Caris Assure

Casandra

Casandra Test Code CA34257Version 1 (DRAFT)

Performing Lab

Lab Caris Life SciencesLab Test ID N/A

Clinical Use

Use

Caris Assure is a blood-based profiling test designed to provide comprehensive molecular analysis of tumor biomarkers when tumor tissue is not feasible. It employs circulating nucleic acid sequencing (cNAS) to assess DNA and RNA from plasma and genomic DNA and mRNA from circulating white blood cells. This test is critical for physicians to distinguish between somatic tumor variants, clonal hematopoiesis (CH) mutations, and incidental germline mutations, which aids in making targeted therapy decisions while avoiding off-target drugs. The inclusion of pharmacogenomics analysis, specifically the DPYD gene, helps customize chemotherapy to avoid severe toxicities. Caris Assure also delivers genomic signatures like microsatellite instability (MSI), blood tumor mutational burden (bTMB), and predicted HLA genotype, offering deeper insights for therapy selection.

Special Instructions

Caris Assure is minimally invasive and used for patients with previously diagnosed solid malignant neoplasms when tissue biopsies are not possible. RNA results are for investigational use only, and the test is not available in all locations. Specimen preparation should include completed forms with the shipper when sending samples. For complete performance specifications, review the technical information provided by the company.

Limitations

Caris Assure is not a replacement for comprehensive germline testing. Incidental pathogenic alterations are reported, including ACMG recognized cancer genes. Negative results do not imply the absence of germline mutations. RNA results from the test are intended for investigational purposes only. The assay is available in selected locations and is intended for patients with previously diagnosed solid malignant neoplasms.

Test Details

Methodology

NGS (WES)

Biomarkers

Whole Exome Sequencing that covers 23,000+ genes with an average depth of 10,000x, analyzing plasma cfDNA and cfRNA as well as gDNA and mRNA from white blood cells.

NGS • WES