{"entity":{"id":"nucleix","kind":"company","name":"Nucleix","aka":[],"tldr":"Nucleix makes urine and blood tests that read chemical marks on DNA to spot bladder cancer coming back and, in development, to find lung cancer early.","summary":"Nucleix, based in Rehovot, Israel with a US office in San Diego, develops methylation-based liquid biopsy tests on its EpiCheck platform, which uses PCR and next-generation sequencing to detect disease-specific DNA methylation changes. Bladder EpiCheck is a urine test analysing 15 methylation markers for surveillance of non-muscle invasive bladder cancer recurrence alongside cystoscopy; it is CE-marked for primary and recurrent bladder and upper tract urothelial cancer and received FDA 510(k) clearance in May 2023, the first methylation-based urine qPCR test cleared for this use. A. Menarini Diagnostics distributes it in Europe under a 2024 partnership, with pivotal data published in 2024 and 2025. Lung EpiCheck, a blood test for early detection of lung cancer in high-risk individuals, is in development. In April 2021 the company raised $55 million led by RA Capital Management to advance it.","asOf":"2026-09-10","links":[{"label":"Official website","url":"https://nucleix.com/"},{"label":"FDA 510(k) clearance for Bladder EpiCheck (May 2023)","url":"https://nucleix.com/wp-content/uploads/2023/05/PR_Nucleix_Bladder-EpiCheck-FDA-Clearance.pdf"},{"label":"$55 million financing (April 2021)","url":"https://nucleix.com/blog/news_and_events/nucleix-secures-55-million-funding-led-by-ra-capital-management-and-additional-prominent-life-science-investors-to-advance-lung-epicheck-for-early-detection-of-lung-cancer/"}],"tags":[],"related":[],"cancers":["urothelial","nsclc"],"sections":["diagnostics","early-detection"],"technologies":["methylation-profiling","liquid-biopsy"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["The 2021 release does not name the round; recorded as Series C on the basis that it followed earlier rounds, treat the label as uncertain. Founding year not sourced."],"hq":"Rehovot","country":"IL","companyType":"diagnostics","website":"https://nucleix.com/","stage":"growth","investors":["ra-capital"],"funding":[{"round":"Series C","year":2021,"amountUsd":55000000,"source":"https://nucleix.com/blog/news_and_events/nucleix-secures-55-million-funding-led-by-ra-capital-management-and-additional-prominent-life-science-investors-to-advance-lung-epicheck-for-early-detection-of-lung-cancer/","note":"Round name not given in the release; $55 million led by RA Capital Management, April 2021."}]},"route":"/companies/nucleix/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"section":[{"id":"diagnostics","kind":"section","name":"Diagnostics & Biomarkers","route":"/fronts/diagnostics/"},{"id":"early-detection","kind":"section","name":"Early Detection & Screening","route":"/fronts/early-detection/"}],"technology":[{"id":"bladder-epicheck","kind":"technology","name":"Bladder EpiCheck urine methylation test","route":"/technologies/bladder-epicheck/"},{"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":"urine-bladder-cancer-tests","kind":"technology","name":"Urine tests for bladder cancer (cytology, FISH, RNA and methylation)","route":"/technologies/urine-bladder-cancer-tests/"}],"company":[{"id":"ra-capital","kind":"company","name":"RA Capital Management","route":"/companies/ra-capital/"}]}}