GRAIL Announces Positive New Data with Multi-Cancer Early Detection Blood Test from CCGA Study

GRAIL, a healthcare company focused on the early detection of cancer, today announced new data from its Circulating Cell-free Genome Atlas (CCGA) study that demonstrates the ability of GRAIL’s technology to detect cancer early with a single blood test.

The data revealed that GRAIL’s investigational multi-cancer blood test detected a strong signal for 12 deadly cancer types at early stages with a very high specificity of at least 99 percent (or a false positive rate of 1 percent or less). The test also determined the location where the cancer originated in the body—also known as tissue of origin—with high accuracy.

The test’s sensitivity for the 12 deadly cancer types ranged from 59 to 88 percent at stages I through III, which the oncology community views as the early stages of the disease. A combined analysis of this group of cancers showed robust detection at these stages: 34 percent at stage I, 77 percent at stage II, and 84 percent at stage III. The test also provided a tissue or origin result for 94 percent of all cancers detected, and, of these, the test correctly identified the tissue of origin in 90 percent of cases.

The 12 cancer types studied were anorectal, colorectal, esophageal, gastric, head and neck, hormone receptor-negative breast, liver, lung, ovarian, and pancreatic cancers, as well as multiple myeloma and lymphoid neoplasms. Together, these cancer types represent approximately 63 percent of cancer deaths in the United States. Leukemias were not studied in the test because they are not staged.

“These exciting results suggest we can achieve what we believe are the requirements for a cancer screening blood test, including detection of multiple deadly cancer types at early stages in a single test, high accuracy in determining where the cancer originated, and a very low false positive rate,” said GRAIL CEO Jennifer Cook. “Our improved methylation-based technology has the potential to address gaps that exist with today’s screening options, which are limited to a few cancer types and only screen for one cancer type at a time. Based on the positive data, we plan to advance development of our test toward commercialization.”

Earlier this month, GRAIL’s multi-cancer detection test was granted Breakthrough Device status by the FDA, allowing the company to speed up its development, assessment, and review by the agency.

Minetta Liu, MD, research chair and professor at the Mayo Clinic Department of Oncology, will present the GRAIL data in a poster tomorrow, Saturday, June 1, at the 2019 American Society of Clinical Oncology (ASCO) meeting.

“When we set out on this journey, we knew that to be successful, a blood-based screening tool would need to detect the clinically important cancers and not contribute to overdiagnosis of indolent cancers at the earliest stages,” said Rick Klausner, founder and director of GRAIL. “Data being presented at ASCO suggest GRAIL’s test preferentially detects the most lethal cancers and can detect tumors while they are still localized and amenable to successful treatment.”

GRAIL’s multi-cancer early detection blood test is being evaluated in approximately 4,500 participants for its ability to detect cancer and identify the tissue of origin when cancer is present. The data reported at ASCO are based on an initial analysis of 2,301 participants from the training stage of the sub-study, including 1,422 participants with more than 20 cancer types across all stages and 879 patients without diagnosed cancer. This sub-study is ongoing, and GRAIL plans to present additional results at future medical conferences.

About the CCGA Test

GRAIL is developing a next-generation sequencing (NGS) blood test for the early detection of multiple deadly cancer types. GRAIL’s high-efficiency methylation-based technology preferentially targets the most informative regions of the genome and is designed to use its proprietary database and machine learning algorithms to both detect the presence of cancer and identify the tumor’s tissue of origin. GRAIL’s sequencing database of cancer and non-cancer methylation signatures is believed to be the largest of its kind and covers approximately 30 million methylation sites across the genome.

See the full press release here.

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