Quantcast

Industry news that matters to you.  Learn more

bioTheranostics Awarded Medicare Coverage for Breast Cancer Index Molecular Test

bioTheranostics, Inc., a leader in molecular diagnostics for cancer, recently announced that its Breast Cancer Index test has been awarded Medicare coverage. The Centers for Medicare and Medicaid Services posted a positive coverage and reimbursement policy after evaluation by Palmetto GBA, the Medicare administrator responsible for the MolDx molecular diagnostic technology assessment program.

Gene-expression-based Biomarker Predicts Long-term Risk of Breast Cancer Recurrence

A comparison of three methods of predicting the risk of recurrence in women treated for estrogen-receptor (ER)-positive breast cancer finds that only the breast cancer index (BCI) – a biomarker based on the expression levels of seven tumor-specific genes – accurately identifies patients who continue to be at risk after five years of treatment with either tamoxifen or the aromatase inhibitor anastrozole. The study comparing the BCI with two other prognostic tests has been published online in Lancet Oncology.

bioTheranostics’ Breast Cancer IndexSM Molecular Test Identifies Risk for Early and Late Breast Cancer Recurrence, Lancet Oncology Study Finds

A study published online in The Lancet Oncology found that in a comparison of three methods of predicting the risk of recurrence of estrogen-receptor (ER)-positive breast cancer, only the Breast Cancer IndexSM (BCI) from bioTheranostics predicts risk for both early (0-5 years) and late (5-10 years) recurrence. The study provides important new information to guide patient treatment decisions at diagnosis and after several years of therapy.

Studies Show bioTheranostics’ Breast Cancer Index Identifies Breast Cancer Patients at Risk for Early and Late Recurrence, and Predicts Benefit from Extended Endocrine Therapy

bioTheranostics, developer of innovative molecular diagnostics, reported results from two new studies evaluating the performance of its Breast Cancer Index (BCI) biomarker assay in estrogen-receptor positive (ER+), early stage breast cancer. Study results showed that BCI predicts which women with early stage ER+ breast cancer are at risk for early and late distant recurrence, and which are most likely to benefit from continuing treatment with endocrine therapy after completing five years of tamoxifen.

BCI is a combinatorial biomarker with a novel mechanism of action composed of Molecular Grade Index (MGI) and the two-gene expression ratio HOXB13/IL17BR (H/I).

In a study published online in the Journal of the National Cancer Institute, tumor samples from 83 patients with breast cancer recurrence were matched to 166 patients without disease recurrence from the MA.17 trial, a landmark randomized clinical study that demonstrated improved disease-free survival with extended letrozole therapy in postmenopausal patients with ER+ breast cancer who were recurrence-free following an initial five years of tamoxifen therapy. In patients receiving extended endocrine therapy, a high H/I gene expression ratio, as measured by the BCI assay, remained significantly associated with benefit from extended endocrine therapy (p=0.0061), representing a 16.5 percent reduction in the risk of recurrence with extended letrozole treatment compared with placebo. Patients with low H/I did not benefit from extended letrozole treatment. The study authors concluded that the BCI assay identifies a subgroup of breast cancer patients disease-free after five years of tamoxifen therapy who are at risk for late recurrence, and that high H/I predicts benefit from extended endocrine therapy. The study was conducted by researchers from leading institutions, including Massachusetts General Hospital.

A second study, published online in the journal Clinical Cancer Research, examined the ability of the BCI test to predict early (0-5 years) and late (>5 years) distant recurrence in ER+, lymph node-negative breast cancer patients. The study was a retrospective analysis of tumor samples from tamoxifen-treated patients from the randomized, prospective Stockholm trial (n=317) and a multi-institutional cohort from two academic medical centers (n=358). Within the Stockholm trial cohort, BCI stratified the majority (~65 percent) of patients as low risk, with <3 percent distant recurrence rate for 0-5 years and 5-10 years. In the multi-institutional cohort, which had larger tumors, 55 percent of patients were classified by BCI as low risk, with a <5 percent distant recurrence rate for 0-5 and 5-10 years. For both groups, the BCI assay was the most significant prognostic factor beyond standard clinicopathological factors for 0-5 and >5 years. The authors concluded that the ability of the BCI test to assess risk of both early and late distant recurrence has clinical utility for decisions of chemotherapy at diagnosis and for decisions about extended endocrine therapy beyond five years.

Richard Ding, president and CEO of bioTheranostics, said there is a growing need for novel biomarkers in ER+ early stage breast cancer that guide disease management beyond the initial 5-year window. “Breast Cancer Index is the only biomarker test that has been shown in prospective trials to predict the benefit of extended endocrine therapy,” Ding said. “The results of these key studies illustrate the importance of the BCI test in identifying which patients are at risk for early and late breast cancer recurrence, and who among them will benefit from extended endocrine therapy, which is of significant clinical value. This critical information should allow many women to avoid unnecessary treatment and for the clinical focus to be on those in most need of therapy.”

Study: Prediction of Late Disease Recurrence and Extended Adjuvant Letrozole Benefit by the HOXB13/IL17BR Biomarker

Study: Breast Cancer Index Identifies Early-Stage Estrogen Receptor–Positive Breast Cancer Patients at Risk for Early- and Late-Distant Recurrence

Source: Business Wire

Biomarker Predicts Risk of Breast Cancer Recurrence After Tamoxifen Treatment

A biomarker reflecting expression levels of two genes in tumor tissue may be able to predict which women treated for estrogen-receptor (ER)-positive breast cancer should receive a second estrogen-blocking medication after completing tamoxifen treatment. In their report being published online in the Journal of the National Cancer Institute, Massachusetts General Hospital (MGH) Cancer Center investigators describe finding that the HOXB13/IL17BR ratio can indicate which women are at risk for cancer recurrence after tamoxifen and which are most likely to benefit from continuing treatment with the aromatase inhibitor letrozole (Femara).

“Most patients with early-stage, ER-positive breast cancer remain cancer-free after five years of tamoxifen treatment, but they remain at risk of recurrence for 15 years or longer after their initial treatment,” says Dennis Sgroi, MD, of the MGH Cancer Center and Department of Pathology, lead and corresponding author of the report. “Our biomarker identifies the subgroup of patients who continue to be at risk of recurrence after tamoxifen treatment and who will benefit from extended therapy with letrozole, which should allow many women to avoid unnecessary extended treatment.”

Previous research by Sgroi’s team, in collaboration with investigators from bioTheranostics Inc., discovered that the ratio between levels of expression of two genes – HOXB13 and IL17BR – in tumor tissue predicted the risk of recurrence of ER-positive, lymph-node-negative breast cancer, whether or not the patient was treated with tamoxifen. The current study of patients from MA.17, the highly successful clinical trial of letrozole, was designed to evaluate the usefulness of the HOXB13/IL17BR ratio for both prognosis – predicting which tamoxifen-treated remained patients at risk of recurrence – and for identifying who could benefit from continued treatment with letrozole.

To answer those questions the investigators analyzed primary tumor samples and patient data from the placebo-controlled MA.17 trial, which confirmed the ability of extended letrozole therapy to improve survival after the completion of tamoxifen treatment. Tissue samples were available from 83 patients whose tumors recurred during the study period – 31 who had received letrozole and 52 in the placebo group – and 166 patients with no recurrence, 91 of whom had received letrozole, with 75 getting the placebo. Analysis of the tumor samples revealed that a high HOXB13/IL17BR ratio – meaning the expression level of HOXB13 is greater than that of IL17BR – predicts an increased risk for tumor recurrence after tamoxifen therapy, but that elevated risk drops significantly if a patient receives letrozole

Paul E. Goss, MD, PhD, director of the Breast Cancer Research Program at the MGH Cancer Center and a co-author of the report, explains, “This discovery means that about 60 percent of women with the most common kind of breast cancer can be spared unnecessary treatment with the concommitant side effects and costs. But more importantly, the 40 percent of patients who are at risk of recurrence can now be identified as needing continued therapy with letrozole, and many will be spared death from breast cancer.” He and Sgroi note that their findings need to be validated by additional studies before they can be put into clinical practice.

Source: Massachusetts General Hospital