FDA approves blood-based test screens for colon cancer

( NewsNation ) — The U.S. Food and Drug Administration has approved a blood test to detect colon cancer .

Guardant Health’s blood test, known as Shield , was approved for adults aged 45 years and older. This non-invasive screening test detects alterations in the blood associated with colorectal cancer. It’s intended as a screening test for people at average risk for the disease, not those at high risk, according to Guardant.

“The FDA approval of the Shield test is a significant victory for patients and an important milestone in Guardant Health’s mission to conquer cancer with data. Shield can help improve colorectal cancer screening rates so we can detect more cancers at an early stage, when they are treatable,” said AmirAli Talasaz , co-CEO of Guardant Health.

Shield has been available in the U.S. as a laboratory-developed test since 2022 and is available for a self-pay price of $895. It’s expected to increase private and government insurance coverage with FDA approval.

The test looks for DNA fragments from tumor cells and precancerous growths. In a study published in March, the test caught 83% of the cancers but very few of the precancerous growths found by colonoscopy, the gold standard for colon cancer screening . The test missed 17% of cancers, performance that is on par with stool-based tests.

Besides spotting tumors, colonoscopies can prevent the disease by removing precancerous growths called polyps.

The annual rate of U.S. colon cancer screening is about 60%, below the 80% of age-eligible adults goal set by the American Cancer Society and other groups.

The Associated Press contributed to this report.

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