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We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Key takeaways: The panel voted 7 to 2 with one abstention that the benefits of Galleri outweigh potential risks for multicancer detection. Clinical efficacy remains uncertain with long-term outcome data still needed. An FDA advisory panel expressed support for a blood test designed to detect early signs of multiple cancers, including some for which no screening alternative exists. Members of the Medical Devices Advisory Committee\u2019s Molecular and Clinical Genetics Panel voted 7 to 2 with one abstention that the benefits of Galleri (Grail Inc.) outweigh the potential risks for adults age 50 years or older, the population for which the test\u2019s developer is seeking approval in the United States.
An FDA advisory panel expressed support for a blood test designed to detect early signs of multiple cancers.
In separate votes, the panel unanimously agreed Galleri is safe for use in this population but was split on whether the test is effective. On the latter question, six members voted yes and four voted no. The FDA is not obligated to follow advisory committee recommendations when making decisions about approval but often does so. \u201cWhat drove my vote was the ability to screen for cancers that previously have not been \u2018screenable.\u2019 I think that would be a major contribution,\u201d said panel member Danil V. Makarov, MD, a board-certified urologist at NYU Langone Health who endorsed the test\u2019s benefit-risk ratio. However, several panel members \u2014 even some who cast favorable votes \u2014 expressed caution, citing a lack of long-term data to show whether the test\u2019s identification of cancer signals translates to improved clinical outcomes. If the test ultimately is approved, Makarov said he hopes \u201crobust post-market surveillance\u201d will be conducted. Victor van Berkel, MD, PhD, thoracic surgeon and associate professor in the department of cardiovascular and thoracic surgery at University of Louisville School of Medicine \u2014 said he considered abstaining before ultimately casting a favorable vote. \u201cI suppose the reason I hedge toward \u2018yes\u2019 is because I think, in the years ahead, it probably will be proven to have benefits that outweigh the risks, specifically when it comes to cancers for which we don\u2019t have good tests,\u201d van Berkel said. \u201cI think even a marginally successful test, if we can find more early-stage cancers that we can\u2019t screen for currently, will end up having benefit. But I don\u2019t know if that has been proven yet. Perhaps my \u2018yes\u2019 is a hopeful rather than an accurate one.\u201d \u2018Not a replacement\u2019 Only about one in seven cancers in the United States are detected through guideline-recommended screening, according to data from NORC at University of Chicago. Malignancies for which no screening test exists account for approximately 70% of cancer deaths. Multicancer early detection (MCED) tests that measure biologic signals in blood, urine or other body fluids have been touted as one potential strategy to improve detection of those cancers and possibly identify them prior to metastatic spread. Galleri \u2014 available only with a physician prescription \u2014 is a next-generation sequencing-based in vitro diagnostic test intended to detect cancer-specific methylation patterns in cell-free DNA. Because it is investigational, most people who use the test pay out-of-pocket. A premarket approval application for Galleri is the first submitted to the FDA for an MCED, and approval likely would prompt insurance companies to cover the test. The Medical Devices Advisory Committee\u2019s Molecular and Clinical Genetics Panel dedicated a day-long meeting Sept. 23 to the application. Nearly two dozen physicians and advocates \u2014 as well as members of the public who shared stories about how the test detected signals that led to diagnosis of early-stage cancers while they were asymptomatic and otherwise healthy \u2014 spoke during the session. The session also included review and discussion of data from two large studies that evaluated the performance of Galleri. The NHS-Galleri trial \u2014 the first randomized trial to evaluate whether an MCED test using a blood sample could result in diagnosis of cancer at earlier stages \u2014 included adults in the U.K. aged 50 to 77 years with no clinical suspicion of cancer. Researchers evaluated whether the addition of 3 years of annual testing with Galleri to standard screening could result in detection of 12 prespecified cancers at earlier stages \u2014 specifically increasing the proportion diagnosed at stage I or stage II while decreasing the number diagnosed at stage III or stage IV. The cancer types evaluated included bladder, esophageal, head and neck, ovarian, pancreatic and stomach cancers. As Healio previously reported, findings presented at last year\u2019s ASCO Annual Meeting and later published in The New England Journal of Medicine showed NHS-Galleri did not meet its primary endpoint, failing to show a reduction in stage III\/stage IV diagnoses of the prespecified cancer types after three annual screening rounds (HR = 1.03; 95% CI, 0.92-1.14). Analyses of secondary endpoints showed a reduction in stage IV cancers alone, as well as a 16% increase in detection of stage I\/stage II cancers among trial participants who underwent annual screening with Galleri for 3 years compared with those who received usual care (HR = 1.16; 95% CI, 1.03-1.3). The test exhibited a specificity of 99.55% and a positive predictive value of 52%. Galleri has been designed to predict the site in which a cancer signal originated. When the test reported one site of origin, it proved correct in 87% of cases. When the test reported the top two most probable sites of origin, it proved correct in 92.5% of cases. A second prospective study \u2014 PATHFINDER 2 \u2014 evaluated the safety and performance of Galleri in combination with standard cancer screenings in<\/p>\n","protected":false},"author":1,"featured_media":2941,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-3799","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=\/wp\/v2\/posts\/3799","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=3799"}],"version-history":[{"count":0,"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=\/wp\/v2\/posts\/3799\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=\/wp\/v2\/media\/2941"}],"wp:attachment":[{"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3799"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3799"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3799"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
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