The Breast Cancer Index^SM test report

Performed with no pre-conceived clinical bias, the Breast Cancer Index test offers results that are objective, quantifiable, and clinically impactful. Specimens are optimally analyzed through bioTheranostics’ CLIA-certified, CAP accredited diagnostic service laboratory, which reports breast cancer recurrence risk in ER+, lymph node-negative patients in an easy-to-read format.

Assay specifics

Relative gene expression for HOXB13 and IL17BR (H/I), ER and Progesterone Receptor (PR) are evaluated in paraffin-embedded tissue sections of patient breast tumor, through extraction of RNA from the tissues, reverse transcription to cDNA, and quantitative measurement of this product using real time PCR. Four genes with stable and uniform expression in tissues are used as an internal standard against which the expression of the genes of interest is measured.

The molecular grade index (MGI) assay measures the relative expression levels of five cell cycle-regulated genes by real-time RT-PCR and combines these values into a single index. In addition, four genes (with stable and uniform expression within breast cancer tissues) are measured and used to normalize differences in sample input. The test is performed by extracting RNA from formalin-fixed paraffin-embedded tissue sections containing breast cancer cells, reverse transcribing the RNA to cDNA, and quantitative measurement of this product using real time PCR.

Reading the results

The test results will include patient value, reference range, and recurrence risk per both H/I and MGI biomarkers, as well as low, intermediate, and high risk five and ten year recurrence probabilities.