CPT® Code 81519

Oncology (breast), mRNA, gene expression profiling by real-time RT-PCR of 21 genes, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as recurrence score

The CPT® Code 81519 refers to a specialized laboratory test utilized in oncology, specifically for breast cancer. This test involves the analysis of messenger RNA (mRNA) gene expression profiling through real-time reverse transcriptase polymerase chain reaction (RT-PCR) of a total of 21 genes. The tissue sample used for this analysis is formalin-fixed paraffin-embedded tissue obtained from breast tumor(s). The primary aim of this test is to provide a recurrence score that assists healthcare providers in making informed decisions regarding chemotherapy treatment planning. The 21 genes analyzed include 16 cancer-related genes, such as Ki-67, STK 15, SURVIVIN, and HER2, among others, as well as 5 reference genes, including BETA-ACTIN and GAPDH. This comprehensive gene expression profiling is performed in conjunction with standardized tests for estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) status on the tumor tissue. The results of this test yield an algorithmically derived recurrence score, which is particularly relevant for patients with grade 1 or 2, unilateral, non-fixed tumors that are greater than 0.5 cm in size, ER positive or PR positive, HER2 negative, and without lymph node involvement. This score provides a quantitative analysis of the 10-year risk of distant disease recurrence, thereby aiding in the assessment of the potential benefits of adjuvant chemotherapy for the patient.