March is Colorectal Cancer (CRC) Awareness Month, and it highlights a disease that affects millions worldwide. The American Cancer Society estimates that 154,270 adults will be diagnosed with CRC and 52,900 adults will die from CRC in 2025. Currently, >1 in 3 adults are not following screening recommendations. This could be because of a lack of gastroenterologists to conduct colonoscopies in regions with low screening, poor education on the importance of screening, or limited access to other testing methods. Thus, emphasizing the use of non-invasive testing methods like blood or stool tests can increase screening and hopefully catch CRC earlier, says GlobalData, a leading data and analytics company.

Selena Yu, Senior Medical Analyst at GlobalData, comments: “Health departments globally need to reevaluate CRC screening programs as more people under the age of 50 are diagnosed with CRC. If more countries follow in the US’ footsteps and drop screening ages to 45 or younger, the CRC test market will expand to accommodate a larger test population. With limited access and potentially long wait times to get colonoscopies, CRC in vitro diagnostics (IVD) tests are necessary to bridge the screening gap.”

Currently, in the US, the recommended screening methods by the US Preventative Task Force are the fecal immunochemical test (FIT), highly sensitive guaiac-based fecal occult blood test, a multi-target stool DNA test (Cologuard), or visual exams by colonoscopy, sigmoidoscopy, or computed tomography colonography. Since this was last updated in 2021, it is missing a new test by Guardant Health that further simplifies CRC screening. The Guardant Health Shield test was approved by the FDA in July 2024 as a primary screening option and is reimbursable by Medicare.

Yu concludes: “Although stool-based testing is more accessible compared to visual exams like colonoscopies, there is still a lack of uptake from patients. Since the Shield test requires a simple blood draw, this can expand access to care for millions of Americans. Physicians can complete a Shield test during a routine office visit with no special preparation or stool handling required.

“The Shield test is particularly exciting because it’s the first of its kind in the US market, and with reimbursement by Medicare, 45 million Medicare beneficiaries are covered. The goal is with increased screening, more individuals will be diagnosed with CRC earlier when it is the most treatable.”