FDA approves Silicon Valley company’s blood test for colorectal cancer screening among average-risk adults in the US

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The maker of the test, Palo Alto-based biotechnology company Guardant Health, announced Monday that this is the first blood test to be approved by the FDA as a primary screening option for colorect…

The US Food and Drug Administration has approved the company Guardant Health’s Shield blood test for colorectal cancer screening in adults, 45 and older, who are at average risk for the disease. The US Food and Drug Administration has approved a blood test to be used for colorectal cancer screening among average-risk adults 45 and older.

In the United States, colorectal cancer is the second most common cause of cancer deaths, and this year more than 53,000 people are expected to die from the disease, according to the Current options for colorectal cancer screening for people at average risk include a stool-based test done either annually or every three years; a traditional colonoscopy every 10 years; a virtual colonoscopy every five years; or a sigmoidoscopy procedure, which involves using a tube-like instrument called an endoscope to examine the lower part of the colon, every five years.

The test was found to have around 83% sensitivity and 90% specificity in a study, which included nearly 8,000 people, published in March in the. Sensitivity refers to a test’s ability to accurately identify people with disease, designating them as positive. Specificity refers to its ability to accurately designate people without a disease as negative.

About 90% of the study participants without advanced colorectal cancer or precancerous lesions tested negative on the blood test, compared with about 10% who had a false positive test result.

 

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