Blood Test for Colorectal Cancer Gets FDA Approval

Key Takeaways

• The U.S. Food and Drug Administration has approved the first blood test for colorectal cancer, called Shield.
• The test accurately detects colorectal cancer 83 percent of the time.
• Doctors hope the test will increase the number of people getting screened for colorectal cancer above the current 70 percent mark.

Patients who are uncomfortable with colonoscopy and other screening tests for colorectal cancer have a new option: a blood test called Shield. The U.S. Food and Drug Administration (FDA) approved Shield as a primary screening option for colorectal cancer earlier this week.

Studies found that Shield accurately detected colorectal cancer 83 percent of the time, or in about 5 out of every 6 people.

The Shield test needs to be repeated every three years.

Will Insurance Cover the New Colorectal Cancer Blood Test?

The FDA decision means Shield meets the performance requirements for Medicare coverage. Once coverage is established (expected in a few days), eligible Medicare Part B beneficiaries will have no out-of-pocket cost, says Mike Weist, spokesperson for Guardant Health, the company that produces Shield.

"The out-of-pocket cost for Medicare Advantage beneficiaries will vary depending on their individual plans. For patients with commercial insurance plans, the cost of the Shield test may vary depending on the individual plan coverage," he says.

Doctors can already prescribe Shield as a lab test with an out-of-pocket cost of $895.

The new self-pay price for the FDA-approved version will be available when the test is launched commercially, which is expected to happen within the next week, says Weist.

"Commercial insurance coverage for patients eligible for colorectal screening will continue to expand following anticipated future guideline inclusion by the American Cancer Society and the U.S. Preventive Services Task Force," Weist says.

New Screening Test Can Be Part of Typical Blood Work at a Doctor's Visit

The blood test may help increase the number of people who are screened for colorectal cancer, says Julius M. Wilder, MD, PhD , gastroenterologist and hepatologist at Duke Health in Durham, North Carolina.

"We are far below where we should be in terms of colon cancer screening, and this blood test allows for providers to incorporate colon cancer screening into the other typical blood work done as part of the usual physician visit," says Dr. Wilder.

Colorectal cancer is the third most common cancer and the second leading cause of cancer-related death.

It's estimated that only about 70 percent of people currently complete the appropriate screening for colorectal cancer.

Experts agree that early detection of colorectal cancer reduces the risk of death. When found at an early stage , before it has spread, colorectal cancer has a five-year relative survival rate of 91 percent. If the cancer has spread to distant parts of the body, the five-year survival rate drops to 13 percent.

How Does the Blood Test Compare to Other Options?

A colonoscopy is the most reliable way to identify polyps and colorectal cancer, with accuracy of 90 to 95 percent according to the American College of Surgeons.

But a colonoscopy requires advance prep - following a special diet, cleaning out your bowel with a combination of liquids or powder laxatives, and then undergoing the procedure itself, which requires sedatives, anesthesia or pain medicine, and procuring a ride home.

If the procedure reveals nothing unusual, it only needs to be repeated every 10 years.

In addition, there are two main at-home tests for colorectal cancer:

• FIT (fecal immunochemical test) is about 79 percent accurate in detecting colon cancer. The test comes as a kit with instructions and materials to collect a small amount of fecal matter (poop) to be sent to the lab for analysis. It's recommended that the test be repeated every one to two years.

• Cologuard (fecal DNA testing) has a 92 percent accuracy rate. It also involves collecting a poop sample and mailing it off. The test should be repeated every three years.

The New Blood Test Does Not Make Colonoscopy Obsolete

People should keep in mind that if the blood test is positive for colorectal cancer, they will still need to undergo a colonoscopy, says Wilder.

"Furthermore, this blood test is for individuals undergoing average risk screening for colon cancer. Individuals considered to be at high risk for colon cancer, including individuals with a family history of colon cancer or symptoms such as blood in their stool, should undergo a colonoscopy," he says.

And although Shield accurately detects colorectal cancer 83 percent of the time, it only identifies precancerous lesions 13 percent of the time.

Also called polyps, these can be especially apt to appear in older adults. Most are benign, or noncancerous, but sometimes polyps can change into cancer - usually over many years. One benefit of a colonoscopy is that doctors can remove precancerous polyps during the procedure.

Bottom Line: The New Blood Test Will Help in the Fight Against Cancer

For the many people who are hesitant to get a colonoscopy or collect a stool sample at home for testing, Shield will be a very useful addition, says Wilder.

"This blood test will make it easier for everyone to be screened, hence allowing for more people to be screened, and hopefully detect colon cancer or more advanced polyps earlier, which will significantly improve survival," he says.

Editorial Sources and Fact-Checking

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Sources

1. Guardant Health's Shield Blood Test Approved by FDA as a Primary Screening Option, Clearing Path for Medicare Reimbursement and a New Era of Colorectal Cancer Screening. Guardant . July 29, 2024.
2. Chung DC et al. A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening. The New England Journal of Medicine . March 14, 2024.
3. Blood Test for Colon Cancer Gets U.S. Regulator Approval. PBS News . July 29, 2024.
4. Key Statistics for Colorectal Cancer. American Cancer Society . January 29, 2024.
5. Richardson LC et al. Adults Who Have Never Been Screened for Colorectal Cancer, Behavioral Risk Factor Surveillance System, 2012 and 2020. Preventing Chronic Disease . April 21, 2022.
6. Survival Rates for Colorectal Cancer. American Cancer Society . January 29, 2024.
7. Colonoscopy. American College of Surgeons . July 2023.
8. Colonoscopy. National Institute of Diabetes and Digestive and Kidney Diseases . August 2023.
9. At-Home Colorectal Cancer Screening: What You Should Know. Cedars-Sinai . May 8, 2021.
10. Imperiale TF et al. Multitarget Stool DNA Testing for Colorectal-Cancer Screening. The New England Journal of Medicine . April 3, 2014.
11. Colon Polyps. Cleveland Clinic . September 25, 2023.

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Becky Upham

Author

Becky Upham has been professionally involved in health and wellness for almost 20 years. She's been a race director, a recruiter for Team in Training for the Leukemia & Lymphoma Society, a salesperson for a major pharmaceutical company, a blogger for Moogfest, a communications manager for Mission Health, a fitness instructor, and a health coach.

She majored in English at the University of North Carolina and has a master's in English writing from Hollins University.

Upham enjoys teaching cycling classes, running, reading fiction, and making playlists.

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