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NeXT Personal Dx
Clinical Genetic Test
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offered by
Personalis, Inc.
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GTR Test Accession: Help GTR000613273.1
Registered in GTR: 2024-07-10
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Last annual review date for the lab: 2024-02-15 LinkOut
At a Glance
Test purpose: Help
Drug Response; Monitoring; Predictive; ...
Conditions (1): Help
Solid tumor
Chromosomal regions/ Mitochondria (1): Help
Human genome
Methods (1): Help
Molecular Genetics - Sequence analysis of the entire coding region: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Target population: Help
Patients with solid tumor cancers
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
Personalis, Inc.
View lab's website
View lab's test page
Specimen Source: Help
  • Cell-free DNA
  • Paraffin block
  • Peripheral (whole) blood
  • Plasma
Contact Policy: Help
Laboratory can only accept contact from health care providers. Patients/families are encouraged to discuss genetic testing options with their health care provider.
How to Order: Help
Contact client services for test availability at [email protected].
Order URL
Test development: Help
Test developed by laboratory (no manufacturer test name)
Informed consent required: Help
Decline to answer
Pre-test genetic counseling required: Help
Decline to answer
Post-test genetic counseling required: Help
Decline to answer
Recommended fields not provided:
Test Order Code, Lab contact for this test, Test strategy
Conditions Help
Total conditions: 1
Condition/Phenotype Identifier
Test Targets
Chromosomal regions/Mitochondria Help
Total chromosomal regions/mitochondria: 1
Chromosomal region/Mitochondrion Associated condition
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument *
Sequence analysis of the entire coding region
Next-Generation (NGS)/Massively parallel sequencing (MPS)
* Instrument: Not provided
Clinical Information
Test purpose: Help
Drug Response; Monitoring; Predictive; Prognostic; Recurrence; Risk Assessment; Therapeutic management
Target population: Help
Patients with solid tumor cancers
Recommended fields not provided:
Clinical validity, Clinical utility, What is the protocol for interpreting a variation as a VUS?, Are family members with defined clinical status recruited to assess significance of VUS without charge?, Will the lab re-contact the ordering physician if variant interpretation changes?, Is research allowed on the sample after clinical testing is complete?, Sample negative report, Sample positive report
Technical Information
Test Comments: Help
Personalis’s NeXT Personal Dx test, performed by the Personalis CLIA/CAP Clinical Laboratory, is a personalized tumor-informed liquid biopsy assay designed to detect molecular residual disease (MRD) using circulating tumor DNA (ctDNA) from patients previously diagnosed with a solid tumor cancer. Individualized molecular profiles are established by upfront tissue and matched … View more
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
NeXT Personal Dx is analytically validated for ultra-sensitive MRD detection and cancer treatment response monitoring. In a recent validation study, analytical range measurements demonstrated a detection threshold of 1.67 parts per million (PPM) of ctDNA with a LOD95 of 3.45 PPM. Results of the study showed 100% measured analytical specificity, … View more
View citations (1)
  • Northcott J, Bartha G, Harris J, Li C, Navarro FCP, Pyke RM, Hong M, Zhang Q, Ma S, Chen TX, Lai J, Udar N, Saldivar JS, Ayash E, Anderson J, Li J, Cui T, Le T, Chow R, Velasco RJ, Mallo C, Santiago R, Bruce RC, Goodman LJ, Chen Y, Norton D, Chen RO, Lyle JM. Analytical validation of NeXT Personal®, an ultra-sensitive personalized circulating tumor DNA assay. Oncotarget. 2024;15:200-218. doi:10.18632/oncotarget.28565. Epub 2024 Mar 14. PMID: 38484152.
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Alternative Assessment

PT Provider: Help
Self

CAP Testing Information Help
Next-Generation Sequencing-Solid Tumor; Next-generation sequencing; NGSST
Recommended fields not provided:
Test Confirmation, Assay limitations, Description of internal test validation method, Description of PT method
Regulatory Approval
FDA Review: Help
Category: Not Applicable
NYS CLEP Approval: Help
Number:
Status: Pending
Additional Information
Consumer resources:

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