The New England Journal of Medicine published a groundbreaking study called “A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening.”
The study revealed that the test accurately detected colorectal cancer in 83% of individuals without symptoms who were at an average risk and confirmed to have the disease. However, the study also noted that the test falsely suggested the presence of colon cancer in 10% of cases where colonoscopy showed no signs of the disease.
According to researchers, the blood test’s precision in detecting colorectal cancer is comparable to that of at-home stool tests. This development is significant in creating more accessible screening tools to detect the disease early when treatment is more effective.
Dr. William Grady, a gastroenterologist at Fred Hutchinson Cancer Center in Seattle, is the study’s corresponding author. He highlighted that less than half of individuals aged 45 to 49 opt for screening through stool tests or colonoscopies in certain populations. Grady stated that blood-based screening tests are likely to be better received by individuals compared to colonoscopies and stool tests, potentially leading to higher screening compliance rates and ultimately reducing colorectal cancer-related mortality.
These insights were derived from the ECLIPSE study, a multi-site clinical trial that involved nearly 8,000 participants aged 45 to 84. The trial was spearheaded and financed by Guardant Health Inc., a precision oncology company based in Palo Alto, California. The Shield test confirmed its effectiveness by comparing its results with colonoscopy, which is considered the gold standard of screening. The test identifies colorectal cancer signals in the blood through circulating tumor DNA, utilized in liquid biopsy tests to monitor cancer recurrence post-treatment.
Among the 7,861 individuals in the study, 83.1% of those with colorectal cancer confirmed by colonoscopy tested positive for circulating tumor DNA. The test showed high sensitivity for colorectal cancers, particularly in detecting early-stage malignancies, but had lower sensitivity for advanced precancerous lesions that may develop into cancer over time.
Guardant Health announced in December that the FDA will review the Shield test’s premarket approval application on March 28. The current cash-pay price is $895. Guardant Health spokesman Michael Weist mentioned that upon FDA approval, they expect Medicare coverage. The company will work with private and government payers to determine final pricing, aiming for broad access with minimal costs.
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