Non-small cell lung cancer stage I

MENLO PARK, Calif. & CAMBRIDGE, England--(BUSINESS WIRE)-- GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, announced today that participants from Japan, via a collaboration with AstraZeneca (LSE/STO/Nasdaq:AZN), will have their samples tested using GRAIL’s novel risk classification test on its Methylation Platform. This assay has been validated for recurrence risk classification in newly diagnosed Stage I lung adenocarcinoma. GRAIL’s Methylation Platform enables tissue-free, blood-based cancer detection that can be customized for a suite of precision applications across hematological and solid tumors, including risk stratification, molecular subtyping, and molecular response. This study with AstraZeneca aims to demonstrate the test’s capability to deliver results within 10 days without the need for tumor tissue, supporting use in future global pharmaceutical clinical trials. “The development of this risk classification test as part of GRAIL’s clinical oncology portfolio is a significant milestone in our ongoing commitment to support patient care with novel, non-invasive tests for early detection and beyond,” said Jeffrey Venstrom, MD, Chief Medical Officer at GRAIL. “GRAIL’s tissue-free, blood-only methodology is designed to aid in clinical trial selection with potential for customizable diagnostic approaches that can enable precision oncology.” In 2022, GRAIL announced a broad strategic collaboration with AstraZeneca to develop and commercialize companion diagnostic (CDx) assays for use with AstraZeneca’s therapies. In December 2023, GRAIL announced the analytical and clinical validation of a novel prognostic test in Stage I lung adenocarcinoma. About GRAIL GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. 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 headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC, is a subsidiary of Illumina, Inc. (NASDAQ:ILMN) currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission. For more information, please visit grail.com. Laboratory/Test Information GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. GRAIL’s current product offerings have not been cleared or approved by the U.S. Food and Drug Administration.

TUESDAY, Jan. 30, 2024 -- There has been an increase in breast cancer incidence rates among young U.S. women from 2000 to 2019, according to a study published online Jan. 26 in JAMA Network Open . Shuai Xu, M.P.H., from Washington University School of Medicine in St. Louis, and colleagues assessed recent trends and how period and cohort effects may affect trends in breast cancer incidence among young U.S. women (aged 20 to 49 years). The analysis included data from 217,815 women with a primary invasive breast cancer identified from the Surveillance, Epidemiology, and End Results registries (2000 to 2019). The researchers found that the majority were diagnosed with an estrogen receptor (ER)-positive/progesterone receptor (PR)-positive tumor (61.5 percent) and were diagnosed with a stage I tumor (37.6 percent). There was an overall increase in incidence of invasive breast cancer (average annual percent changes [AAPC], 0.79), with similar trends seen across almost all racial and ethnic groups. Age-standardized incidence rates (ASIR) increased for ER-positive/PR-positive (AAPC, 2.72) and ER-positive/PR-negative tumors (AAPC, 1.43), but decreased for ER-negative/PR-positive tumors (AAPC, −3.25). ASIR were highest among non-Hispanic Black women (aged 20 to 29 years: incidence rate ratios [IRR], 1.53; aged 30 to 39 years: IRR, 1.15). However, for women aged 40 to 49 years, ASIR was lower for non-Hispanic Black women versus non-Hispanic White women (IRR, 0.96). Both cohort and period effects were seen on breast cancer incidence in an age-period-cohort analysis. "These results suggest that understanding factors driving differential trends in incidence rates for different age groups by race and ER-positive status should provide insights into breast cancer prevention in young women," the authors write. Abstract/Full Text Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions. Posted January 2024 More news resources FDA Medwatch Drug Alerts Daily MedNews News for Health Professionals New Drug Approvals New Drug Applications Drug Shortages Clinical Trial Results Generic Drug Approvals Subscribe to our newsletter Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Validation Results Using a Plasma-based Targeted Methylation Assay Demonstrate Potential to Identify High-Risk Patients who Might Benefit From Additional Treatment MENLO PARK, Calif. & CAMBRIDGE, England & SEOUL, South Korea--(BUSINESS WIRE)-- GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, highlighted the presentation of analytical and clinical validation data on a novel prognostic test in early-stage lung cancer, generated through collaboration with the Samsung Medical Centre and AstraZeneca (LSE/STO/Nasdaq: AZN). The results of the studies demonstrate sensitive and specific detection of circulating tumor DNA (ctDNA) for Lung Adenocarcinoma (LUAD) at a clinically meaningful threshold for disease prognostication. This is a novel tissue-free diagnostic that has the potential to identify high-risk patients prior to surgery and/or treatment. The findings were presented in poster sessions at the North America Conference on Lung Cancer 2023 in Chicago, held Dec. 1-3, 2023. “These results are an important step in establishing oncology capabilities for GRAIL’s Methylation Platform for important cancer-specific applications beyond early cancer detection,” said Jeffrey Venstrom, MD, Chief Medical Officer at GRAIL. “These studies demonstrate that a new tissue-free methylated ctDNA assessment in Stage I lung cancer can potentially identify patients at higher risk for recurrence.” The clinical validation studies analyzed pre-surgical plasma samples from 602 patients with EGFR/ALK wild-type clinical Stage I NSCLC (staging determined by TNMv8). A GRAIL assay was used to measure ctDNA detection with a prespecified threshold in a prospectively defined retrospective study. The presence of ctDNA correlated with an inferior two-year recurrence-free survival (HR 3.8 [95%CI 2.3–6.4], P<0.001 comparing ctDNA+ versus ctDNA-). ctDNA positivity in clinical stage I LUAD was associated with higher rates of mediastinal nodal upstaging at resection, PD-L1 positivity, and grade 3 histology. In addition, analytical studies demonstrate analytical specificity of 96.9% (as determined in healthy donors), 100% accuracy to detect signal at low ctDNA input (2ng) and a robust LoD95 of 44 ppm tumor methylated fraction (TMeF: a measure of ctDNA abundance). In 2022, GRAIL announced a broad strategic collaboration with AstraZeneca to develop and commercialize companion diagnostic (CDx) assays for use with AstraZeneca’s therapies. In January 2023, GRAIL announced the availability of its state-of-the-art research use only (RUO) methylation solution which is being leveraged by pharmaceutical companies for custom oncology applications. About GRAIL GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. 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 headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC, is a subsidiary of Illumina, Inc. (NASDAQ:ILMN) currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission. For more information, please visit grail.com. Laboratory/Test Information GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The RUO test was developed, and its performance characteristics were determined by GRAIL. The RUO test is for research use only, not for diagnostic purposes. GRAIL’s current product offerings have not been cleared or approved by the U.S. Food and Drug Administration.