NEW: RNA-BASED FUSION DETECTION
Caris Assure
A New Standard in Liquid Biopsy
Caris Assure combines whole exome and whole transcriptome sequencing with matched white blood cell analysis to deliver a more complete, interpretable molecular picture for therapy selection.
Expect More from Your Liquid Biopsy:
Whole Exome Sequencing (WES)
Whole Transcriptome Sequencing (WTS)
Whole Blood Analysis (Plasma + WBCs)
Tiered Molecular Depth
Expanded DPYD (Tier 1/2) and UGT1A1 insights inform personalized dosing
7-day turnaround time (TAT) supports timely decisions
*Median TAT from sample receipt to report
Insurance coverage and financial assistance programs, 95% of patients have $0 out-of-pocket costs
3,100+ Locations
Integrated via EHR ordering
What it is:
A purpose-built blood profiling test that combines whole exome and whole transcriptome sequencing with matched white blood cell analysis to identify actionable tumor alterations and RNA-based fusions, while clarifying variant origin for accurate therapy selection.
WATCH THE VIDEO
Caris Assure | Joseph Murray, MD, PhD
By combining enhanced Whole Exome Sequencing, Whole Transcriptome Sequencing and whole-blood analysis into a single integrated platform, we are providing physicians with deeper biological insights that can help inform therapy selection and patient management.
Dr. Joe Murray, Senior Medical Director of Thoracic Oncology at Caris Life Sciences explains what sets the enhanced Caris Assure apart.
WHY IT MATTERS
One Blood Draw.
A More Complete Molecular Picture.
Whole Exome Sequencing
Confident variant detection
A 23,000+ gene WES backbone with tiered depth up to 40,000x and 96.9% sensitivity for drug-rule variants – breadth and depth, without trading one for the other.1
Whole Transcriptome Sequencing
RNA-BASED fusion detection
Complementary ctDNA and ctRNA testing identified 56% more fusion findings than ctDNA alone in internal validation.1
Whole Blood Analysis
Accurate molecular interpretation
Analyzing plasma alongside matched white blood cells distinguishes true tumor signals from non-tumor variants – reducing false positives and off-target therapy.
Select Your Region
Product availability and information may vary by location. Select your region to view the products and resources available in your area.
Not available in all locations.
Caris Assure
Designed for patients with solid tumors
When to consider
Caris Assure:
Advanced Disease or Progression
For recurrent, advanced, or metastatic solid tumors
At Key Clinical Inflection Points
When disease progression or emerging resistance prompts a treatment reassessment
When Tissue is Limited or Time-Sensitive
When tissue is insufficient, unavailable or timely molecular insight is needed to inform therapy selection
Comprehensive molecular insight from a single blood draw
Delivers a complete, evidence-based molecular profile without the need for invasive tissue biopsy
RNA-Based Fusion Detection
Complementary ctDNA + ctRNA testing reveals 56% more fusion findings than ctDNA alone. Surfacing therapy opportunities DNA-only assays may miss.1
Trusted molecular interpretation through Whole Blood Analysis
Analyzes plasma and matched white blood cells to distinguish tumor-derived alterations from incidental germline findings2 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.
Expanded pharmacogenomic insights for patient safety
Coverage includes DPYD (Tier 1/2) and UGT1A1 variants, adding treatment-relevant information to guide safer therapy selection and dosing, reducing risk of severe, potentially life-threatening treatment toxicity.
Clinical trial matching
Identifies relevant clinical trial options based on a patient’s molecular profile based on their unique molecular profile.
RNA-based fusion detection
Going Beyond DNA to Address a Critical Blind Spot in Liquid Biopsy
Caris Assure pairs ctDNA with dedicated whole transcriptome sequencing to reveal additional RNA-based fusions from a single blood draw.
DNA-based liquid biopsy relies on capturing genomic breakpoints, which may occur in large or repetitive intronic regions that are difficult to sequence. If the breakpoint is not captured, an actionable fusion may be missed.
In one published study, ctDNA testing detected 16.7% of tissue-confirmed fusions.†
Caris Assure pairs ctDNA with dedicated whole transcriptome sequencing (ctRNA) to interrogate expressed fusion transcripts, helping identify clinically actionable fusions that ctDNA alone may miss.
Combined pathogenic and likely pathogenic fusion yield
ctDNA-only: 29
ctDNA & ctRNA: 3
ctRNA-only: +18
ctDNA-only: 29
3
ctRNA-only: +18
|
ctDNA & ctRNA
56% incremental yield compared to DNA alone1
of tissue-confirmed fusions detected by ctDNA testing alone3
additional fusions detected with ctRNA1
incremental ROS1 fusion yield in NSCLC vs ctDNA alone1
TESTING WORKFLOW
How Caris Assure Works
A purpose-built assay – dedicated DNA and RNA workflows, optimized independently, then integrated with matched white blood cell sequencing into one report.
Blood Sample Collected
A simple blood draw is performed using methods to optimize specimen volume and preserve scarce, unstable cell-free RNA for sequencing.
Three Complementary Sequencing Pathways
Whole Exome Sequencing (ctDNA)
23,000+ gene therapy-focused depth up to 40,000x, and 96.9% sensitivity for drug-rule variants.1
Whole Transcriptome Sequencing (ctRNA)
Complementary RNA-based fusion detection delivers 56% more fusion findings than ctDNA alone.1
Whole Blood Analysis (Matched WBCs)
Clarifies whether findings are tumor-derived, CH-related, or germline, supporting accurate interpretation.
One Integrated Clinical Report
Brings actionable findings, trusted interpretation, and additional clinical insights together to support therapy selection.
A more complete molecular picture from a single blood draw.
WATCH THE VIDEO
Introducing Enhanced Caris Assure
A new standard in liquid biopsy, purpose-built to see what DNA-only and plasma-only approaches may miss. See the complete molecular picture. Expect more from your liquid biopsy.
WATCH THE VIDEO
Introducing Enhanced Caris Assure
A new standard in liquid biopsy, purpose-built to see what DNA-only and plasma-only approaches may miss. See the complete molecular picture. Expect more from your liquid biopsy.
Test results
Complete Molecular Intelligence Report
Caris Assure brings actionable findings, trusted interpretation, and additional clinical insights together in one treatment-focused molecular picture.
Caris Assure identifies actionable targets—including tumor alterations, RNA- and DNA-based fusions, and resistance mutations—then adds interpretive context through incidental germline and clonal hematopoiesis findings.
It completes the molecular picture with additional clinical insights, including expanded DPYD and UGT1A1 pharmacogenomics, bTMB, MSI, and predicted HLA genotype.
INTEGRATED MOLECULAR ANALYSIS
Comprehensive profiling from a single blood draw
RNA-Based Fusion Detection
Built to See What DNA-Only Approaches May Miss
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
Pharmacogenomics
Predicts the risk of severe and potentially life-threatening drug toxicity including expanded DPYD (Tier 1/2) and UGT1A1
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
Three 10mL tubes
Alterations
- SNV
- InDels
- CNA
- DNA Rearrangements
- RNA Fusions
Variant Coverage
- Somatic Tumor
- Incidental CH
- Incidental Germline2
Genomic Signatures
- MSI
- bTMB
- HLA Genotype
- DPYD (Tier 1+2) Variants
- UGT1A1 Variants
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.
1. Caris Assure internal validation data
2. 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. Not available in all locations.
3. Hasegawa N. et al. Highly sensitive fusion detection using plasma cell-free RNA in non-small-cell lung cancers. Cancer Sci. 2021 Oct;112(10):4393-4403.
Next Steps
Caris Assure