Cancerguard
Exact Sciences' multi-cancer blood test, sold since 2025 as a lab test that has not been through FDA approval.
Overview
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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Notes
top- 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.
Latest papers
topQuery for this drug: (TITLE:"Cancerguard" OR ABSTRACT:"Cancerguard") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Cancerguard, not a curated reading list.
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