CPT® Code 81520

Oncology (breast), mRNA gene expression profiling by hybrid capture of 58 genes (50 content and 8 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a recurrence risk score

The CPT® Code 81520 pertains to a specialized molecular genomic testing procedure focused on breast cancer. This test involves mRNA gene expression profiling, which is a method used to analyze the expression levels of specific genes within a tumor sample. In this case, the test evaluates a total of 58 genes, comprising 50 content genes that are indicative of the tumor's characteristics and 8 housekeeping genes that serve as controls to ensure the accuracy of the results. The tissue used for this analysis is formalin-fixed paraffin-embedded breast tumor tissue, which is a common method for preserving biological samples for histological examination.

The primary purpose of this test is to provide a prognostic indicator for recurrence-free survival, particularly in post- and peri-menopausal women diagnosed with Stage I or II breast cancer. This includes patients with lymph node-negative disease as well as those with Stage II lymph node-positive disease involving 1 to 3 nodes, and who have hormone receptor-positive breast cancer. The test results are reported as a recurrence risk score (ROR score), which is generated through a combination of the gene expression data and clinical factors such as tumor type, size, and lymph node involvement. The ROR score categorizes the risk of cancer recurrence into three levels: low, intermediate, and high, based on specific score ranges for both node-negative and node-positive patients. This information is crucial for guiding treatment decisions and patient management strategies in oncology.