GRAIL Announces Significant Progress with Multi-Cancer Early Detection Test Including FDA Breakthrough Device Designation

Liquid biopsy company GRAIL announced today that its multi-cancer test has been granted Breakthrough Device designation from the U.S. Food and Drug Administration. This investigational blood test is in development for the early detection of multiple cancer types in individuals aged 50 and over.

The FDA grants Breakthrough designation to devices that have the potential to provide for more effective diagnosis of life-threatening diseases such as cancer.

“We’re excited the FDA recognizes the potential of our multi-cancer early detection blood test,” said GRAIL CEO Jennifer Cook. “There are no effective early detection tests for the majority of cancer types, and many deadly cancers are often detected too late. We hope our test may offer a chance to address these challenges.”

“We have made significant progress developing our multi-cancer test and look forward to sharing new data at ASCO and other medical conferences this year,” Cook added.

GRAIL previously reported data from the first pre-planned sub-study of its Circulating Cell-free Genome Atlas (CCGA) study, which showed that its three prototype next-generation sequencing (NGS) blood tests were able to detect multiple cancer types from a single blood draw, with a low rate of false positive results (high specificity). The company has since selected methylation as its preferred approach and has developed a methylation sequencing blood test that preferentially targets the most informative regions of the genome to detect the presence of multiple types of cancer and identify where in the body the cancer originated.

DNA methylation is a natural process used by cells to regulate gene expression. GRAIL’s methylation technology uses machine learning algorithms to both detect the presence of cancer and identify the tumor’s tissue of origin when cancer is present.

The blood test is currently being evaluated in the second pre-planned sub-study of CCGA. New results from CCGA will be presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting, including data on the ability of the company’s methylation technology to identify the tissue of origin where cancer is present. An analysis of survival of participants whose cancer was detected by the methylation technology, compared with those whose cancer was not detected by the technology, will also be presented.

GRAIL is conducting what the company believes to be one of the largest clinical research programs ever pursued in genomic medicine. The program consists of three large-scale studies designed to enroll approximately 165,000 participants to create an atlas of genomic cancer signals in the blood, and to develop and evaluate GRAIL’s blood test for the early detection of multiple cancer types. Approximately 115,000 participants have been enrolled to date. The three studies are:

  • CCGA study: a prospective, observational, longitudinal study that has completed enrollment of approximately 15,000 people with and without cancer across 142 sites in the U.S. and Canada. GRAIL is conducting three pre-planned sub-studies within CCGA to discover, train, and validate its multi-cancer early detection test.
  • STRIVE study: a prospective, observational, longitudinal study designed for clinical validation of the ability of GRAIL’s multi-cancer test to detect breast cancer. This study enrolled a population of 10,000 women at the time of their screening mammograms.
  • SUMMIT study: a prospective, observational, longitudinal cohort study that is enrolling participants in London, UK, in an effort to detect lung cancer. This study is designed to enroll approximately 500,000 men and women who do not have a cancer diagnosis at the time of enrollment. About half of these participants will be at high risk for lung cancer due to lifestyle factors such as cigarette smoking, and the other half will not be at high risk.

Read the original press release here.