Guardant Health announced that its blood test designed to detect colorectal cancer, originating in the colon or rectum, has received approval from the US Food and Drug Administration, causing the company's shares to rise by 16 percent during Monday's premarket trading. The test, named Shield, has been accessible in the US since 2022 as a laboratory-developed test (LDT) and is offered at a self-pay price of $895. LDTs are created, produced, and utilized within a single laboratory, but FDA approval brings Shield closer to becoming the first blood test for colorectal cancer screening eligible for Medicare insurance coverage for older adults. Guardant has not disclosed the self-pay price for the FDA-approved version of the test. If covered under certain Medicare plans for individuals aged 65 and older, patients typically do not incur out-of-pocket costs for such tests.
The FDA's advisers voted to approve the blood test in May, permitting its use for adults aged 45 and older. Blood-based tests offer more convenience compared to feces-based tests, such as Exact Sciences' Cologuard, for cancer screening. The FDA's decision aids Shield in targeting over 50 million unscreened individuals, according to Leerink Partners analyst Puneet Souda. Shield's approval marks the second for a blood-based test for CRC screening in the United States, following Epigenomics' Epi proColon, which was approved in 2016 but did not meet the government's sensitivity criteria for Medicare coverage.
According to the FDA's documents, a study revealed that Guardant's Shield test detected 83 percent of colorectal cancers, while Exact Sciences' stool test Cologuard had a sensitivity rate of 92.3 percent. Colonoscopy is regarded as the gold standard test for CRC. CRC affects approximately 150,000 patients annually in the US and is the second-leading cause of cancer deaths in the country, with over 50,000 fatalities each year, as stated by the FDA.
