The test's maker said the FDA will likely decide on approval later this year.
Guardant Health, Inc. announced the availability of Shield, the company’s first blood-based test for the detection of early-stage colorectal cancer.An FDA advisory panel -- the Medical Devices Advisory Committee -- recommended FDA approval of the Shield blood test on Thursday night, finding it to be safe and effective and that the benefits of use outweighed potential risks.
Here's what you need to know about the tests and how it could help detect colorectal cancer. Guardant Health said it believes the FDA will decide on whether Shield receives premarket approval later in 2024. FDA approval isn't guaranteed. The agency usually agrees with its advisors, but not always.Colorectal cancer starts in the colon or the rectum. It may be referred to as colon cancer or rectal cancer depending on where the cancer originates.
MORE: Blood test could help predict which patients with colon cancer need chemotherapy after surgery: Studyadults aged 45 and older with average risk to be screened for colorectal cancer. This includes a stool test every one to three years or a colonoscopy every 10 years for people that do not have symptoms.Shield detects colorectal cancer by detecting DNA shed by tumors in blood samples. Results takes about two weeks after the samples are received by the laboratory.
"Providing people with this blood test alongside other noninvasive stool tests can increase the rate of colorectal screening and potentially reduce preventable deaths," the statement continued.Despite the high overall sensitivity rate, the clinical trial data indicated Shield test may miss one in 10 people who have precancerous lesions and one in 1,000 people with cancerous lesions.
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