FDA approves blood test for colorectal cancer screening

Editor | Shield HealthCare

07/29/24 8:45 AM PST

Shield is a blood test from Guardant Health for colorectal cancer screening in average-risk individuals 45 and older.

The U.S. Food and Drug Administration (FDA) has approved the first blood test for colorectal cancer (CRC) screening in adults age 45 and older who are at average risk for the disease.

Shield™ Blood Test for CRC Screening

The California-based biotech company Guardant Health, a precision oncology company, recently announced U.S. FDA approval of the company’s Shield™ blood test for CRC screening. Shield is a non-invasive, blood-based screening test that detects alterations associated with colorectal cancer in the blood. It is intended as a screening test for individuals at average risk for the disease, age 45 or older. The Shield blood test is the first blood test to be approved by the FDA as a primary screening option for CRC. It is also the first approved blood test for colorectal cancer screening that meets the requirements for Medicare reimbursement.

The Shield test joins other methods of colon and rectal cancer screenings, such as colonoscopies and at-home stool tests that are sent by mail, providing doctors and patients with a third screening option. By providing a third screening option, Guardant Health hopes to capture the interest of patients who decline at-home stool tests and colonoscopies as awkward or invasive.

“This is a promising step toward making more convenient tools available to detect colorectal cancer early while it is more easily treated,” said William M. Grady, MD, a gastroenterologist at Fred Hutchinson Cancer Center quoted in the press release.

“The test, which has an accuracy rate for colon cancer detection similar to stool tests used for early detection of cancer, could offer an alternative for patients who may otherwise decline current screening options.”

Colon Cancer on the Rise

Colorectal cancer is the second-leading cause of cancer-related death in the U.S., even though it is highly treatable if caught early. The American Cancer Society estimates that the disease will be diagnosed in more than 150,000 new people in 2024 and will claim 53,000 lives this year alone.

Early-onset colorectal cancer — CRC affecting younger people — is also on the rise. In 2002, the average age for a colorectal cancer diagnosis was 72. By 2019, it was down to 66. In less than 20 years, new CRC cases in people under 55 nearly doubled.

CRC Screening Challenges

Where does this new screening test fit in? More than three out of four individuals who die from CRC are not up to date with their screening. Early detection is critical. When colon cancer is found at an early stage, before it has spread, the five-year relative survival rate is 91%. If the cancer has spread to distant parts of the body, the five-year relative survival rate drops to 14%.

More than one in three eligible Americans between 50-75 years of age (over 50 million people) are currently not completing their recommended CRC screening, according to the National Colorectal Cancer Roundtable.

“The persistent gap in colorectal cancer screening rates shows that the existing screening options do not appeal to millions of people,” said Daniel Chung, MD, gastroenterologist at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School.

“The FDA’s approval of the Shield blood test marks a tremendous leap forward, offering a compelling new solution to close this gap. This decision will help make screening tests more broadly accessible and propel blood-based testing and CRC screening into a new era. With increased screening rates and early cancer detection, many more lives can be saved.”

Path to FDA Approval

The Shield blood test is the result of more than a decade of research and development by Guardant Health and its partner health organizations. It was introduced commercially in May 2022 and has shown the potential to fill an adherence gap on the patient side. Since its introduction, more than 90% of patients who were prescribed the test in a real-world clinical setting completed it. In contrast, studies show the adherence rate of patients who are prescribed other screening methods, such as colonoscopy or a stool test, is 71% or less. With a simple blood draw taken the same day as the screening recommendation is provided, patients have less responsibility and less to coordinate. For some patients with tight schedules, it can be challenging to schedule, prepare for, and complete a colonoscopy. The simpler steps involved for an in-home stool test still require patient execution within a limited time frame.

“Most people in my situation know we’re supposed to get screened for colon cancer,” said Dennis Barnes, a 55-year-old attorney whose physician had recommended a colonoscopy. But despite his best intentions, he had never scheduled one. “It’s hard to find the time to schedule it if you have a busy life and a demanding job,” he said. When his doctor told him about Shield, he agreed to have the blood test and was fortunate to have the result come back normal. “I realized I had taken quite a risk by waiting so long to screen. The Shield test is a much more pleasant way to screen, and the convenience of it makes getting screened pretty much a no-brainer.”

The FDA decision follows a strong recommendation for approval by an Advisory Committee panel in May 2024. The approval was based on results of ECLIPSE , a 20,000+-patient registrational study evaluating the performance of the test for detecting CRC in average-risk adults. Designed to reflect the diverse population of the U.S., the study was conducted at more than 200 clinical trial sites in rural and urban communities across 37 states. Results from the study, published in the March 14, 2024, issue of The New England Journal of Medicine, showed that Shield demonstrated 83% sensitivity for the detection of CRC, with 90% specificity for advanced neoplasia. This performance is within range of current guideline-recommended non-invasive screening methods, in which overall CRC sensitivity ranges from 74% to 92%.

How to Request a Screening

Shield is available for eligible individuals by prescription through a doctor or other healthcare professional and is expected to be covered for eligible Medicare beneficiaries. Commercial insurance coverage for patients eligible for CRC screening will continue to expand following anticipated future guideline inclusion by the American Cancer Society and the U.S. Preventive Services Task Force (USPSTF).

For complete product information about the Shield blood test for CRC screening, including full safety information, visit ShieldCancerScreen.com.

About the Shield Blood Test

Shield is a non-invasive, blood-based screening test that detects alterations associated with colorectal cancer in the blood. It is intended as a screening test for individuals at average risk for the disease, age 45 or older, and is not intended for individuals at high risk for colorectal cancer. The Shield test can be considered in a manner similar to guideline-recommended non-invasive CRC screening options and can be completed during any healthcare visit. A positive Shield result raises concern for the presence of colorectal cancer or advanced adenoma and the patient should be referred for colonoscopy evaluation.

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