The GRAIL approach
GRAIL is poised to detect cancer early by combining high-intensity sequencing of unprecedented breadth and depth with the techniques of modern data science. Through what we believe to be one of the largest clinical study programs ever pursued in genomic medicine, GRAIL is creating vast datasets to develop evidence supporting our products.
Seeking cancer signals in the blood
An increasing body of evidence suggests tumors release cell-free nucleic acids (cfNAs) into the bloodstream. cfNAs are small fragments of DNA and RNA, and reflect the genomic features of the tumor from which they originated. cfNAs are thought to be a direct measure of cancer and can be detectable in the bloodstream of people with cancer, potentially even before symptoms present.
Our understanding of cancer has been greatly enhanced through Initiatives elucidating the genomic and molecular biology of tumors. The Cancer Genome Atlas (TCGA)1 project, for example, has established that cancers are extremely heterogeneous.
The complexity of tumors suggests that measurements that capture the breadth of the heterogeneous cancer genome represent the most comprehensive and direct signature of disease biology. GRAIL’s unique ability to sequence broadly across the genome allows us to discover the millions of unique patterns that define cancer.
Because cfNAs are a more direct measure of cancer, and represent the genomic diversity of cancer throughout the body, cfNA-based tests have the potential to be highly specific and sensitive for early cancer detection.
The fraction of tumor-derived cfNA in the bloodstream compared to cfNA from non-cancerous cells is very small, necessitating the ability to distinguish faint signals of early tumors from an overwhelming background of genomic material.
GRAIL is using the latest data science tools to query cfNAs at extraordinary depth and detect cancer signals.
We feed our large clinical and sequencing data sets into our bioinformatics and machine learning algorithms to distinguish the true invasive cancer signals from a sea of background biological noise.
Our commitment to scientific rigor
GRAIL is committed to developing a deep understanding of cancer biology. We are building an atlas characterizing the landscape of cell-free nucleic acids in thousands of individuals with and without cancer, and will validate our early detection products in real-world populations.
We are generating scientific and clinical evidence through clinical studies enrolling tens of thousands of participants and in some of the largest cancer-related studies to date.