# NeXT Personal Dx

Source: https://onco.cc/drugs/next-personal/  
OnCo record `next-personal` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Test
- Status: established
- Last checked: 2026-11-03
- Also known as: NeXT Personal; Personalis NeXT Personal; Tempus xM (NeXT Personal Dx)
- Tags: test
- 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.

## 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.

## Sources

- Personalis: NeXT Personal Dx: https://www.personalis.com/for-clinicians/next-personal-dx/
- Personalis 8-K: Medicare coverage in stage II-III breast cancer (November 2025): https://www.sec.gov/Archives/edgar/data/1527753/000119312525273416/d158834d8k.htm
- Personalis first-quarter 2026 results: Medicare coverage in stage I-III NSCLC: https://www.sec.gov/Archives/edgar/data/1527753/000119312526211850/psnl-ex99_1.htm
- Personalis 8-K: Medicare coverage for immunotherapy monitoring (12 May 2026): https://www.sec.gov/Archives/edgar/data/1527753/000119312526221574/psnl-20260512.htm
- Personalis 8-K: Medicare coverage for neoadjuvant monitoring in breast cancer (19 May 2026): https://www.sec.gov/Archives/edgar/data/1527753/000119312526232533/psnl-20260519.htm
- Personalis: agreement to be acquired by Tempus AI (20 July 2026): https://www.sec.gov/Archives/edgar/data/1527753/000119312526308488/d68794dex991.htm
- Northcott et al., analytical validation of NeXT Personal (Oncotarget 2024): https://doi.org/10.18632/oncotarget.28565
- CMS MolDX billing article A58376: minimal residual disease testing for solid tumour cancers: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=58376

## Connected records

- drugs: [FoundationOne MRD](https://onco.cc/drugs/foundationone-mrd/), [Precise MRD](https://onco.cc/drugs/precise-mrd/), [RaDaR ST](https://onco.cc/drugs/radar-mrd/), [Signatera](https://onco.cc/drugs/signatera/), [Tempus xM for MRD (tumour-naive)](https://onco.cc/drugs/tempus-xm-mrd/)
- cancers: [Breast cancer (all types)](https://onco.cc/cancers/breast-cancer/), [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Liquid biopsy (ctDNA)](https://onco.cc/technologies/liquid-biopsy/), [MRD / molecular residual disease testing](https://onco.cc/technologies/mrd-testing/), [Whole-exome & whole-genome sequencing](https://onco.cc/technologies/wes-wgs/)
- companies: [Personalis (Tempus)](https://onco.cc/companies/personalis/), [Tempus AI](https://onco.cc/companies/tempus/)
- terms: [Circulating tumour DNA (ctDNA)](https://onco.cc/terms/ctdna/), [Minimal / molecular residual disease (MRD)](https://onco.cc/terms/mrd/), [Tumour-informed versus tumour-naive ctDNA assays](https://onco.cc/terms/tumour-informed-assay/)
- roadmaps: [ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment](https://onco.cc/roadmaps/ctdna-tests/), [Diagnostics roadmap: stains → gene panels → blood tests that decide treatment](https://onco.cc/roadmaps/diagnostics-roadmap/)
- biomarkers: [ctDNA MRD positivity (molecular residual disease after curative treatment)](https://onco.cc/biomarkers/ctdna-mrd-positive/)

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