Quantcast

Industry news that matters to you.  Learn more

PatientPartner Improves Adherence in First Independent IRB-Approved Clinical Trial of a Mobile Game Application in Diabetes Patients

Breakthrough clinical trial results for “PatientPartner,” a new mobile game application designed by scientists and researchers at CyberDoctor, document for the first time the effectiveness of a story-driven game in changing health behavior and biomarkers. Results of the clinical trial demonstrating increased adherence among patients with diabetes were announced last month at the Health 2.0 Conference, October 2nd, in Santa Clara, CA. The unique, universal, non-disease specific approach allows PatientPartner to be effective in improving adherence in all patient populations.

New Study Shows Circulating Tumor Cell Enumeration – as Part of Composite Biomarker Panel – May Serve as a Surrogate for Efficacy Response in Metastatic Castration-Resistant Prostate Cancer

Janssen Diagnostics, LLC recently announced results from a study presented at the European Cancer Congress in Amsterdam, Netherlands, that demonstrated circulating tumor cell (CTC) enumeration using CELLSEARCH®, along with lactate dehydrogenase (LDH) as part of a composite biomarker panel, was an efficacy-response surrogate for survival in managing patients with metastatic castration-resistant prostate cancer (mCRPC). The results show mCRPC patients with greater than or equal to five CTCs and an abnormal LDH level at 12 weeks of treatment have a poorer prognosis than those with lower CTC counts and normal LDH values, with a one- and two-year survival probability of 25 percent and 2 percent compared to 82 percent and 46 percent, respectively. Findings suggest therapeutic alternatives should be considered for patients in the high-risk category at 12 weeks.

Joint Assurex Health and Mayo Clinic Study Demonstrates Clinical Utility of Assurex Health’s Pharmacogenomic Test to Guide Treatment of Major Depressive Disorders

Assurex Health, a personalized medicine company focused on pharmacogenomics for neuropsychiatric disorders, recently announced the publication of a joint clinical study conducted by Assurex and Mayo Clinic which provides additional evidence for the effectiveness of the GeneSight pharmacogenomic test over the current method for selecting psychotropic medications. The study results were published on July 24, 2013 in Pharmacogenetics and Genomics. The primary outcome of the study showed a substantially greater baseline to endpoint decrease in depressive symptoms with higher rates of response and remission in the guided GeneSight group over empiric prescribing, which is the current standard of care. These results reinforce the benefit of GeneSight in providing more objective, evidence-based support for clinicians in selecting medications for patients with psychiatric disorders.

The prospective clinical trial, involving 227 participants divided into pharmacogenomic-guided treatment and treatment-as-usual groups, utilized the GeneSight interpretive report to categorize 26 antidepressants and antipsychotics into color-coded green, yellow, and red “bins” based on each participant’s genetic information and pharmacology of the medications. Significantly greater reductions in symptoms were observed for the GeneSight-guided group using multiple symptom rating scales completed by both clinicians and patients. Participants in the GeneSight-guided group experienced an overall greater than 2-fold improvement in both symptoms and likelihood to achieve remission.

Overall, results with GeneSight-guided treatment were superior to unguided treatment-as-usual. The study showed the ability of GeneSight to identify individuals who are likely to have a favorable outcome with specific pharmacotherapies, supporting the clinical utility of the GeneSight test. A four-fold greater improvement in depressive symptoms was observed in the GeneSight-guided group among participants who entered the study on medications most discordant (red-bin) with their pharmacogenomic profile.

Physicians for nearly 94% of patients in the GeneSight-guided group used the report to either switch participants off medications discordant with their genetics to medications in the green bin or to adjust medication dosages according to the participant’s GeneSight report.

These findings replicate and expand on the magnitude of the effect observed in a previous prospective joint clinical study from Assurex and Mayo Clinic published in Translational Psychiatry (Oct. 2012). This smaller study compared GeneSight-guided prescribing versus treatment-as-usual in adult patients with a primary diagnosis of a major depressive disorder over an 8 week period. Furthermore, a one-year blinded retrospective study of adult patients with a diagnosis of depressive or anxiety disorder published in Translational Psychiatry (Mar. 2013) demonstrated that patients taking discordant 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 patients on non-red bin medications.

“Multiple clinical studies have now demonstrated the clinical validity and clinical utility of our integrated, GeneSight combinatorial pharmacogenomic testing platform,” according to Bryan M. Dechairo, Ph.D., Senior Vice President, Medical Affairs & Clinical Development at Assurex Health. “Prescribing a medication regimen that is more likely to succeed because it is tailored to an individual patient’s genetic profile can help clinicians better manage each patient’s disorder and improve clinical outcomes.”

Source: PR Newswire

Thermo Fisher Scientific and Siemens Renew Partnership for Improved Detection of Sepsis Using B·R·A·H·M·S PCT Biomarker

Hospital laboratories outside the U.S. can benefit from a continued availability of the B·R·A·H·M·S PCT™ assay on ADVIA Centaur® systems, allowing them to diagnose sepsis early and safely.

Thermo Fisher and Siemens Healthcare Diagnostics renew their non-exclusive, long-term, royalty-bearing agreement for the use of Thermo Fisher’s Procalcitonin (B·R·A·H·M·S PCT™) technology, currently available as an automated immunoassay on the Siemens ADVIA Centaur® XP and CP systems in all countries outside the United States and China. The agreement extends a long-standing relationship between the companies.

ADVIA Centaur® B·R·A·H·M·S PCT™ immunoassay currently offers clinicians an integrated solution for accurately diagnosing sepsis and monitoring response to antibiotic therapy allowing for improved clinical decision making. The ADVIA Centaur® systems have a large global installed base in hospital clinical laboratories.

The PCT biomarker test is the gold standard for the early detection of sepsis in critically ill patients and is recommended to initiate, monitor and discontinue antibiotic treatment in the presence of relevant bacterial infections. Broader availability of PCT testing will lead to improved hospital management and care of patients with sepsis or at high risk of developing it.

“The continuation of our close collaboration with Siemens significantly increases the global reach of this critical biomarker, making it available to a broader patient population,” said Marc Tremblay, president of Thermo Fisher Scientific’s Clinical Diagnostics division. “The key for preventing sepsis is the early diagnosis of infections. Early diagnosis also reduces the health economic burden of sepsis therapy, a medical condition that is still very common today and accounts for hundreds of thousands of deaths each year. Therefore, PCT supports hospitals in optimizing their service levels and cost effectiveness in today’s challenging economic environment.”

The worldwide number of patients affected by sepsis is estimated to be 20 to 30 million annually and claims more lives than bowel and breast cancer combined. Despite advances in modern medicine, including antibiotics and vaccines, sepsis remains the primary cause of death from infection with hospital mortality rates between 30 to 60%1. Hospital costs to treat severe sepsis in the U.S. are estimated at $16 billion dollars annually. Much of this cost is attributed to misdiagnosis or delayed diagnosis, making rapid, more reliable detection a national, if not global, imperative. Research published in Critical Care Medicine showed that each hour of delay in therapy can decrease chances of patient survival by 7.6 percent.

Source: ThermoFisher Scientific

Ariosa Diagnostics, CHU de Quebec and Genome Canada to Launch Large-Scale Cost-Effectiveness Study of Non-Invasive Prenatal Testing in Canada

A team of researchers led by CHU de Quebec and Universite Laval, have received CAN$10.5 million from Genome Canada, the Canadian Institutes of Health Research (CIHR), Genome Quebec and other partners to conduct a large-scale comparative effectiveness study on non-invasive prenatal screening techniques. Dr. Francois Rousseau and his team will examine current prenatal screening practices for chromosomal conditions, such as Down syndrome, among pregnant women in Canada in order to improve screening approaches and avoid unnecessary procedures.

Each year in Canada, about 450,000 women become pregnant and are offered Down syndrome prenatal screening using biochemical and ultrasound markers. The vast majority will be negative or low risk. However, for positive or high-risk results, those pregnant women are referred to amniocentesis, which is an invasive procedure done to confirm the screening result. Approximately 5% of all biochemical screening results are falsely positive, attributing to unnecessary invasive procedures that pose a 1 in 300 risk for miscarriage.

Genome Quebec is a strong supporter of public-private partnerships, such as the one developed between Ariosa Diagnostics and Dr. Francois Rousseau’s team. The PEGASUS: PErsonalized Genomics for prenatal Aneuploidy Screening USing maternal blood project, made possible through such partnerships in personalized medicine, will help meet women’s healthcare needs by giving them access to safer prenatal screening tests, explains Marc LePage, Genome Quebec’s President and CEO.

The research project aims at independently comparing the performances of different such approaches that involve various combinations of the available tools for screening of chromosomal conditions, as well as to evaluate the cost-effectiveness, the ethical and social aspects of this new technology and to identify and adapt the best implementation tools for users in the health care system. The researchers will recruit 5600 pregnant women (3600 at high-risk of trisomy conditions and 2000 at low-risk). Samples from these women will be tested in parallel using different screening approaches that involve genomic-based NIPT, but also existing or new biochemical and ultrasound screening tools. The samples will be analyzed without knowledge of the true status of the pregnancy outcome. This will provide a comprehensive evaluation of the most efficient ways to improve the prenatal screening techniques widely used today.

Ariosa Diagnostics is one of the major commercial partners for this project and will provide testing for part of this large sample that will include mainly low-risk women. The investigators have chosen the Harmony™ Prenatal Test as the commercially available NIPT assay to be included as one the various screening tests that will be compared.

Dr. Rousseau, Leader of the Project, mentions: “We are happy that Ariosa Diagnostics has joined this effort and provided a significant contribution to this Project. Ariosa’s Harmony test is the most affordable commercial NIPT available, and it was chosen by the research team for this study because it is the most likely to be used in the Canadian context.”

Dr. Thomas Musci, VP of Clinical and Medical Affairs at Ariosa remarked that: “Ariosa, as a core corporate value, is committed to furthering rigorous clinical and scientific study of cell-free DNA technology and the Harmony Prenatal Test in a variety of clinical settings and in a number of different countries. We are extremely pleased to support this collaboration with Genome Canada and fully support the goals of their research efforts.”

Dr. Serge Rivest, Director of the research Centre at the CHU de Qudbec, stated that: “The leadership of the researchers from CHU de Quebec Research Center was key in putting this exceptional academic team together to tackle one of the hottest clinical application of next-generation sequencing in the context of a population-based screening program.”

Source: Ariosa Diagnostics