{"entity":{"id":"onetest","kind":"drug","name":"OneTest for Cancer","aka":[],"tldr":"A low-cost blood test from 20/20 BioLabs that measures a panel of protein tumour markers and is sold in the United States as a laboratory test without FDA review.","summary":"20/20 BioLabs (formerly 20/20 GeneSystems) offers OneTest for Cancer from its CLIA/CAP laboratory in Gaithersburg, Maryland. The company says it screens for multiple cancers including lung, pancreatic, ovarian and liver, without stating a total, and a July 2026 company release states that it has not received FDA De Novo authorisation or premarket approval and is offered as a laboratory-developed test. The company's website gives the price as starting at under $200.\n\nThe only peer-reviewed paper found that names the test (Wang et al., Diagnostics 2026) compares capillary and venous blood samples; it is not a study of how well the test finds cancer. No peer-reviewed sensitivity, specificity or positive predictive value for OneTest was found.","status":"emerging","asOf":"2026-10-29","links":[{"label":"20/20 BioLabs","url":"https://www.2020biolabs.com/"},{"label":"Wang et al., Diagnostics 2026 (capillary versus venous samples)","url":"https://doi.org/10.3390/diagnostics16152324"}],"tags":["test","mced","evidence:insufficient"],"related":[],"cancers":[],"sections":[],"technologies":["mced","liquid-biopsy","proteomics"],"targets":[],"drugs":[],"companies":["2020-biolabs"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Evidence grade insufficient for the claim that taking this test reduces late-stage diagnosis or cancer deaths: no randomised trial of it has reported either outcome, and its published performance comes from case-control or single-arm studies. The only randomised result for any multi-cancer test, NHS-Galleri, did not show fewer stage III or IV cancers.","Single protein tumour markers such as CEA and CA-125 are not recommended for screening people without symptoms because they rise in many non-cancer conditions; combining them is the test's premise, and its accuracy in screening has not been published.","What a result means: a positive result is a reason for further tests, not a diagnosis; a negative result does not rule cancer out and does not replace the screening tests that have been shown to work (bowel, breast, cervical and, where eligible, lung screening)."],"brand":"OneTest","modality":"Multi-cancer blood test (panel of serum tumour-associated proteins)","mechanism":"A panel of tumour-associated proteins in serum (12 biomarkers in the company's 2026 sampling study) scored by an algorithm with a cancer type prediction.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[{"country":"US","listPrice":"From under US$200 (company website)","source":"https://www.2020biolabs.com/","asOf":"2026-10-29"}],"regulatoryEvents":[]},"route":"/drugs/onetest/","neighbours":{"technology":[{"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/"},{"id":"proteomics","kind":"technology","name":"Proteomics & phosphoproteomics","route":"/technologies/proteomics/"}],"company":[{"id":"2020-biolabs","kind":"company","name":"20/20 BioLabs","route":"/companies/2020-biolabs/"}]}}