 2023 in Orlando, held April 14-19. Results of the analytical study demonstrated strong analytical sensitivity, specificity and precision of the tissue-free multi-cancer post-diagnosis research solution, which leverages GRAIL’s proprietary methylation platform to evaluate cell-free DNA (cfDNA) isolated from blood. MENLO PARK, Calif., ApGRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, today presented analytical validation data on its recently launched methylation-based post-diagnosis solution to accelerate cancer research (abstract LB297). Research Adds to Data Supporting Potential of GRAIL’s Methylation Platform Across the Cancer Care Continuum Analytical Study Results Show Targeted Methylation-Based Solution Has Strong Analytical Sensitivity, Specificity, Precision and Reliability in Many Solid Tumors
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