On April 19, 2023 GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, reported analytical validation data on its recently launched methylation-based post-diagnosis solution to accelerate cancer research (abstract LB297) (Press release, Grail, APR 19, 2023, View Source [SID1234630333]). 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) (Free AACR Whitepaper) Annual Meeting 2023 in Orlando, held April 14-19.
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"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.