NeXT Personal Dx

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NeXT Personal® DxSensitivity matters for patients with early-stage NSCLC

Stratify early stage NSCLC patients with ultra-sensitive MRD testing

Patients with undetectable circulating tumor DNA (ctDNA) by Next Personal® had longer overall survival and progression-free survival.¹
Ultra-low levels of ctDNA, under 80 Parts Per Million (PPM) were not detected with previous generation assays in Lung TRACERx cohorts.^1-4
Non-small cell lung cancer (NSCLC) patients with ctDNA detected by NeXT Personal®, including patients with ultra-low ctDNA detections, had significantly higher risk of relapse than patients with undetectable ctDNA.¹

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Review NeXT Personal® clinical performance
in a 170+ patient study¹

Up to 4X higher sensitivity*,^1-4

NeXT Personal® Dx showed up to 4X higher sensitivity for pre-operative ctDNA detection in LUAD patients compared to non-Personalis, previous generation assays.

6-month lead time over imaging¹

NeXT Personal® Dx detected ctDNA recurrence with a median lead time of 6 months compared to radiographic imaging.

94% PPV and 89% NPV¹

Strong PPV of 94%, NPV of 89% for recurrence with serial testing over a median follow-up of 5 years in early-stage NSCLC patients.

TRACERx Data Summary

Abbreviations: LUAD, lung adenocarcinoma; NSCLC, non-small cell lung cancer; NPV, negative predictive value; PPV, positive predictive value
*All assays were used to analyze patients from the TRACERx cohort, but the specific patients analyzed by each assay may differ.

ESMO 2023: Lung TRACERx data

Dr. James R. Black, MD, from UCL, London, UK and Dr. Richard Chen, MD, MS, Chief Medical Officer at Personalis discuss NeXT Personal and clinical implications based on new ESMO data. Lung TRACERx is one of the most robust prospectively collected observational ctDNA studies for early-stage non-small cell lung cancer (NSCLC) with 170+ patients in the NeXT Personal cohort collected with median 5 years of follow-up, analyzed retrospectively.

Ultra-sensitive ctDNA testing demonstrated the importance of a negative result for patients with early stage NSCLC¹

Pre-surgical baseline ctDNA detection

Ultra-sensitivity for early stage lung cancer*,^1-3

Detected up to 4X as many patients with disease as previous generation assays in a low-shedding cancer
100% baseline detection rate in non-LUAD¹

Predictive of clinical outcomes¹

Pre-surgical ctDNA status demonstrated to be highly predictive of 5-year overall survival (OS) and relapse-free survival (RFS) in NSCLC adenocarcinoma
Both high and low levels of baseline ctDNA predicted lower 5-year OS and RFS

Ultra-low, sub-80 PPM ctDNA predicted worse outcomes*,^1-3

The presence of baseline ctDNA levels below 80 PPM was predictive for both poor OS and RFS in NSCLC LUAD patients
Less sensitive assays might have missed these clinically meaningful signals

*All assays were used to analyze patients from the TRACERx cohort, but the specific patients analyzed by each assay may differ.

Post-surgical baseline ctDNA detection

Longitudinal MRD monitoring was strongly prognostic of clinical outcomes with high PPV (94%) and NPV (89%)¹
NeXT Personal® Dx demonstrated specificity of 96%, minimizing the risk of false positives while achieving ultra-high sensitivity¹
ctDNA status was predictive of 5-year relapse-free survival (RFS) and overall survival (OS)¹
6-month lead time over imaging for recurrence detection with NeXT Personal® Dx based on its ultra-high sensitivity¹

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Resources

2023 ESMO TRACERx results webinar

View Data Presentation

Patient lung cancer brochure

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TRACERx data summary

Download PDF

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NeXT Personal® Dx

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References

Black, JRM et al. An ultra-sensitive and specific ctDNA assay provides novel pre-operative disease stratification in early stage lung cancer. ESMO annual meeting. 2023
Abbosh, C., et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature 545, 446–451 (2017)
Abbosh, C. et al. Tracking early lung cancer metastatic dissemination in TRACERx using ctDNA. Nature 616, 553–562 (2023)
For evaluations across Abbosh ‘17, Abbosh ‘23, and this study, while the patients were drawn from the TRACERx cohort, the specific patients analyzed may be different, which may lead to potential differences in study results.

PRO-1152-v1

Test Disclaimer

This test is a laboratory developed test (LDT) and is performed in the CAP accredited, CLIA-certified Personalis Clinical Laboratory. The test was developed, and its performance characteristics determined by the Personalis Clinical Laboratory. It has not been cleared or approved by the United States Food and Drug Administration (FDA).

Requirements for Isolated and Extracted Samples

Clinical samples submitted in the form of isolated or extracted nucleic acids will only be accepted if the isolation of nucleic acids occurs in a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by the CAP and/or the CMS.

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