Nuvera Biosciences Founder Invited to Present Latest Developments in Diagnostics for Therapy Selection at the Annual San Antonio Breast Cancer Symposium
Published: Dec 11, 2008
Topic: Predictors of Response to Adjuvant Therapy
Date: Friday Dec 12, 2008
Venue: Henry B Gonzalez Convention Center, San Antonio, Texas, USA
Dr. Symmans will provide an overview and perspective on the rapidly developing clinical potential for a new generation of genomic tests to more specifically guide a patient and her (his) oncologist in the planning of adjuvant therapy for newly diagnosed breast cancer.
Although the field of predictive biomarkers has made significant advances scientifically, the decision on what specific therapy is best for each individual patient tumor continues to be difficult. Nuvera Biosciences has addressed the seminal issue of which patients to treat and what to treat them with by developing two genomic assays, NuvoSelect™ eRx and NuvoSelect™ cRx. The assays help determine outcome of endocrine therapy and taxanebased chemotherapy, respectively.
NuvoSelect eRx, an assay developed from genes that are co-expressed with the estrogen receptor (ER) gene, was evaluated for predicting relapse-free survival in 310 patients with ERpositive tumors treated with tamoxifen as the only adjuvant therapy. This independent validation study showed that high assay scorers (therapy responders) had significantly higher (p=0.005) distant relapse-free survival (DRFS) compared to low scorers (non-responders). On the other hand, a separate evaluation of a cohort of patients (n=134) who did not receive any therapy after surgery showed no benefit in DRFS between high and low scorers demonstrating that the assay is specific of therapy outcome rather than of a prognostic effect.
Nuvera has also recently presented advancements (Hatzis et al, ASCO, 2008) in its chemosensitivity predictor, NuvoSelect cRx. This new assay was developed with needle biopsies of HER2-normal, stage I-III breast cancer patients who received neoadjuvant taxane (T/FAC) chemotherapy.
Performance analysis of the predictor using cross-validation showed that patients predicted to have excellent response had significantly better DRFS (p<0.001). More significantly, the predictor was able to show in a subset (n=94) of triple-negative breast tumors, which are typically difficult to treat, that about half of these patients would have excellent prognosis with <10% relapse 5 years after T/FAC treatment whereas the other half, would be resistant to the therapy and have a 60% rate of relapse.
“We believe the uniqueness of our assays is not just their therapy focus but that they can be offered as a single test to analyze one tumor sample and report which treatments are likely to work from a range of standard options,” said Dr. Nandan Padukone, President of Nuvera. “Our tests go right to the heart of the information needed so we can get closer to tailoring treatments and delivering personalized medicine,” he added. Dr. Padukone also explained that the assays are fully validated and the Company is in the process of seeking regulatory approvals needed for marketing. In addition, the NuvoSelect portfolio used to predict therapy outcome can report status of standard tumor markers such as ER and Her2 from the same tumor sample. A prospective clinical trial at M.D. Anderson, planned for early 2009, will use these genomic assays to select treatment options for newly diagnosed patients.
About Nuvera Biosciences, Inc.: Nuvera Biosciences is a venture launched with technology from University of Texas M.D. Anderson Cancer Center, to develop novel molecular diagnostics that will help achieve significantly better treatment selection and outcomes in cancer. Using well-designed clinical studies, high-quality tissue access, and state-of-the-art bioinformatics technology, the Company is building a portfolio of diagnostic tests directed at making personalized medicine a near-term reality. For additional details on Nuvera and its novel molecular diagnostics, please send an email to email@example.com or call 781-938-9418.