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Utility Of Rubicon Genomics’ ThruPLEX-FD Kit Validated In Study Showing “Liquid Biopsy” Can Track Genomic Evolution Of Cancer In Response To Therapy

Rubicon Genomics, Inc., a leader in the development and commercialization of innovative sample-specific nucleic acid library preparation products used in research and clinical testing, recently reported that its ThruPLEXTM-FD Prep Kits contributed to the success of a breakthrough study recently published in Nature1 that showed that genomic data extracted from the plasma of cancer patients can be used to track drug resistance and potentially guide treatment.

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.

Study Published Showing Advantages of the PAM50 Gene Signature, the Basis for Prosigna, in Helping to Estimate Risk of Late Distant Recurrence in Postmenopausal Estrogen Receptor Positive Breast Cancer Patients

NanoString Technologies, Inc., (NASDAQ: NSTG) a provider of life science tools for translational research and molecular diagnostic products, recently announced that a study published online in the Journal of the National Cancer Institute demonstrated that the PAM50 gene signature, which is the basis for the Prosigna™ Breast Cancer Prognostic Gene Signature Assay, provides important information to help estimate the risk of late distant recurrence in postmenopausal women with estrogen receptor positive (ER+) early-stage breast cancer. After comparing the PAM50 gene signature, the Oncotype DX® Breast Cancer Assay and the IHC4 score, the authors concluded that the PAM50 gene signature provided the strongest prognostic information regarding risk of distant recurrence five to 10 years following diagnosis in postmenopausal ER+ early-stage breast cancer patients treated with five years of endocrine 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