GRAIL Presents Positive Analytical Validation Data on its Methylation-Based Post-Diagnostic Cancer Research Solution at American Association for Cancer Research (AACR) Annual Meeting 2023

Rhea-AI Summary

GRAIL, LLC presented significant analytical validation data at the AACR Annual Meeting 2023, showcasing its innovative methylation-based solution designed to enhance cancer detection research. The study highlighted the strong analytical sensitivity and specificity of their multi-cancer post-diagnosis solution, which analyzes cfDNA from blood samples. Results indicated a median limit of detection of 0.023% across 12 solid tumor types, with analytical specificity at 98.47% and precision at 94.6%. This breakthrough is part of GRAIL’s ongoing commitment to developing technologies that enable early cancer detection. This solution, now available for biopharmaceutical partners, underscores GRAIL's mission to combat cancer effectively.

Positive

• Achieved a median limit of detection of 0.023% across 12 solid tumor types.
• Demonstrated analytical specificity of 98.47% and precision of 94.6%.

Negative

• None.

Analytical Study Results Show Targeted Methylation-Based Solution Has Strong Analytical Sensitivity, Specificity, Precision and Reliability in Many Solid Tumors

Research Adds to Data Supporting Potential of GRAIL’s Methylation Platform Across the Cancer Care Continuum

MENLO PARK, Calif.--(BUSINESS WIRE)-- GRAIL, 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). 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. 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.

“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. “Current post-diagnostic cancer detection tests often require tumor tissue and are limited by their specificity to a narrow set of cancers. 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. 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.”

The analytical study analyzed cfDNA blood samples from cancer and non-cancer donors. Analytical sensitivity was assessed in 12 different solid tumor types. Results demonstrated a robust median limit of detection (LOD95) of 0.023% based on measures of the abnormally methylated ctDNA fraction. Analytical specificity was 98.47% and overall precision across replicates was 94.6%.

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. Several biopharmaceutical partners leveraged early access to the RUO technology solution.

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, 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.

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For GRAIL

Corporate Communications

Trish Rowland

Cammy Duong

pr@grail.com

Source: GRAIL, LLC

FAQ

What results did GRAIL announce regarding its methylation-based solution on April 19, 2023?

GRAIL announced strong analytical validation data demonstrating a median limit of detection of 0.023% and an analytical specificity of 98.47% for its methylation-based cancer detection solution.

What was presented at the AACR Annual Meeting 2023 concerning GRAIL's new solution?

GRAIL presented data showing the strong sensitivity and specificity of its methylation-based post-diagnosis solution, which can detect multiple cancer types without needing tissue samples.

What does the newly launched methylation-based solution by GRAIL target?

The solution targets early detection of multiple cancer types using cell-free DNA obtained from blood samples, enhancing cancer research capabilities.

How does GRAIL's methylation technology improve cancer detection?

It allows detection of multiple cancers with high sensitivity and specificity, reducing reliance on tumor tissue samples.

What is the significance of the study's findings for cancer research?

The findings represent a key advancement in post-diagnostic cancer research, improving the ability to monitor cancer prognosis and recurrence.