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Biotheranostics' Breast Cancer Index Included in Latest NCCN Guidelines

NEW YORK – The latest version of the National Comprehensive Cancer Network's breast cancer clinical practice guidelines has included Biotheranostics' gene expression assay Breast Cancer Index as a tool for predicting whether patients will benefit from extended, adjuvant endocrine therapy. 

"Clinical guideline endorsement by the NCCN Panel marks an evidentiary milestone for the Breast Cancer Index underscoring its distinct clinical utility for women with hormone receptor-positive, early-stage breast cancer, and a new paradigm for the use of genomic assays to aid in endocrine decision-making," Biotheranostics CSO Catherine Schnabel said in a statement. "With NCCN Guidelines as the recognized benchmark for cancer policy, the positive recommendation of BCI as a predictive biomarker of extended endocrine benefit will allow increased patient access to this important genomic tool."

The updated guidelines note that patients who are deemed BCI-low are at lower risk of distant recurrence compared to those deemed BCI-high and do not appear to derive disease-free survival or overall survival benefit with extended endocrine therapy. However, the NCCN noted that in several studies BCI-high patients had "significant improvements" in disease-free survival with extended adjuvant endocrine therapy compared to the control arm.

Biotheranostics, which is being acquired by Hologic, said in a statement that the NCCN guidelines recognize BCI's predictive utility in this regard in both node-positive and node-negative breast cancer patients treated with tamoxifen and aromatase inhibitors. The company added that in studies BCI has demonstrated the ability to predict extended endocrine therapy benefit among patients treated with ten years of tamoxifen, five years of tamoxifen and another five years with an aromatase inhibitor, and 10 years of aromatase inhibitors.