{"entity":{"id":"next-personal","kind":"drug","name":"NeXT Personal Dx","aka":["NeXT Personal","Personalis NeXT Personal","Tempus xM (NeXT Personal Dx)"],"tldr":"Personalis' whole-genome blood test for leftover cancer, which tracks up to 1,800 of the tumour's own mutations and is Medicare-covered in breast and lung cancer.","summary":"NeXT Personal Dx is Personalis' tumour-informed residual disease test. Whole-genome sequencing of tumour and normal designs a panel of up to 1,800 variants, and Personalis states detection down to about one part per million of ctDNA with specificity above 99.9%. Medicare covered it on 7 November 2025 (effective 7 October 2025) for surveillance after stage II and III breast cancer, then in the first quarter of 2026 for surveillance in stage I-III non-small cell lung cancer, on 12 May 2026 for monitoring immunotherapy in late-stage solid tumours, and on 19 May 2026 for monitoring neoadjuvant therapy in stage II-III triple-negative or HER2-positive breast cancer. Tempus has sold the test since a partnership in November 2023, listing it as xM (NeXT Personal Dx), and on 20 July 2026 Personalis agreed to be acquired by Tempus; Personalis' shareholders are due to vote on 30 November 2026. It is a laboratory-developed test performed in Personalis' CLIA-certified laboratory and has not been cleared or approved by the FDA.","status":"established","asOf":"2026-11-03","links":[{"label":"Personalis: NeXT Personal Dx","url":"https://www.personalis.com/for-clinicians/next-personal-dx/"},{"label":"Personalis 8-K: Medicare coverage in stage II-III breast cancer (November 2025)","url":"https://www.sec.gov/Archives/edgar/data/1527753/000119312525273416/d158834d8k.htm"},{"label":"Personalis first-quarter 2026 results: Medicare coverage in stage I-III NSCLC","url":"https://www.sec.gov/Archives/edgar/data/1527753/000119312526211850/psnl-ex99_1.htm"},{"label":"Personalis 8-K: Medicare coverage for immunotherapy monitoring (12 May 2026)","url":"https://www.sec.gov/Archives/edgar/data/1527753/000119312526221574/psnl-20260512.htm"},{"label":"Personalis 8-K: Medicare coverage for neoadjuvant monitoring in breast cancer (19 May 2026)","url":"https://www.sec.gov/Archives/edgar/data/1527753/000119312526232533/psnl-20260519.htm"},{"label":"Personalis: agreement to be acquired by Tempus AI (20 July 2026)","url":"https://www.sec.gov/Archives/edgar/data/1527753/000119312526308488/d68794dex991.htm"},{"label":"Northcott et al., analytical validation of NeXT Personal (Oncotarget 2024)","url":"https://doi.org/10.18632/oncotarget.28565"},{"label":"CMS MolDX billing article A58376: minimal residual disease testing for solid tumour cancers","url":"https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=58376"}],"tags":["test"],"related":["signatera","radar-mrd","precise-mrd"],"cancers":["breast-cancer","tnbc","breast-her2-positive","nsclc"],"sections":[],"technologies":["mrd-testing","liquid-biopsy","wes-wgs"],"targets":[],"drugs":[],"companies":["personalis","tempus"],"institutions":[],"pathways":[],"terms":["mrd","ctdna","tumour-informed-assay"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["What a result means: detectable tumour DNA after treatment predicts relapse; a very sensitive test finds smaller amounts, but whether acting on that earlier signal improves survival is still being tested.","Not confirmed: the exact date of the lung cancer coverage (Personalis reports it only as received in the first quarter of 2026), the launch date, and any FDA Breakthrough Device designation."],"brand":"NeXT Personal Dx","modality":"Tumour-informed whole-genome ctDNA minimal residual disease test (up to 1,800 variants)","mechanism":"Whole-genome sequencing of the tumour and a matched normal blood sample builds a personalised signature of up to 1,800 variants, which is then tracked in plasma at sequencing depths of up to about 100,000-fold.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[{"country":"US","reimbursement":"Medicare (MolDX) covers post-treatment surveillance in stage II-III breast cancer (decision 7 November 2025, effective 7 October 2025), surveillance in stage I-III non-small cell lung cancer (first quarter of 2026), and monitoring of neoadjuvant therapy in stage II-III triple-negative or HER2-positive breast cancer (19 May 2026)","source":"https://www.sec.gov/Archives/edgar/data/1527753/000119312526232533/psnl-20260519.htm","asOf":"2026-11-03"}],"regulatoryEvents":[]},"route":"/drugs/next-personal/","neighbours":{"drug":[{"id":"foundationone-mrd","kind":"drug","name":"FoundationOne MRD","route":"/drugs/foundationone-mrd/"},{"id":"precise-mrd","kind":"drug","name":"Precise MRD","route":"/drugs/precise-mrd/"},{"id":"radar-mrd","kind":"drug","name":"RaDaR ST","route":"/drugs/radar-mrd/"},{"id":"signatera","kind":"drug","name":"Signatera","route":"/drugs/signatera/"},{"id":"tempus-xm-mrd","kind":"drug","name":"Tempus xM for MRD (tumour-naive)","route":"/drugs/tempus-xm-mrd/"}],"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"},{"id":"breast-her2-positive","kind":"cancer","name":"HER2-positive breast cancer","route":"/cancers/breast-her2-positive/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"technology":[{"id":"liquid-biopsy","kind":"technology","name":"Liquid biopsy (ctDNA)","route":"/technologies/liquid-biopsy/"},{"id":"mrd-testing","kind":"technology","name":"MRD / molecular residual disease testing","route":"/technologies/mrd-testing/"},{"id":"wes-wgs","kind":"technology","name":"Whole-exome & whole-genome sequencing","route":"/technologies/wes-wgs/"}],"company":[{"id":"personalis","kind":"company","name":"Personalis (Tempus)","route":"/companies/personalis/"},{"id":"tempus","kind":"company","name":"Tempus AI","route":"/companies/tempus/"}],"term":[{"id":"ctdna","kind":"term","name":"Circulating tumour DNA (ctDNA)","route":"/terms/ctdna/"},{"id":"mrd","kind":"term","name":"Minimal / molecular residual disease (MRD)","route":"/terms/mrd/"},{"id":"tumour-informed-assay","kind":"term","name":"Tumour-informed versus tumour-naive ctDNA assays","route":"/terms/tumour-informed-assay/"}],"roadmap":[{"id":"ctdna-tests","kind":"roadmap","name":"ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment","route":"/roadmaps/ctdna-tests/"},{"id":"diagnostics-roadmap","kind":"roadmap","name":"Diagnostics roadmap: stains → gene panels → blood tests that decide treatment","route":"/roadmaps/diagnostics-roadmap/"}],"biomarker":[{"id":"ctdna-mrd-positive","kind":"biomarker","name":"ctDNA MRD positivity (molecular residual disease after curative treatment)","route":"/biomarkers/ctdna-mrd-positive/"}]}}