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The Most Powerful
Liquid Biopsy Assay
Ever Developed

Caris AssureTM

Caris Assure is a minimally invasive blood test that provides comprehensive molecular analysis of tumor biomarkers when tumor tissue is not available. The assay utilizes circulating Nucleic Acid Sequencing (cNAS), a novel approach to liquid biopsy that analyzes cell-free DNA and RNA from plasma, plus genomic DNA and messenger RNA from circulating white blood cells (WBCs), to distinguish:
  • Somatic tumor variants – Caris Assure provides confidence in therapy decisions by distinguishing somatic tumor from CH or germline variants, helping to avoid off-target drugs.
  • Incidental CH – By sequencing both plasma and buffy coat (i.e., white blood cells), Caris Assure distinguishes clonal hematopoiesis (CH) from somatic tumor mutations.
  • Incidental germline† – Also by sequencing plasma and buffy coat, Caris Assure can distinguish germline and somatic mutations.
Caris Assure has the potential to pick up more mutations, with a sensitivity of 93.8% when compared to matched tissue collected within 30 days and using ≥5 ng of input material. Test results include genomic signatures such as microsatellite instability (MSI) and blood tumor mutational burden (bTMB), plus HLA genotyping to provide deep molecular insights to help inform therapy decisions.

SPECIMEN TYPE(S)

Whole Blood

APPLICATION

Profiling for therapy selection

DOCUMENT DOWNLOADS

Ordering Requisition

Sample Report

Caris Assure Brochure

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Every Gene for Every Patient: Whole Exome and Whole Transcriptome Sequencing from Blood

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TECHNOLOGY

Circulating Nucleic Acid

Sequencing (cNAS)

APPLICATION

Biomarker Analysis
(including resistance mutations)

BIOLOGICAL COVERAGE

Plasma: cfDNA, cfRNA

White Blood Cells: gDNA, mRNA

Variant Coverage (Pathogenic and Likely pathogenic)

Tumor-Derived

Incidental CH

Incidental Germline†

GENES & DEPTH

23,000+ 8,000x (raw average for clinically relevant genes)

Next generation sequencing

Whole Exome

Whole Transcriptome

Alterations

SNV  InDel 
CNA  Fusions

Genomic Signatures/Other

bTMB  HLA Genotype 
MSI

Sample Quantity

Two Tubes Whole Blood

Performance in Advanced/metastic Patients

Compared to matched tissue collected within 30 days; based on ≥5 ng of cNAS input. Minimum reportable allele frequency is 0.1%.

Clinically Actionable SNV and InDel:

Sensitivity 93.8%

Specificity >99.9%

PPV 96.8%

Incidental Germline† :

Sensitivity >99%

Specificity >99%

PPV >99%

†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.

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.

Clinical Confidence Through Comprehensive and Reliable Results

This revolutionary, pan-cancer assay utilizes a novel circulating Nucleic Acid Sequencing (cNAS) approach. With deep molecular insights from a minimally invasive blood sample, Caris Assure delivers uncompromising reliability and performance to guide personalized treatment decisions and help improve patient outcomes.
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Somatic Tumor

By distinguishing somatic (acquired) variants from incidental CH or incidental germline results, Caris Assure provides confidence in therapy decisions and avoidance of off-target drugs.

Incidental CH

Clonal hematopoiesis (CH) mutations from aging white blood cells may cause false positive results in blood-based assays. Caris Assure distinguishes CH from somatic tumor mutations to improve accuracy.

Incidental Germline

Caris Assure analyzes genomic DNA from circulating white blood cells found in the buffy coat and can distinguish incidental germline† mutations from somatic mutations. 

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Comprehensive Molecular Intelligence Report​

The Caris Molecular Profiling Report delivers high impact results, including potentially relevant, actionable clinical information, in an easy-to-interpret format. Every report includes access to the MI Portal and the Clinical Trials Connector™, which matches each patient’s unique biomarker expression profile to open, pertinent and clinical trial opportunities.
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Tissue Profiling

Caris tissue-based profiling, the most comprehensive and trusted molecular profiling.
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Resources

Caris' resources provide valuable information about precision oncology and advancing cancer care.
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