GRAIL Announces Novel Risk Classification Test to Be Used in Lung Cancer Study
GRAIL, in collaboration with AstraZeneca, will test samples from Japanese participants using its risk classification test on the Methylation Platform for lung adenocarcinoma. The study aims to show results within 10 days without tumor tissue, supporting future pharmaceutical trials.
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Collaboration with AstraZeneca to test samples from Japan using GRAIL's risk classification test on the Methylation Platform for lung adenocarcinoma.
Test aims to deliver results within 10 days without the need for tumor tissue, supporting future global pharmaceutical clinical trials.
GRAIL's tissue-free, blood-based cancer detection method can be customized for various precision applications in hematological and solid tumors.
The integration of GRAIL's Methylation Platform in risk classification for lung adenocarcinoma represents an advancement in precision oncology. The ability to perform blood-based cancer detection without the need for tissue samples simplifies the diagnostic process and minimizes invasiveness, which is a significant benefit for patients. From a clinical perspective, this could lead to earlier intervention and personalized treatment strategies, improving outcomes for individuals with Stage I lung adenocarcinoma—a cancer type known for its complexity and variability in prognosis.
Moreover, the potential application of this technology in clinical trials is notable. It could refine patient selection criteria, enabling more targeted and efficient studies. The implication here is a faster, more streamlined path to bringing effective cancer therapies to market, which could be particularly beneficial for AstraZeneca's pipeline of treatments. However, it is essential to monitor the long-term accuracy and cost-effectiveness of this assay in broader populations beyond the initial Japanese cohort.
The announcement by GRAIL is a noteworthy development in the field of companion diagnostics. The collaboration with AstraZeneca underscores the industry's trend towards personalized medicine, where treatments are tailored to the genetic profile of a patient's tumor. The ten-day turnaround time for test results is impressive, potentially accelerating the pace at which patients can begin treatment. This speed is a competitive advantage in the healthcare industry, where timely interventions can be the difference between life and death.
From a research and development standpoint, the validation of GRAIL's assay is a key step in proving the utility of methylation-based tests. Methylation patterns are an emerging biomarker in oncology and their successful application could pave the way for more non-invasive tests across various cancer types. It is prudent to consider the scalability of this technology and how it might impact the broader market for cancer diagnostics, including any challenges in adoption by healthcare providers.
The strategic collaboration between GRAIL and AstraZeneca is indicative of the growing market for companion diagnostics within the pharmaceutical industry. As drug developers seek to enhance the efficacy of their therapies through precision medicine, the demand for diagnostic tests that can accurately stratify patients based on risk is likely to increase. This partnership could position both companies favorably in a market that is becoming increasingly competitive.
Investors and stakeholders should note the potential for this technology to create new revenue streams for GRAIL and AstraZeneca, particularly if the test is adopted in clinical trials and eventually in routine clinical practice. The early detection market is expanding and GRAIL's Methylation Platform could capture a significant share if it proves to be superior to current standards. However, the cost of the test and reimbursement by insurance companies will be important factors affecting its adoption rate and market penetration.
03/18/2024 - 09:00 AM
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.
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For GRAIL
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Source: GRAIL, LLC
What is GRAIL collaborating with AstraZeneca on?
GRAIL is collaborating with AstraZeneca to test samples from Japan using its risk classification test on the Methylation Platform for lung adenocarcinoma.
What is the aim of the study with AstraZeneca?
The study 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.
What is GRAIL's cancer detection method based on?
GRAIL's cancer detection method is tissue-free and blood-based, allowing customization for precision applications in hematological and solid tumors.
When was the collaboration between GRAIL and AstraZeneca announced?
The collaboration between GRAIL and AstraZeneca was announced in 2022.
What did GRAIL announce in December 2023?
In December 2023, GRAIL announced the analytical and clinical validation of a novel prognostic test in Stage I lung adenocarcinoma.
