{"entity":{"id":"novelna-protein-test","kind":"drug","name":"Novelna sex-specific protein test","aka":[],"tldr":"An experimental blood test that reads a handful of proteins, with different panels for men and women, to find many early cancers; so far it has been tried only on a few hundred stored samples.","summary":"In Novelna's discovery study (Budnik et al., BMJ Oncology 2024), plasma from 440 people, healthy or with 18 early-stage solid tumours, was profiled for more than 3,000 proteins. Ten-protein sex-specific panels reached areas under the curve of 0.98 in men and 0.983 in women and, at stage I and 99% specificity, identified 93% of cancers among men and 84% among women, with wide confidence intervals; 150-protein panels identified tissue of origin in more than 80% for most cancers. The company's website claims higher accuracy than existing tests without figures; trade press reports the company saying it could be made for under $100. No regulatory status, availability, price or registered trial was found.","status":"emerging","asOf":"2026-10-29","links":[{"label":"Budnik et al., BMJ Oncology 2024","url":"https://doi.org/10.1136/bmjonc-2023-000073"}],"tags":["test","mced","evidence:insufficient"],"related":[],"cancers":[],"sections":[],"technologies":["mced","liquid-biopsy","proteomics"],"targets":[],"drugs":[],"companies":["novelna"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-budnik-novelna-proteomics-bmj-oncol-2024"],"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.","Small discovery set: figures this high usually fall in independent validation.","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":"Novelna","modality":"Multi-cancer blood test in development (plasma proteins, proximity extension assay)","mechanism":"Two ten-protein detection panels, one for men and one for women, measured in plasma by proximity extension assay, with larger panels to predict the tissue of origin.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/novelna-protein-test/","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":"novelna","kind":"company","name":"Novelna","route":"/companies/novelna/"}],"paper":[{"id":"paper-budnik-novelna-proteomics-bmj-oncol-2024","kind":"paper","name":"Novel proteomics-based plasma test for early detection of multiple cancers in the general population","route":"/key-papers/paper-budnik-novelna-proteomics-bmj-oncol-2024/"}]}}