Guardant Health said its blood test to detect a cancer that starts in the colon or rectum got an approval from the US Food and Drug Administration, sending the company\u2019s shares up 16% in premarket trading on Monday.<\/p>\n
The test, known as Shield, has been available in the US as a laboratory-developed test (LDT) since 2022 and is available for a self-pay price of $895.<\/p>\n
LDTs are designed, manufactured and used within a single laboratory, but the FDA\u2019s approval takes Shield a step closer to becoming the first blood test for colorectal cancer (CRC) screening that is eligible for Medicare insurance coverage for older adults.<\/p>\n
Guardant did not provide the self-pay price of the FDA-approved version of the test. If covered under certain Medicare plans for people age 65 and older, patients usually do not have to bear out-of-pocket cost for such tests.<\/p>\n
Advisers to the FDA voted to approve the blood test in May, with the regulator allowing its use for adults age 45 years and older.<\/p>\n
Blood-based tests are more convenient than feces-based tests, such as Exact Sciences\u2019 Cologuard, for cancer screening.<\/p>\n
The FDA decision helps Shield test target more than 50 million people who remain unscreened, Leerink Partners analyst Puneet Souda said.<\/p>\n
Shield\u2019s approval is the second for a blood-based test for CRC screening in the United States after Epigenomics\u2019 Epi proColon, which was approved in 2016 but failed to meet the government\u2019s 74% or more sensitivity criterion for Medicare coverage.<\/p>\n
According to the FDA\u2019s documents, a study showed Guardant\u2019s Shield test detected 83% of colorectal cancers. Exact Sciences\u2019 stool test Cologuard had a 92.3% sensitivity rate.<\/p>\n
The FDA’s approval of the Shield test is a significant step forward in the fight against colon and rectal cancer. With its convenience and high accuracy, the Shield test has the potential to increase screening rates and save lives.<\/p>\n
Q: What is the Shield test?<\/strong> Q: How does the Shield test work?<\/strong> Q: Is the Shield test covered by Medicare?<\/strong> Q: How does the Shield test compare to other tests?<\/strong> Q: What does the future hold for the Shield test?<\/strong> FDA Approves Blood-Based Colon, Rectal Cancer Test Guardant Health’s Shield Test Receives FDA Approval Guardant Health said its blood test to detect a cancer that starts in the colon or rectum got an approval from the US Food and Drug Administration, sending the company\u2019s shares up 16% in premarket trading on Monday. What is the […]<\/p>\n","protected":false},"author":6,"featured_media":8978,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"rank_math_lock_modified_date":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[22],"tags":[],"class_list":{"0":"post-8977","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-health-wellness"},"jetpack_featured_media_url":"https:\/\/i3.wp.com\/nypost.com\/wp-content\/uploads\/sites\/2\/2024\/07\/signage-seen-outside-food-drug-86340929.jpg?quality=75&strip=all&w=1024&w=1024&resize=1024,682&ssl=1","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/citystuff.com\/new-york\/wp-json\/wp\/v2\/posts\/8977"}],"collection":[{"href":"https:\/\/citystuff.com\/new-york\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/citystuff.com\/new-york\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/citystuff.com\/new-york\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/citystuff.com\/new-york\/wp-json\/wp\/v2\/comments?post=8977"}],"version-history":[{"count":1,"href":"https:\/\/citystuff.com\/new-york\/wp-json\/wp\/v2\/posts\/8977\/revisions"}],"predecessor-version":[{"id":8979,"href":"https:\/\/citystuff.com\/new-york\/wp-json\/wp\/v2\/posts\/8977\/revisions\/8979"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/citystuff.com\/new-york\/wp-json\/wp\/v2\/media\/8978"}],"wp:attachment":[{"href":"https:\/\/citystuff.com\/new-york\/wp-json\/wp\/v2\/media?parent=8977"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/citystuff.com\/new-york\/wp-json\/wp\/v2\/categories?post=8977"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/citystuff.com\/new-york\/wp-json\/wp\/v2\/tags?post=8977"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\nA: The Shield test is a blood-based test that detects a cancer that starts in the colon or rectum.<\/p>\n
\nA: The Shield test uses a blood sample to detect genetic markers that are associated with colon and rectal cancer.<\/p>\n
\nA: The FDA-approved version of the Shield test may be eligible for Medicare insurance coverage for older adults.<\/p>\n
\nA: The Shield test has a sensitivity rate of 83%, compared to 92.3% for Exact Sciences\u2019 stool test Cologuard.<\/p>\n
\nA: The FDA’s approval of the Shield test is a significant step forward, and the company plans to continue to work with regulatory authorities to make the test available to as many people as possible.<\/p>\n","protected":false},"excerpt":{"rendered":"