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Archives for August 2013

Assurex Health Releases Major Update to GeneSight Psychotropic Test Panel

Assurex Health recently announced the release of GeneSight® Psychotropic 2.0, its lead psychiatric pharmacogenomic test panel. This latest GeneSight Psychotropic version has been updated to include four additional medications that now cover a total of 36 of the most commonly prescribed psychotropic medications in the US. The added antidepressant and antipsychotic medications include Viibryd® (vilazodone), Latuda® (lurasidone), Saphris® (asenapine), and Invega® (paliperidone). Additionally, the GeneSight Psychotropic 2.0 report includes information for 17 psychotropic medications that have pharmacogenomic information in their FDA approved labels.

“Assurex Health is committed to bringing the latest clinical and scientific findings to support clinicians and their patients in selecting medications to treat neuropsychiatric disorders,” according to Bryan M. Dechairo, Ph.D., Senior Vice President, Medical Affairs & Clinical Development at Assurex Health. “GeneSight Psychotropic 2.0 now includes recently approved FDA medications, a new gene polymorphism, and easy-to-understand information to help categorize individual psychotropic medications.”

GeneSight is a unique pharmacogenomic treatment decision support product that tests for clinically important genetic variants affecting a patient’s response to psychiatric medications. GeneSight provides information that helps clinicians make informed, evidence-based decisions about proper drug selection, delivered in a simple and easily understood report. Prescribing a medication regimen that is more likely to succeed because it is tailored to an individual patient’s genetic profile can help the clinician better manage the patient’s disease and improve patient outcomes.

A Mayo Clinic prospective clinical study published recently in Translational Psychiatry (Oct. 2012) compared GeneSight-guided prescribing versus treatment-as-usual prescribing in adult patients with a primary diagnosis of a major depressive disorder over an 8 week period. The study found up to a 4-fold increase in symptom improvement for GeneSight-guided patients. An Assurex Health sponsored one-year blinded retrospective study of adult patients with a diagnosis of depressive or anxiety disorder, also published recently in Translational Psychiatry (Mar. 2013), demonstrated that patients taking genetically inappropriate or “red bin” medications based on the GeneSight report had substantially higher rates of medical utilization, 3-fold greater medical absence days, and 4-fold greater medical disability claims than study patients on non-red bin medications.

Source: Assurex Health

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

C2N Diagnostics Announces Collaborative Research Agreement with Cambridge Isotopes

C2N Diagnostics (C2N) recently announced that it has signed a collaborative research and a global, exclusive supplier agreement with Cambridge Isotope Laboratories, Inc (CIL). The partnership guarantees C2N’s future access to mass quantities of highly enriched stable isotopes at predictable prices. These stable isotopes are key reagents to C2N’s platform of Stable Isotope Labeling Kinetic (SILK™)-based biomarkers. Such biomarkers are showing considerable promise to detect early Alzheimer’s pathology (i.e., well before the onset of clinical symptoms) as well as to measure treatment responsiveness in preclinical and clinical drug studies.

C2N gains a research partner in CIL that is the premier manufacturer in the world of stable isotopes used in clinical research and diagnostic applications. Under terms of the agreement, C2N receives from CIL an upfront payment, commercial milestone fees, future supply guarantees of stable isotopes at predictable prices, and large quantities of GMP-grade stable isotope (13C6) labeled leucine (L-Leucine). The L-Leucine will be used in future upcoming clinical validation studies involving C2N’s SILK™-based tests. CIL also commits to making significant investment in its own infrastructure and manufacturing processes. This will ensure CIL’s ability to meet the future demand of stable isotopes that will incorporate into C2N’s tests

“We spent considerable time evaluating the options available to C2N for obtaining access to stable isotopes used in our SILK™ tests. The logistics of having adequate supply of these reagents to enable disease screening on large numbers of at-risk individuals are far from trivial. We concluded that CIL is the best-positioned company in the world to meet our future expected demands in terms of both material quantity and material quality,” stated Dr. Joel B. Braunstein, C2N’s CEO. “Stable isotopes are non-radioactive, perfectly safe for people to consume and to the environment, and offer great sensitivity for tracking the in vivo metabolism of proteins implicated in diseases like Alzheimer’s. This makes them highly desirable diagnostic reagents. As we expand the use of our SILK™-based biomarkers beyond research services and into clinical diagnostic applications, CIL will be an instrumental partner to help us qualify our test kits and to produce L-Leucine under GMP scaled-up conditions.”

Dr. Joel Bradley, CIL’s CEO, commented, “By focusing on ways to diagnose and treat early Alzheimer’s disease, C2N is tackling one of the most important challenges in modern medicine. The company is making encouraging progress toward its ultimate goal of offering a convenient screening test for early Alzheimer’s that can be administered in the ambulatory setting. At CIL, we acknowledge the social and commercial impact of C2N’s efforts. For this reason, CIL is privileged and delighted to assist C2N with its development activities and to become C2N’s exclusive supplier of stable isotopes.”

Source: C2N Diagnostics

Biomarker Predicts Heart Attack Risk Based on Response to Aspirin Therapy

Aspirin has been widely used for more than 50 years as a common, inexpensive blood thinner for patients with heart disease and stroke, but doctors have little understanding of how it works and why some people benefit and others don’t.

Now researchers at Duke Medicine have solved some of the mysteries related to the use of this century-old drug, and developed a blood-based test of gene activity that has been shown to accurately identify who will respond to the therapy.

The new gene expression profile not only measures the effectiveness of aspirin, but also serves as a strong predictor of patients who are at risk for heart attack, according to a study appearing July 3, 2013, in the online edition of the Journal of the American College of Cardiology.

“We recognized the concept of aspirin resistance among a population of patients who have cardiac events or stroke,” said senior author Geoffrey S. Ginsburg, M.D., PhD, director of genomic medicine at Duke’s Institute for Genome Sciences & Policy and executive director of the Center for Personalized Medicine. “We give the same dose to all patients, but maybe some patients need a larger dose of aspirin, or maybe they need to try a different therapy entirely. We need better tools to monitor patients and adjust their care accordingly, and the findings from our study move us in that direction.”

The Duke researchers enlisted three groups of participants – two of healthy volunteers and one comprised of patients with heart disease seen in outpatient cardiology practices.

The healthy volunteers were given a dosage of 325 mg of aspirin daily for up to a month; the heart disease patients had been prescribed a low dose of aspirin as part of their treatment. Blood was then analyzed for the impact of aspirin on RNA expression and the function of platelets, which are the blood cells involved in clotting.

The RNA microarray profiling after aspirin administration revealed a set of 60 co-expressed genes that the researchers call the “aspirin response signature,” which consistently correlated with an insufficient platelet response to aspirin therapy among the healthy subjects as well as the heart disease patients.

The researchers also examined the aspirin response signature in another group of patients who had undergone cardiac catheterizations. They found the signature was also effective in identifying those patients who eventually suffered a heart attack or died.

“The aspirin response signature can determine who is at risk for heart attack and death,” said Deepak Voora, M.D., assistant professor of medicine at Duke and lead author of the study. “There is something about the biology of platelets that determines how well we respond to aspirin and we can now capture that with a genomic signature in blood.”

Ginsburg said the research is progressing to recreate the findings in other populations, and to develop a standardized testing system that could one day move the analysis into daily practice.

“Nearly 60 million people take aspirin regularly to reduce their chances of heart attack and death, but it doesn’t work for everyone,” said Rochelle Long, Ph.D., of the National Institutes of Health’s National Institute of General Medical Sciences, which partly supported the study. “By monitoring gene activity patterns these investigators uncovered a ‘signature’ linked to inadequate responsiveness. This work may eventually lead to a simple blood test to identify those who do not benefit from aspirin, enabling them to seek other therapeutic options.”

In addition to Ginsburg and Voora, study authors include Derek Cyr; Joseph Lucas; Jen-Tsan Chi; Jennifer Dungan; Timothy A. McCaffrey; Richard Katz; L. Kristin Newby; William E. Kraus; Richard C. Becker; and Thomas L. Ortel.

The study received funding from the Duke Institute for Genome Sciences & Policy; the National Institutes of Health (T32HL007101 to DV); the National Center for Research Resources (UL1RR024128); the National Institutes of General Medical Sciences (RC1GM091083); the Centers for Disease Control and Prevention (5U01DD000014); and the David H. Murdock Research Institute.

Study: Aspirin Exposure Reveals Novel Genes Associated with Platelet Function and Cardiovascular Events

Source: Duke Medicine

Study Published in The Journal of Clinical Oncology Demonstrates Advantages of NanoString’s Prosigna Breast Cancer Assay

NanoString Technologies, Inc. (NASDAQ: NSTG), a provider of life science tools for translational research and molecular diagnostic products, recently announced that the TransATAC clinical validation study for its Prosigna Breast Cancer Prognostic Gene Signature Assay, which is based on the PAM50 gene signature, was published in the Journal of Clinical Oncology (JCO). This study, portions of which were initially presented at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium, evaluated the ability of three breast cancer tests to predict risk of distant recurrence after endocrine therapy in postmenopausal women with hormone receptor-positive (HR+) early-stage breast cancer. The authors of the study concluded that the PAM50-based assay provides more prognostic information in endocrine treated patients with HR+ node negative disease than Oncotype DX®, with better differentiation of intermediate and high-risk groups.

The study included 1,017 samples from the landmark ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial of postmenopausal women with HR+ early-stage breast cancer treated with five years of endocrine therapy. The study was performed on RNA extracted from tumor samples by Genomic Health, Inc. for validation of the Oncotype DX® Breast Cancer Assay. The goals of the TransATAC study were to determine if the PAM50 gene signature added prognostic information to clinical-pathological variables and to compare the performance of the PAM50 risk of recurrence (ROR) score, the Oncotype DX recurrence score (RS), and the IHC4 score, derived from immunohistochemical assessment of ER, PR, HER2 and Ki67 genes, in indicating risk of distant recurrence after endocrine therapy. All primary and secondary endpoints of the study were met.

Authors of the study reported that the PAM50 ROR score added prognostic information about the risk of 10-year distant recurrence in addition to that provided by standard clinical-pathological variables in the analysis of all patients studied (p < 0.001). Similar results were achieved in all three prospectively defined clinically important subsets of patients: node-negative (p < 0.001), node-positive (p = 0.002), and HER2-negative (p < 0.001). In addition, the study reported that patients with Luminal A subtype had a lower risk of recurrence than those with the Luminal B subtype further supporting the biological differences between these groups. The authors also concluded that the PAM50 ROR score provided more prognostic information than the widely used Oncotype DX RS. Compared to Oncotype DX RS, PAM50 ROR score categorized fewer patients as intermediate-risk and more as high-risk when using prospectively defined risk cutoffs for low, intermediate and high risk of <10%, 10% to 20% and >20% estimated risk of recurrence, respectively. Moreover, the authors concluded that the PAM50 ROR score provided at least as much information as the IHC4 and may provide more information than IHC4 in the node negative/HER2 negative patient group.

“The publication of the TransATAC study is an important milestone in our ongoing effort to enable genomic testing for breast cancer in local laboratories worldwide,” said Brad Gray, President and Chief Executive Officer of NanoString Technologies. “We look forward to discussing the results and conclusions of this study with oncologists, pathologists, and payers in the European Union and other countries that recognize the CE Mark, as we continue with our commercial launch in those regions.”

Study: Comparison of PAM50 Risk of Recurrence Score With Oncotype DX and IHC4 for Predicting Risk of Distant Recurrence After Endocrine Therapy

Source: Business Wire