{"entity":{"id":"cancerguard","kind":"drug","name":"Cancerguard","aka":[],"tldr":"Exact Sciences' multi-cancer blood test, sold since 2025 as a lab test that has not been through FDA approval.","summary":"Cancerguard launched in September 2025 as a laboratory-developed test priced for self-pay, built on the multi-biomarker approach validated in the Falcon Registry and DETECT-A studies (the latter, with Johns Hopkins, was the first prospective interventional study of a multi-cancer blood test). Unlike Galleri it does not predict where a cancer is, so a positive result triggers whole-body imaging. As an LDT it is regulated through CLIA rather than the FDA, a status confirmed when the FDA's 2024 LDT rule was vacated in 2025. No randomised trial has yet shown that a multi-cancer blood test reduces deaths.","status":"emerging","asOf":"2026-09-10","links":[{"label":"Exact Sciences: Cancerguard","url":"https://www.exactsciences.com/"}],"tags":["test"],"related":["galleri","shield"],"cancers":[],"sections":[],"technologies":["mced","liquid-biopsy","methylation-profiling"],"targets":[],"drugs":[],"companies":["exact-sciences"],"institutions":[],"pathways":[],"terms":["ppv","screening","fda-ldt-rule"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["What a result means: a positive signal starts a diagnostic work-up with scans; most people with a positive result will not turn out to have cancer, and a negative result does not replace mammograms, colonoscopy or other proven screening."],"brand":"Cancerguard","modality":"Multi-cancer early detection blood test (laboratory-developed)","mechanism":"Plasma assay combining cell-free DNA methylation and protein biomarkers across multiple classes, reporting a cancer signal without a tissue-of-origin call, followed by imaging work-up.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/cancerguard/","neighbours":{"drug":[{"id":"galleri","kind":"drug","name":"Galleri","route":"/drugs/galleri/"},{"id":"shield","kind":"drug","name":"Shield","route":"/drugs/shield/"}],"technology":[{"id":"methylation-profiling","kind":"technology","name":"DNA methylation profiling","route":"/technologies/methylation-profiling/"},{"id":"liquid-biopsy","kind":"technology","name":"Liquid biopsy (ctDNA)","route":"/technologies/liquid-biopsy/"},{"id":"mced","kind":"technology","name":"Multi-cancer early detection (MCED)","route":"/technologies/mced/"}],"company":[{"id":"exact-sciences","kind":"company","name":"Exact Sciences (Abbott)","route":"/companies/exact-sciences/"}],"term":[{"id":"fda-ldt-rule","kind":"term","name":"FDA laboratory-developed test (LDT) rule","route":"/terms/fda-ldt-rule/"},{"id":"ppv","kind":"term","name":"Positive predictive value (PPV)","route":"/terms/ppv/"},{"id":"screening","kind":"term","name":"Screening","route":"/terms/screening/"}]}}