Caris Assure Blood-Based Profiling


The Most Powerful Liquid Biopsy Assay Ever Developed

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Be Sure with Caris Assure

With deep molecular insights from a simple blood sample, Caris Assure™ offers a minimally-invasive liquid biopsy option for biomarker analysis of cancer patients when tissue samples are not available. No matter the specimen type – tissue or blood – Caris Life Sciences’ flexible, multi-faceted molecular profiling platforms deliver uncompromising reliability and performance to guide personalized treatment decisions and help improve patient outcomes.*

The Most Powerful Liquid Biopsy Assay Ever Developed.


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 Germline†    Incidental CHIP


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/Metastatic Patients
Compared to matched tissue collected within 30 days; based on ≥5 ng of cNAS input.
Clinically Actionable SNV and INDEL:
Sensitivity 93.8%
Specificity >99%
PPV 96.8%
LOD 0.1% VAF
Incidental Germline :
Sensitivity >99%
Specificity >99%
PPV >99%

Tumor-Derived, Incidental Germline† and Incidental CHIP Detection in a Single Assay

Caris molecular profiling leverages a multi-faceted approach to personalized cancer treatment. By identifying tumor-derived somatic variants, plus incidental germline† and incidental CHIP variants, Caris Assure provides clinicians with the comprehensive molecular intelligence needed to develop treatment plans that may help improve patient outcomes.

Tumor-Derived Somatic Testing

Somatic (acquired) variants are genetic alterations that are not present in egg or sperm cells but occur after conception, and therefore cannot be inherited by following generations. Somatic variants are classified by the level of clinical actionability in the Caris Assure report and can be tumor-specific.

Incidental Germline Characterization

Germline (hereditary) variants are genetic alterations that are present in egg or sperm cells. Such variants will be present in every cell of the body when inherited by offspring. Recognizing germline mutations in predisposed individuals can assist in risk reduction and cancer prevention. Caris Assure analyzes genomic DNA from circulating white blood cells and can distinguish incidental germline‡ mutations from somatic mutations.

Incidental CHIP Analysis

Clonal hematopoiesis of indeterminate potential (CHIP) mutations are common age-related somatic mutations that accumulate in the cells of blood or bone marrow. CHIP mutations create biological “noise” that may cause false positive results. Caris Assure distinguishes somatic CHIP mutations from somatic tumor mutations to reduce false positives and improve specificity.

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*Caris Assure™ is intended for patients with previously diagnosed solid malignant neoplasms when tissue is infeasible 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 detected in ACMG recognized cancer genes are reported. Negative results do not imply the patient does not harbor a germline mutation.

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