FDA Approves New Blood Test Intended For Screening Colon Cancer

(RTTNews) - The Food and Drug Administration (FDA) has recently approved an innovative blood test developed by Guardant Health, Inc. (GH), known as "Shield," which is specifically intended for screening individuals at average risk for colon cancer.

The implementation of this sophisticated blood test has the potential to greatly enhance survival rates among those diagnosed with colorectal cancer, which is currently the second leading cause of cancer-related fatalities.

The FDA's endorsement of the Shield test was based on a thorough study published in the esteemed New England Journal of Medicine in March 2024. This research highlighted the alarming statistic that more than one-third of individuals eligible for colorectal cancer screening are not current with their screenings.

Dr. William M. Grady, a professor in the Division of Translational Science and Therapeutics at the Fred Hutch Cancer Center and a co-author of the influential study, elaborated on the test in an interview with Medical News Today. He stated, "The Shield blood test is an outstanding screening tool for colorectal cancer, exhibiting accuracy comparable to the commonly used stool-based test, FIT, for cancer detection. It has a false negative rate of merely 13% and a false positive rate of around 10%. Additionally, it can detect 13% of advanced colon adenomas, which are precursors to colorectal cancer."

It is advised that the blood test be conducted every three years, beginning at age 45, which is the recommended age for average-risk individuals to initiate screening. Should the Shield blood test return a positive result, the individual must undergo a colonoscopy for further assessment.

Furthermore, Guardant Health has announced that starting August 1, 2024, Medicare will provide coverage for the Shield blood test. Amir-Ali Talasaz, co-CEO of Guardant Health, said in the press release, "The commercial launch of the Shield test and Medicare coverage make it possible for millions of eligible individuals to access a convenient, more pleasant way to stay up to date with colorectal cancer screening and detect the disease early, when it is more easily treated."