Blood exams might be helpful to detect most cancers. However they’ve limitations: they could solely be helpful for a single most cancers or require tumor tissue. The Menlo Park-based firm GRAIL has developed a tissue-free, multi-cancer detection check (“Submit-Analysis Most cancers Analysis Answer”) based mostly on methylation sequencing of cfDNA from blood. The check can at the moment be used to judge cfDNA purposes in most cancers analysis, together with, they are saying, “remedy analysis, recurrence monitoring, and prognostic steering.”
Throughout a late-breaking poster session on the final day of the AACR assembly, the corporate offered analytical validation information on this just lately launched check which leverages the proprietary methylation platform to judge cfDNA remoted from blood. GRAIL had introduced the supply of this analysis use solely (RUO) check for biopharmaceutical firms only a few months in the past—in January.
The examine analyzed cfDNA blood samples from most cancers and non-cancer donors. Analytical sensitivity was assessed in 12 completely different stable tumor varieties. Outcomes demonstrated a median restrict of detection (LOD95) of 0.023% based mostly on measures of the abnormally methylated ctDNA fraction. Analytical specificity was 98.47% and general precision throughout replicates was 94.6%.
“These outcomes are an necessary step in establishing the efficiency of our post-diagnostic methylation-based resolution for most cancers analysis,” mentioned Jeffrey Venstrom, MD, chief medical officer at GRAIL. “Present post-diagnostic most cancers detection exams usually require tumor tissue and are restricted by their specificity to a slender set of cancers. With GRAIL’s methylation expertise, the analytical examine outcomes confirmed that we are able to detect a number of kinds of most cancers with sturdy sensitivity with out the necessity for a tissue pattern. This resolution is a flexible possibility for a spread of analysis makes use of together with most cancers prognosis, identification of minimal residual illness and recurrence monitoring, and biomarker discovery.”
