FDA approves colorectal cancer blood test

Patients now have a new option for colorectal cancer detection.

The Food and Drug Administration approved a blood test that can detect colorectal cancer, CBS News reported.

It’s called Shield and was developed by Guardant Health Inc.

The test was approved by the FDA for adults aged 45 and older who are at average risk of cancer.

It works because large polyps, which can turn into cancer, shed DNA fragments that can be detected in the blood, The New York Times reported.

The company said it is the first blood test that the FDA has approved to be a primary screening for colorectal cancer. It is also the first that will meet Medicare requirements.

The test found 83% of colorectal cancers while a stool test called Cologuard had a 92.3% sensitivity rate, Reuters reported.

But Shield, according to The New York Times, can find colorectal cancer when it is at an early stage and curable. However, it does not find precancerous growths like a colonoscopy can.

Typically people have colonoscopies performed but the test is considered by some as inconvenient, Reuters reported. The blood test only found 13% of large polyps compared to 95% with a colonoscopy.

The American Cancer Society said the testing recommendation currently is fecal tests every three years and a colonoscopy every 10 years.

Still, it is hoped that more people will undergo the blood test and be screened, the Times reported.

The blood test is not new. It has been around since 2022 in the U.S. but was only a self-pay option, costing $895 and not covered by Medicare, according to Reuters.

It is estimated that as many as 53,000 Americans will die from colorectal cancer, according to the American Cancer Society.

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