MayoComplete Lung Cancer Mutations, Next-Generation Sequencing, Tumor

Clinical Use

Use

This test is useful for the diagnosis and management of patients with lung cancer. It assesses microsatellite instability and evaluates somatic mutations within several key genes, including ALK, BRAF, EGFR, ERBB2, HRAS, KRAS, MDM2, MET, NRAS, RET, ROS1, and STK11. The test helps in identifying molecular targets for targeted therapy and provides insights into the prognosis and treatment options for individuals with lung cancer. Microsatellite instability status determined by the test can be crucial for evaluating immunotherapy efficacy in solid tumors.

Special Instructions

Not provided.

Limitations

This test does not assess germline alterations within the genes listed. It identifies mutations in solid tumor samples only. The assay cannot differentiate between somatic and germline alterations. The analytical sensitivity is 5% mutant allele frequency with a minimum coverage of 500X, requiring a sample with at least 20% tumor content. It does not detect large-scale genomic copy number variants, multi-exon deletions, duplications, or epigenetic modifications. Variants of uncertain significance may be identified and diagnostic errors may result from improper specimen collection.

Test Details

New York Approved