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Published on: April 11, 2016
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Analytical Validation of Next-Generation Sequencing-Based Comprehensive Liquid Biopsy Assay for Therapy Selection
Hala Boulos1, Christine Lo1, Wei Zhu1
1Tempus AI, Inc., Chicago, Illinois.
The Journal of Molecular Diagnostics : JMD
|April 26, 2025
Summary
Tempus xF+ is a novel liquid biopsy assay for advanced solid tumors. Analytical validation shows its potential for comprehensive genomic profiling and blood tumor mutational burden calculation in oncology.
Area of Science:
- Oncology
- Genomics
- Molecular Diagnostics
Background:
- Liquid biopsies offer real-time monitoring of cancer biomarkers.
- Assessing tumor burden and recurrence is crucial in advanced solid tumors.
Purpose of the Study:
- To perform analytical validation of the Tempus xF+ liquid biopsy assay.
- To compare the xF+ assay with a smaller panel assay.
- To explore the clinical utility of the xF+ assay for comprehensive genomic profiling.
Main Methods:
- The Tempus xF+ assay was analytically validated.
- The assay detects cell-free DNA (cfDNA) in blood samples.
- It covers 523 genes, detecting single-nucleotide variants, insertions-deletions, copy number gains, and translocations.
Main Results:
- The xF+ assay demonstrated analytical validation.
- It enables the calculation of blood tumor mutational burden.
- Comparison with a smaller panel assay was performed.
Conclusions:
- The Tempus xF+ assay is a validated liquid biopsy tool for advanced solid tumors.
- Its comprehensive panel size supports detailed genomic analysis and blood tumor mutational burden assessment.
- The assay shows potential for clinical utility in oncology practice.
