MayoComplete Targeted RNA Sequencing Panel, Next-Generation Sequencing, Tumor

Casandra

Casandra Test Code MC75195Version 1 (DRAFT)

Performing Lab

Lab Mayo Clinic LabLab Test ID MCRSPCPT Code 81456

MayoComplete Targeted RNA Sequencing Panel, Next-Generation Sequencing, Tumor

Clinical Use

Use

This test is primarily used for identifying gene fusions that aid in diagnosing solid tumors and secondarily for identifying fusions with therapeutic or prognostic significance. It evaluates 1445 genes for somatic gene fusions and specific known abnormal variants in MET, EGFR, and BCOR genes, without assessing germline alterations. Molecular analysis of biomarkers is utilized in oncology to support diagnosis, prognosis, and therapeutic management of patients.

Special Instructions

A pathology report must accompany the specimen and include essential information such as patient name, block number, tissue collection date, source of the tissue, and diagnosis or potential diagnosis. Adequate tumor nuclei percentage in the tissue sample is essential for accurate results.

Limitations

This assay is not validated for the detection of single nucleotide variations, insertions, deletions, copy number alterations, or gene expression. It primarily detects in-frame gene fusions and certain known transcript variants. Rare variants may lead to false-negative or false-positive results. The sensitivity depends on several factors, including tumor percentage and expression level. A negative result does not completely rule out the presence of fusions or variants that may be below the detection limits. It's validated on cytology slides and FFPE tissues; improper specimen handling can affect results.

Test Details

New York Approved