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OICR Researcher Receives Genome Canada Award to Develop Software for Personalized Medicine

The Ontario Institute for Cancer Research (OICR) and the Ontario Genomics Institute (OGI) recently announced that Dr. Lincoln Stein, OICR’s Program Leader, Informatics and Bio-computing, has been awarded $250,000 through Genome Canada’s Bioinformatics and Computational Biology competition, in partnership with the Canadian Institutes of Health Research (CIHR). Dr. Stein and his colleague Dr. Guanming Wu, aim to develop software that will improve the treatment of cancer patients by enabling physicians to study and visualize the genomic aberrations of individual patients. It will help identify genes related to cancers and other diseases.

Cancer is a disease caused by the accumulation of multiple genetic mutations. Highly specific drugs that target mutated proteins in cancer cells are currently being used to treat the disease. However, since cancer patients have different mutation profiles, a drug that is effective in one may not have the same result in another. Personalized medicine based on genomic data would allow doctors to determine the best targeted therapy for each patient.

“One of OICR’s research priorities is to use personalized medicine to optimize patient treatment decisions,” said Dr. Tom Hudson, OICR’s President and Scientific Director. “This project will be of great value to patients because it will link genomic pathway and network patterns to clinical information such as likelihood of cancer metastasis, recurrence, drug sensitivity and patient overall survival.”

“This project will improve clinical care for individuals with cancer,” said Dr. Mark Poznansky, President and CEO, Ontario Genomics Institute. “Understanding the genetic differences between individuals allows for personalized approaches to medicine, which will have a significant impact on health care in Ontario and the world. OGI is proud to support this important work by Drs. Stein and Wu.”

Source: Ontario Institute for Cancer Research

Quest Diagnostics Launches Novel Rheumatoid Arthritis Tests

Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, recently announced the availability of two new blood tests for aiding the early diagnosis of rheumatoid arthritis (RA), an autoimmune disorder that can cause debilitating joint damage.

The lab-developed tests are based on the proprietary 14-3-3eta protein biomarker through an exclusive license agreement for the U.S. market with Augurex Life Sciences. One test provides results of 14-3-3eta blood levels, while a comprehensive panel provides results of blood levels of the novel marker as well as the conventional RA markers cyclic citrullinated peptide (CCP) antibodies and rheumatoid factor (RF). Higher blood levels may suggest a greater likelihood of RA.

“These novel assays have significant potential to help physicians identify early stage RA, when treatment can often arrest further disease progression and disability,” said Stanley J. Naides, M.D., F.A.C.P., F.A.C.R., medical director, Immunology R&D, Quest Diagnostics. “We believe they are superb examples of the potential of diagnostic insights to promote better outcomes through earlier diagnosis and treatment.”

Diagnosis and initiation of treatment of RA within 12 weeks of symptom onset can help prevent joint damage, improve long-term function, and increase the likelihood of achieving disease remission. Yet, many patients are not diagnosed during this time frame, and conventional lab tests, which evaluate blood levels of CCP antibodies and RF, may fail to identify the disease in an early stage.

Physicians may consider results of RF and CCP antibody tests, along with a medical evaluation and X-rays, to diagnose RA. Elevated blood levels of the 14-3-3eta biomarker outperformed conventional RF or CCP antibody testing in a recent study of early RA, being positive in 60-82% of patients diagnosed with RA compared to RF alone (32-82%) or CCP antibody alone (44-82%). The combination of all three markers further increased sensitivity to 72-100%. In addition, co-morbid conditions, such as type 1 diabetes, osteoporosis and gout, do not abnormally raise blood levels of 14-3-3eta.

“The key to successful treatment of rheumatoid arthritis rests with early diagnosis so that appropriate treatment can be instituted before the appearance of joint damage. We still lack the ability to diagnose this disease early in a substantial proportion of patients who may not then receive timely care. The introduction of 14-3-3eta therefore fulfills an important unmet need for both rheumatologists and primary care physicians,” says Dr. Walter Maksymowych, the principal investigator of several 14-3-3eta studies as well as the International Chair of the Outcomes Measures in Rheumatology Clinical Trials Soluble Biomarker Subcommittee and Medical Research Professor of Medicine and Rheumatologist at the University of Alberta, Canada.

“There are multiple routes that biotechnology companies like Augurex can take to commercialize scientific discoveries for clinical use. We believe that Quest’s expertise in immunology and leading diagnostic services position is the best way for 14-3-3eta to reach US physicians and patients who can benefit most from it,” says Norma Biln, chief executive officer of Augurex, which announced the license agreement with Quest Diagnostics in October 2012.

Quest Diagnostics’ advanced clinical laboratory in San Juan Capistrano, Calif., developed, validated and now offers the new RA tests.

Quest Diagnostics offers a broad menu of immunology diagnostic-information services, including a full menu of diagnostic tests for immune function and autoimmunity.

Source: Quest Diagnostics

New Study Proves Univfy IVF Prediction Tests More Accurate in Predicting IVF Success

Univfy Inc., a pioneer in predictive technology for health care and fertility, recently announced the publication of new research findings in Fertility & Sterility, validating the company’s Univfy PreIVF prediction tests as 1,000-times (likelihood scale) more powerful in predicting the probability of live birth in the first in vitro fertilization (IVF) treatment compared to estimates based on a woman’s age.

The peer-reviewed paper, “Personalized Prediction of First-Cycle In Vitro Fertilization Success,” shows that 86 percent of cases analyzed had significantly different probabilities of success compared to age-based estimates, and nearly 60 percent had a higher probability of live birth based on an analysis of the patients’ complete reproductive profiles. In fact, using the Univfy PreIVF prediction model, 42 percent of patients were found to have a personalized predicted success rate greater than 45 percent, while the age-control model could not differentiate these patients from others in the population.

Proven Accuracy Based on Personalized Prediction

The study is the first to validate that patient data available prior to starting IVF can be used to predict a patient’s chance of success to help her decide whether to pursue a first IVF treatment. The Univfy PreIVF test is an online data test that analyzes each individual’s fertility profile (including age, Body Mass Index (BMI), Day 3 FSH, semen analysis, and prior fertility and medical history) and compares it against data from thousands of IVF cycles to instantly deliver personalized prognosis of IVF success. The retrospective validation study analyzed anonymized IVF data aggregated from more than 13,000 first IVF cycles from three university-affiliated outpatient IVF clinics in the U.S., Canada and Spain.

Personalized Prediction of IVF Success Helps Patients

“Our research findings allow us to use known clinical predictors with much greater predictive power to support patients who are considering IVF for the first time,” said Mylene Yao, M.D., CEO and co-founder of Univfy. “Not knowing their personal chances of IVF success may cause many women to be missing out on a treatment that could be highly effective for them.”

While a higher likelihood of success is welcome news for many couples, the study also suggests predictions based on age alone, or age plus a few factors, could falsely reassure a small percentage of patients. Based on the predicted probability, the Univfy PreIVF test also reports the percentile of a patient’s chances of success, which provides a more balanced perspective to the patient and her doctor.

“An accurate prognosis is equally important for those whose likelihood of success is quite high and for those whose chances are much lower than age-based predictions,” Dr. James Grifo, Program Director of the New York University Fertility Center and Director of the Division of Reproductive Endocrinology and Professor of Obstetrics and Gynecology at the NYU School of Medicine. “Predicting the chances of IVF success for each patient may also support physicians in refining clinical protocols to improve care.”

“More accurate personalized prognoses of potential live birth outcomes with IVF can guide both patients and their physicians with treatment decisions,” said Dr. Gedis Grudzinskas, Consultant in Infertility and Gynaecology at 92 Harley Street, London Bridge Hospital, Princess Grace Hospital and Woodlands Health Centre, London, UK, and Editor of Reproductive Biomedicine Online, an international journal devoted to biomedical research on human reproduction.

Enhancing Care through Predictive Analytics

Previously, advanced predictive modeling that is rigorously validated was not accessible to patients and the broader medical community. Univfy has integrated these research processes with proprietary, analytics-powered platforms to deliver scientifically validated predictive information via a user-friendly interface to patients and providers. The Univfy platforms can also serve point-of-care prognostics or administrative needs in other areas of healthcare, outside of reproductive medicine.

Univfy offers complimentary and confidential analysis to any clinic interested in learning how closely their patient-specific success rates compare to the Univfy PreIVF model. This analysis is feasible even for small or mid-size fertility clinics.

Based on its proven model, Univfy offers two prediction tests for consumers: the Univfy PreIVF for women considering IVF for the first time, and the Univfy PredictIVF for women who have had IVF and are considering another IVF treatment. Both are online tests that patients complete in the privacy of their own home by simply entering their own individual health data. The tests are also available for use in physician offices via Univfy’s clinic platform through a business-to-business model. Semi-customization of prediction tests is also available upon request.

Study: Personalized prediction of first-cycle in vitro fertilization success

Source: Univfy

Merck and Luminex Corporation Enter Agreement to Develop Companion Diagnostic to Support Investigational BACE inhibitor Clinical Development Program for Alzheimer’s Disease

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Luminex Corporation (NASDAQ:LMNX) have signed a collaboration and license agreement to develop a companion diagnostic device that will be evaluated to help screen patients for recruitment into Merck’s clinical development program for MK-8931, a novel oral beta amyloid precursor protein site cleaving enzyme (BACE) inhibitor and Merck’s lead investigational candidate for Alzheimer’s disease (AD). Financial terms were not disclosed.

Investment in a Quebec Public-private Partnership to Support the Use of Personalized Medicine Solutions in the Treatment of Cancer Patients

The Government of Québec announced today a $10 million investment in the Personalized Medicine Partnership for Cancer (PMPC). This public-private partnership will be focused on establishing an integrated approach for the development and implementation of clinical biomarkers and other personalized healthcare solutions to improve the outcome and cost-efficiency of healthcare services provided to cancer patients in the province of Québec and abroad. The investment, to be disbursed over a 4 year period, will be supplemented with $11.1 million of funding from the private sector partners, for a total project value of $21.1 million.

The PMPC will be under the leadership of Caprion Proteome Inc., a Montreal-based biotech company specializing in the discovery and development of protein-based diagnostic biomarkers. The other partners will include the Québec Clinical Research Organization in Cancer (Q-CROC), a multidisciplinary network of clinicians, academic scientists and other members of the medical community involved in clinical and translational cancer research, as well as private partners Oncozyme Pharma Inc., Pfizer Canada Inc., Sanofi Canada Inc. and TELUS Health.

As part of the projects supported through this partnership, state-of-the-art genomic, proteomic, bioinformatic and information technology platforms will be implemented to develop and deploy novel biomarkers and targeted therapeutic strategies in the healthcare system for the treatment of lung, colon and breast cancers: “The sequence of our genome or the profile of the proteins in our blood can be used to accurately predict disease progression or treatment outcome. Our partnership will integrate advanced technology platforms with clinical research to accelerate the development and clinical deployment of novel personalized healthcare solutions. Caprion has pioneered such strategies for years, and with our partners, we are committed to delivering tangible results to provide more targeted diagnosis and treatments for cancer,” said Martin LeBlanc, President and Chief Executive Officer of Caprion Proteome.

Personalized medicine has been coined to describe the use of specific patient information gathered from tumour, blood or other specimens to characterize disease subtype and select the optimal treatment. “The rapid progress in clinical research enables us to decipher the underpinnings of cancer and to develop specific diagnostic tools and targeted drugs to treat specific subtypes of common cancers such as lung, colon or breast. It is critical that these new tools and medicines be deployed for the benefit of patients across Québec,” said Gerald Batist, Professor of Oncology at McGill University and Co-director of the Q-CROC and Director of the Segal Cancer Center at the Jewish General Hospital. “While technology has been progressing rapidly, it will be critical to prepare our healthcare system to integrate the wealth of new molecular information and educate professionals in the practice of personalized medicine,” he added.

The PMPC project stemmed from the Stratégie québécoise de la recherche et de l’innovation (SQRI) that was created by the Government of Québec to advance knowledge and accelerate the deployment of innovative personalized medicine solutions to the bedside. The partnership, in collaboration with the Ministère de la santé et des services sociaux (MSSS), was also built to strengthen the cooperation between the private and the public research sectors including academic healthcare institutions and universities.

Source: PR Newswire