{"entity":{"id":"natera-mced","kind":"drug","name":"Natera multi-cancer early detection assay","aka":[],"tldr":"Natera's blood test in development for several cancers, given FDA Breakthrough Device designation in October 2026 on data from 12 cancer types; no performance figures have been published.","summary":"Natera announced on 9 October 2026 that the FDA had granted Breakthrough Device designation to its multi-cancer early detection assay, which analyses cell-free DNA in blood. The company says the FDA considered sensitivity, specificity and cancer signal origin data from 12 cancer types; it did not name the cancers or give any figures, and the release states that its tests have not been cleared or approved by the FDA. No product name, peer-reviewed paper, registered trial, launch date or price was found on 3 November 2026.","status":"emerging","asOf":"2026-11-03","links":[{"label":"Natera: Breakthrough Device designation (9 October 2026)","url":"https://investor.natera.com/news/news-details/2026/FDA-Grants-Breakthrough-Device-Designation-for-Nateras-Multi-Cancer-Early-Detection-Assay/default.aspx"}],"tags":["test","mced","evidence:insufficient"],"related":["shield-mcd","galleri"],"cancers":[],"sections":[],"technologies":["mced","liquid-biopsy"],"targets":[],"drugs":[],"companies":["natera"],"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.","A Breakthrough designation speeds FDA review; it is not an approval and says nothing about benefit.","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":"Natera MCED","modality":"Multi-cancer early detection blood test in development (cell-free DNA)","mechanism":"Analyses cell-free DNA in blood to screen for several cancers and to predict the cancer signal origin; Natera has not published how.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2026-10-09","type":"designation","region":"US","note":"FDA Breakthrough Device designation for Natera's multi-cancer early detection assay (company announcement)","source":"https://investor.natera.com/news/news-details/2026/FDA-Grants-Breakthrough-Device-Designation-for-Nateras-Multi-Cancer-Early-Detection-Assay/default.aspx"}]},"route":"/drugs/natera-mced/","neighbours":{"drug":[{"id":"galleri","kind":"drug","name":"Galleri","route":"/drugs/galleri/"},{"id":"shield-mcd","kind":"drug","name":"Shield MCD (Shield Multi-Cancer Detection)","route":"/drugs/shield-mcd/"}],"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/"}],"company":[{"id":"natera","kind":"company","name":"Natera","route":"/companies/natera/"}]}}