The U.S. Food and Drug Administration has approved a new blood test to screen for colon cancer in people considered “average risk.”
Guardant Health, the California company that created the test, said Monday that Shield is the first blood test approved by the FDA as a primary screening option for colorectal cancer and also the first to meets requirements for Medicare reimbursement. It works by detecting tumor DNA and had more than 83% success rate in clinical trials.
“This is a promising step toward making more convenient tools available to detect colorectal cancer early while it is more easily treated,” Dr. William M. Grady, a gastroenterologist at the Fred Hutchinson Cancer Center in Seattle, said in a statement released by Guardant Health.
Colorectal cancer is the second-most common cause of cancer deaths with more than 53,000 expected to die from the illness this year, according to the American Cancer Society. Researchers believe those numbers would be more than halved with improved screening.
A colonoscopy, which is recommended every 10 years, remains the most-accurate method to screen for colon cancer.
The blood test, which is expected to be available to the public within the next week, will offer people an alternative to other screening methods, such as at-home stool tests, Dr. Grady said.
The test is approved for people ages 45 and over, which is when researchers say people should start screening for colon cancer.
