New, early data from Grail showed its liquid biopsy test not only was able to detect the presence of 12 different kinds of early-stage cancer but could also identify the disease’s location within the body before it spreads using signatures found in the bloodstream.
The test also demonstrated a very low rate of false positives, at 1% or less. The former Fierce 15 winner presented the returns from a substudy of its Circulating Cell-free Genome Atlas (CCGA) project at this year’s annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
Detection rates varied among the dozen prespecified and potentially fatal types of tumors in earlier stages—from 59% in lung cancers up to 86% in cancers of the head and neck. When analyzed by cancer stage, the test showed sensitivity rates of 34%, 77%, 84% and 92% across all tumor types, from stage I to stage IV, respectively.
Additionally, tissue-of-origin results were provided for 94% of all cancers detected, with correct identifications being made in 90% of cases. With these findings, the company now plans to move its multicancer blood test further toward the market.
“Data being presented at ASCO suggest Grail’s test preferentially detects the most lethal cancers and can detect tumors when they are still localized and amenable to successful treatment,” Grail’s founder and director Rick Klausner said in a statement.
RELATED: Grail nets FDA breakthrough designation, turns eye toward DNA methylation for early cancer detection
“The high detection rate of stage II cancers at 77 percent in the group of 12 deadly cancers is particularly compelling and supports the potential benefit of our multi-cancer approach,” said Klausner, a former director of the National Institutes of Health's National Cancer Institute.
The study’s 12 cancer types—and the test’s sensitivity rates for detecting stage I-III disease—included anorectal (79%), colorectal (74%), esophageal (76%), gastric (78%), head and neck (86%), hormone receptor negative breast (64%), liver (68%), lung (59%), ovarian (67%) and pancreatic (78%) tumors, as well as multiple myeloma (71%) and lymphomas (70%), excluding leukemias.
According to Grail, these cancer types account for nearly two-thirds of all cancer deaths in the U.S., with the test demonstrating an overall detection rate of 76% across all stages.
“These very promising data indicate that a highly specific blood test for early cancer detection is approaching reality,” said study investigator Minetta Liu, a research chair and professor in the department of oncology at the Mayo Clinic.
“The exceptional accuracy in determining the tissue of origin across all stages for those malignancies with significant cancer-specific mortality suggests that, if a cancer is detected, the test will inform where the tumor originated in the majority of cases,” Liu said. “This factor is critical to streamline the clinical workup.”
In addition, the low rate of false positives is a particular high point for the company.
“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,” Klausner said.
The data come from a preplanned substudy of the ongoing CCGA trial, which has enrolled about 15,000 participants with and without cancer across the U.S. and Canada. The results reported at ASCO this year are from an initial analysis of the substudy’s training phase, involving 1,422 patients across more than 20 cancer types as well as 879 participants without any diagnosis.
At last year’s ASCO meeting, Grail presented initial CCGA data demonstrating support of its concept: Its sequencing assays delivered detection rates ranging from 38% to 51% in 127 participants with early-stage lung cancers—including adenocarcinoma, squamous cell and small cell lung tumors—at 98% specificity.
Since then, Grail has refined its approach, targeting measures of DNA methylation—the body’s natural processes of regulating gene expression—instead of the genetic code itself. Methylation can present abnormal patterns in cancer, which can contribute to disease growth by silencing tumor-suppressing genes.