FDA approves blood test for colon cancer screenings

The FDA has approved a new screening test for colorectal cancer that only requires a sample of blood, The New York Times reported July 29.

The FDA approved the test, which can find cancers when they are early stage and usually curable, on July 29. 

The blood test, created by Palo Alto, Calif.-based Guardant Health, was able to detect 83% of  colorectal cancers in studies, but only 13% of dangerous polyps. Colonoscopies find approximately 95% of these polyps. 

The Shield test will be available to patients within the next week, according to the report.  Guardant will announce its list price at that time. 

Shield is approved for people aged 45 and over who are at average risk for colon cancer. The hope is that, despite detection limitations, the less invasive blood test will encourage more Americans to get screened. The test also showed a 10% false positive rate. 

Currently, as many as 25% to 50% of people who should be undergoing routine colonoscopies are not.

On May 23, an FDA advisory committee recommended that the blood test be approved despite its inability to prevent cancer. 

Guardant said the test meets Medicare’s requirements for coverage.  The out-of-pocket cost for those with commercial insurance or Medicare Advantage will depend on their plan.



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