Woburn, MA – December 10, 2008 – Nuvera Biosciences, a molecular diagnostics company
focused on developing breast cancer genomic assays, announced that Fraser Symmans, M.D.,
Professor of Pathology at The University of Texas, M.D. Anderson Cancer Center and cofounder
of Nuvera will be an invited speaker in the session on “Molecular Profiling for Guiding
Therapeutic Decisions” at the 31st Annual San Antonio Breast Cancer Symposium
(www.sabcs.org).
Topic: Predictors of Response to Adjuvant Therapy
Date: Friday Dec 12, 2008
Time: 3pm
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 info@nuverabio.com or call 781-938-9418.