MI Cancer Seek®

Casandra

Casandra Test Code CA23310Version 1 (DRAFT)

Performing Lab

Lab Caris Life SciencesLab Test ID N/A

Clinical Use

Use

MI Cancer Seek is a next-generation sequencing (NGS) based in vitro diagnostic device designed for molecular profiling of solid tumors. It utilizes whole exome sequencing (WES) and whole transcriptome sequencing (WTS) to detect single nucleotide variants (SNVs), insertions and deletions (indels), microsatellite instability (MSI), tumor mutational burden (TMB), and copy number amplification (CNA) in solid tumors. The test is approved by the FDA as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies. It serves both adult and pediatric patients, offering comprehensive insights into tumor biology to guide therapy selection.

Special Instructions

MI Cancer Seek is an FDA-approved companion diagnostic, specifically intended for use with formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens. It requires a minimum of 20% tumor nuclei content and is conducted on pre-qualified Illumina NovaSeq 6000 instruments. The testing is restricted to sale by or on the order of a physician and is performed exclusively at Caris Life Sciences.

Limitations

MI Cancer Seek is not intended for germline variant detection. It requires a minimum tumor percentage of 20% for alteration detection, with enrichment recommended for lower percentages. A negative result does not exclude the possibility of mutations below the detection limit. Certain alterations such as ERBB2 CNA have low positive percent agreement, suggesting the need for confirmation with another FDA-approved test. The assay may also yield false negatives in samples with high necrotic, melanin, or fat cell content.

Test Details

FDA Approved

Companion Diagnostic

Methodology

NGS (CGP)

Biomarkers

2 components

DNA Sequencing • WESRNA Sequencing • WTS

Result Turnaround Time

14 days

Specimen

Tumor Tissue

Volume

Not provided

Minimum Volume

≥50 ng DNA

Container

Formalin-based fixatives only

Collection Instructions

Specimens should be tumor-containing formalin-fixed paraffin-embedded blocks from the most recent surgery or biopsy. Successive sections will be created from the block until sufficient material for testing orders is obtained.