Introduction
Caris Assure® is blood based comprehensive molecular profiling designed for patients with previously diagnosed solid tumours when tissue biopsy is not feasible. It combines whole-exome sequencing (WES) of cell-free DNA and whole-transcriptome sequencing (WTS) of cell-free RNA from plasma, alongside analysis of genomic DNA and RNA from matched white blood cells in the buffy coat. This approach enables simultaneous detection of tumour-derived mutations and identification of non-tumour signals, improving accuracy in variant interpretation.
Caris Assure® enables detection of:
Somatic tumour mutations
Identified through analysis of cell-free DNA and RNA in plasma, reflecting tumour-derived alterations that may inform targeted therapy decisions.
Incidental germline variants
Differentiated from somatic variants by comparing mutations found in plasma to genomic DNA from matched white blood cells in the buffy coat.
Clonal haematopoiesis (CH) variants
Distinguishes somatic tumour variants from CH variants by analysing DNA and RNA from white blood cells in the buffy coat.
Caris Assure® guides oncologists with list of actionable biomarkers associated with FDA-approved therapies and clinical trials.
Technical Information
Caris Assure®* uses total nucleic acid (cfDNA and cfRNA) extracted from plasma to perform whole-exome sequencing (WES) and whole-transcriptome sequencing (WTS). The assay detects single-nucleotide variants (SNVs), insertions and deletions (indels), gene fusions, and selected copy-number alterations across over 23.000 genes, including more than 290 with known clinical relevance in cancer.
Matched sequencing of white blood cell DNA and RNA from the buffy coat enables identification of germline variants and clonal haematopoiesis (CH), helping distinguish tumour-specific alterations from background noise.
In addition to variant detection, Caris Assure® provides genome-wide molecular signatures, including:
Microsatellite instability (MSI)
Identifies patients with high MSI status eligible for immunotherapy
Blood-Based tumour mutational burden (bTMB)
Supports potential clinical trial eligibility
HLA genotyping
May inform immunotherapy response
Sample Quantity: 2 Tubes Whole Blood (10 mL PAXgene® Blood ccfDNA tubes)
Caris Assure® provides comprehensive molecular tumour profiling providing evidence-based insights into biomarker targeted therapies with potential benefit and lack of benefit, identifying therapies that may have not been considered and finding potential clinical trials suitable for patient’s tumour profile.
Assay Performance Specifications
Performance in advanced/metastatic patients compared to matched tissue collected within 30 days; based on ≥5 ng of cNAS input. Clinically actionable SNVs and indels demonstrated 93.8% sensitivity and 96.8% PPV, with >99.99% specificity. Incidental germline reported >99% for sensitivity, PPV and specificity.
*Caris Assure™ is intended for patients with previously diagnosed solid malignant neoplasms when tissue is not feasible and is to be used by qualified healthcare professionals. RNA results are intended for investigational purposes only. Not available in all locations.
**Not a replacement for comprehensive germline testing. Incidental pathogenic alterations are reported, including ACMG recognized cancer genes. Negative results do not imply the patient does not harbor a germline mutation.
Why Choose Caris Assure®?
Comprehensive Molecular Profiling
Caris Assure® performs whole-exome (WES) and whole-transcriptome (WTS) on plasma-derived cfDNA and cfRNA, profiling over 23,000 genes, including 290+ cancer-relevant targets.
False Positive Reduction
By sequencing matched plasma and buffy coat samples, Caris Assure® distinguishes somatic tumour mutations from germline and clonal haematopoiesis (CH) variants, reducing false positives and improving clinical actionability.
Personalised Treatment
The report provides evidence-based treatment options linked to identified biomarkers and matches patients to relevant clinical trials based on their tumour’s molecular profile.
Genome-wide Signatures
Includes analysis of microsatellite instability (MSI), blood-based tumour mutational burden (bTMB), and HLA genotyping, supporting immunotherapy selection and trial matching.
Applications
Therapy selection
Identifies biomarker-driven treatment options based on the patient’s tumour profile
Clinical Trial Matching
Using biomarker information to match individuals with suitable clinical studies
Tissue-limited cases
Offers a non-invasive profiling solution when tumour biopsy is unavailable
How Does Caris Assure® work?
Caris Assure® is a blood-based, comprehensive molecular profiling platform that analyses DNA and RNA from plasma and white blood cells. It uses whole exome and whole transcriptome sequencing with advanced bioinformatics to identify tumour-specific mutations, avoid false positives from clonal haematopoiesis, and flag incidental germline variants, supporting more precise, personalised treatment decisions without the need for tissue biopsy.
Research and Publications
Explore Caris Life Sciences’ latest research and clinical publications on precision oncology, molecular profiling and liquid biopsy by visiting Caris Life Sciences’ publications library.
