By Jacqueline Howard | CNN
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.
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 colorectal cancer, and it’s the first approved blood screening test for colorectal cancer that meets requirements for Medicare reimbursement. For patients with commercial insurance plans, the cost of the test may vary depending on their individual plan coverage. The list price for the test has not yet been announced.
“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 Fred Hutchinson Cancer Center, said in a statement Monday released by Guardant Health.
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 American Cancer Society. But about 70% of colorectal cancer deaths can be prevented with increased screening.
The test, called Shield, is expected to launch commercially within the next week and will join other types of colon and rectal cancer screening methods – including colonoscopies and at-home stool tests – as options that health care providers can offer their patients. A simple blood test may be more convenient for some patients while colonoscopies can feel invasive, or at-home stool tests can feel awkward.
“The test, which has an accuracy rate for colon cancer detection similar to stool tests used for early detection of cancer, could offer an alternative for patients who may otherwise decline current screening options,” Grady said in the news release.
Current options for colorectal cancer screening for people at average risk…
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