Caris Assure
Next-Generation Liquid Biopsy Designed to Overcome Limitations of Plasma-Only Tests, Supporting Accurate Biomarker-Guided Therapy Selection
6-9 days
Average results turnaround upon specimen receipt
23,000+ genes
Simultaneously analyzed using Whole Exome Sequencing (WES) + Whole Transcriptome Sequencing (WTS)
93.8% Sensitivity | 99.9% Specificity
Confidently detect and distinguish variants
Somatic Tumor | Clonal Hematopoiesis | Incidental Germline†
Identify the variant source for accurate therapy selection
3,100+ Locations
Integrated via EHR ordering
What it is:
A whole blood profiling test that detects what other assays cannot to reduce false positives, avoid off-target drugs and improve patient outcomes.
Why it matters:
Leveraging its novel sequencing approach using whole blood — analyzing plasma alongside matched white blood cells — Caris Assure® helps distinguish true tumor signals from non-tumor variants, providing a clearer, more complete molecular picture to guide confident treatment decisions.
Not available in all locations.
Caris Assure
Designed for patients with solid tumor cancers
When to consider
Caris Assure:
Patients with Advanced Disease or Progression
Recurrent, late-stage or metastatic cancer
At Key Clinical Inflection Points
When treatment decisions need to be reassessed due to disease progression or emerging resistance
Tissue is Limited or Time is of Essence
Tissue for molecular profiling is insufficient or unavailable, or when rapid molecular insights are needed to guide therapy
Comprehensive molecular insight from a single blood draw
Delivers a complete, evidence-based molecular profile without the need for invasive tissue biopsy
Improved accuracy through whole blood sequencing
Analyzes plasma and matched white blood cells to distinguish tumor-derived alterations from incidental germline findings† and clonal hematopoiesis (CH)
Greater confidence in therapy selection
Helps reduce false positives that may lead to inappropriate or off-target treatment decisions
Expanded detection of actionable biomarkers
Identifies more clinically relevant alterations, including potentially targetable resistance mutations
Emerging therapies
Surfaces targeted therapies and immunotherapy options that may not have been previously considered
Built-in pharmacogenomic insights (including DPYD) for patient safety
Detects inherited variants to help guide safer therapy selection and dosing, reducing risk of severe, potentially life-threatening treatment toxicity
Clinical trial matching
Connects patients to relevant clinical trials based on their unique molecular profile
TESTING WORKFLOW
How Caris Assure Works
Caris Assure whole blood sequencing delivers accurate, actionable molecular insights from a single blood draw.
Blood Sample Collected
A simple blood draw is performed — no invasive tissue biopsy required.
Whole Blood Sequencing Performed
DNA and RNA are analyzed from both plasma and matched white blood cells using comprehensive sequencing.
Tumor-Specific Alterations Identified
Advanced direct measurement and analysis distinguishes tumor-derived alterations from incidental germline findings† and clonal hematopoiesis (CH), while also detecting inherited variants, including pharmacogenomic markers such as DPYD.
Actionable Clinical Report Delivered
Results are provided in a clear, clinically actionable report — including therapy guidance and safety insights to help inform personalized treatment decisions.
Test results
Complete Molecular Intelligence Report
The Caris Molecular Profiling Report delivers high-impact results — including relevant, potentially actionable clinical information — in an easy-to-interpret format. Every report includes access to Caris+®Portal and the Clinical Trials Connector, which matches each patient’s unique biomarker expression profile to applicable open clinical trial opportunities.
INTEGRATED MOLECULAR ANALYSIS
Comprehensive profiling from a single blood draw
Tumor Associated Findings
Delivers highly sensitive detection of genomic alterations, resulting in fewer missed alterations
Incidental Germline Findings†
Detects germline alterations that might otherwise be overlooked, enabling the right targeted therapy
Incidental CH Findings
Detects alterations that are real, minimizing false positives and avoiding off-target drugs
Genomic Signatures (bTMB and MSI)
Leverage broad WES coverage to identify immunotherapy biomarkers and deliver bTMB results highly concordant with tissue TMB
Predicted HLA Genotype
Provides results to direct patients toward clinical trial options
TRACK Table
Tracks disease progression to identify resistance mutations and new therapeutic options
DPYD Pharmacogenomics
Predicts the risk of severe and potentially life-threatening drug toxicity
AFFORDABILITY
Financial Flexibility for Patients
At Caris, we believe cancer diagnostic testing should be accessible to everyone. Our team is ready to support you with any insurance or billing questions.
Many patients don’t realize
- If you are uninsured or worried about cost, we offer financial assistance programs to help eligible patients get the testing they need without added stress.
- Caris maintains in-network coverage with most major commercial payers nationwide, including national coverage through Medicare and Medicare Advantage. Qualifying Medicare/Medicaid patients have no out-of-pocket responsibility.
- Most patients will be responsible for less than $100 USD out-of-pocket, including co-pays, co-insurance and deductibles. If your invoice is $100 USD or more, Caris will call you to discuss financial assistance options.
Publication Highlight
False Positives From Non-Tumor Variants Are a Key Challenge for First-Generation, Plasma-Only Assays: 42.3% of patients have non-tumor mutations in reportable clinical genes, including BRCA1, BRCA2, ATM, and CHEK2
Specimen Requirements
Sample and Laboratory Specifications
Specimen Type
Whole Blood
Minimum Input
Two 10mL tubes
Alterations
- SNV
- InDels
- CNA
- Fusion/Rearrangement
Variant Coverage
- Somatic Tumor
- Incidental CH
- Incidental Germline†
Genomic Signatures
- MSI
- bTMB
- HLA Genotype
- DPYD Genotype
Document Downloads
- Ordering Requisition
- Sample Report
- Caris Assure Brochure
- CH Paper Summary
- Technical Information
- How to Order
Email the completed form(s) to CustomerSupport@CarisLS.com, or fax to 1.866.479.4925. When specimen is being prepared for shipment, please include completed forms with the shipper. 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. 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.
Next Steps
Caris Assure
