Researchers compare diagnostics that predict breast cancer recurrence

Researchers at Massachusetts General Hospital reported data from a prospective comparative study showing that only Breast Cancer Index (BCI) from the bioTheranostics Inc. subsidiary of bioMerieux S.A. (Euronext:BIM) predicts risk for both early (0-5 years) and late (5-10 years) recurrence in postmenopausal women with estrogen receptor-positive lymph node-negative breast cancer. The study compared the predictive ability of BCI to the OncoType DX breast cancer assay from Genomic Health Inc. (NASDAQ:GHDX) and an IHC4 IHC test. All three tests were significantly predictive of early recurrence (p<0.0001 for all), but only BCI was significantly predictive of late recurrence (p=0.0048 compared to p=0.47 for OncoType DX and p=0.2 for IHC4). The study used archived tumor samples from breast cancer patients who were enrolled in a Phase III trial for a drug from AstraZeneca plc (LSE:AZN; NYSE:AZN) and for whom OncoType DX scores and IHC4 values had already been derived. Data were published in The Lancet Oncology.

bioTheranostics markets BCI to quantify the risk of recurrence of estrogen receptor-positive, lymph node-negative breast cancer. The assay combines the company's Theros H/I, which measures the expression of two genes that have been correlated as biomarkers that predict recurrence, and Theros Molecular Grade Index (MGI), a five-gene expression index that stratifies patients based on an assessment of molecular tumor grade and tumor proliferation rate. Genomic Health markets the Oncotype DX breast cancer assay, which analyzes the expression of 21 genes to quantify the magnitude of chemotherapy benefit and the likelihood of recurrence in early stage breast cancer patients as well as the likelihood of recurrence in pre-invasive ductal carcinoma in situ of the breast (DCIS). ...