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Epic Sciences Partners with University of Pennsylvania’s Abramson Cancer Center on Cancer Therapy Discoveries through Liquid Biopsy

Epic Sciences, Inc. announced today a collaboration with the Abramson Cancer Center of the University of Pennsylvania (Penn) on multiple studies to explore biomarkers, identified by analysis of circulating tumor cells (CTCs) at a single cell resolution, that are predictive of response to personalized cancer therapeutics.

SomaLogic Announces First Early-access Site for SOMAscan Assay

SomaLogic, Inc., recently announced that the Perelman School of Medicine at the University of Pennsylvania is the first biomedical research center that will offer researchers on-site access to the SOMAscan™ assay, the most powerful proteomics platform available today. The assay will be performed at Penn’s Institute for Translational Medicine and Therapeutics (ITMAT), under the leadership of Daniel J. Rader, MD, associate director of ITMAT and chair of the Department of Genetics., and Stephen Master, MD, PhD, assistant professor of Pathology and Laboratory Medicine and director of ITMAT’s Translational Core Laboratory. It is expected that the SOMAscan assay will be fully functional at Penn by midsummer 2014.

Assurex Health Appoints Veteran P&G Consumer Products Executive Virginia Coleman Drosos President to Lead Personalized Medicine Growth

Assurex Health, a personalized medicine company specializing in pharmacogenomics for neuropsychiatric and other disorders, recently announced that Procter & Gamble veteran Virginia “Gina” Coleman Drosos has joined its leadership team in the role of President.

Drosos joins Assurex Health with more than 25 years of global business leadership, innovation, operations and consumer marketing expertise. During her 25 year career at The Procter & Gamble Company (PG), Gina held positions of increasing responsibility in the United States and internationally delivering strong proven results. She most recently served P&G as Group President for Global Beauty Care, a $6 billion global business unit with over 6,000 employees in 120 countries. 

“Gina brings extensive leadership and strong results on global consumer-driven businesses,” said James S. Burns, CEO of Assurex Health. “I’m particularly excited about Gina joining the team because health care is rapidly moving into an era of patient-empowerment, leading a shift to consumer-enabled personalized medicine. In bringing neuropsychiatric pharmacogenomics to a market of 40+ million patients in the U.S. alone, Assurex will benefit from Gina’s experience in creating awareness and cultivating a huge base of patients/consumers/caregivers, 80% of whom are women as the primary medical decision maker.”

Assurex Health’s pharmacogenomic technology is a breakthrough in personalized medicine. Based on each patient’s personal genetic profile, GeneSight tests help clinicians determine the right treatment medications for patients with depression, ADHD, chronic pain and other neuropsychiatric disorders. “Eliminating today’s typical trial and error process for selecting medications can help people reclaim their lives and reduces healthcare costs,” said Drosos. “I look forward to applying my experience leading in the consumer space to help make personalized medicine a standard of care in the industry. With exciting new innovations in the pipeline and our technology-information-consumer platform, I’m confident Assurex will help more physicians and practitioners determine the best treatment options and lead the movement toward consumer-enabled personalized medicine.”

Drosos also serves on the Board of Directors for several major corporations including Signet Jewelers Ltd. (SIG) and American Financial Group (AFG). Drosos earned a Bachelor of Business Administration in Finance from the University of Georgia, a Master of Business Administration from The Wharton School, University of Pennsylvania, and was recognized as one of Fortune’s 50 Most Powerful Women in Business in 2010 and 2011.

Source: PR Newswire

Researchers Agree that Alzheimer’s Test Results Could be Released to Research Participants

A leading group of Alzheimer’s researchers contends that, as biomarkers to detect signals of the disease improve at providing clinically meaningful information, researchers will need guidance on how to constructively disclose test results and track how disclosure impacts both patients and the data collected in research studies. A survey conducted by a group including experts from the Perelman School of Medicine at the University of Pennsylvania found that a majority of Alzheimer’s researchers supported disclosure of results to study participants. The study is published online in Neurology.

“While this is not a call to immediately tell subjects their biomarker results, it does show that the field is moving to a point where experts want to share valid and meaningful results with participants,” said co-senior author Jason Karlawish, MD, professor of Medicine and Medical Ethics and Health Policy. “As we gain more data on the predictive abilities of these measurements, we will need models and methods to effectively reveal results.”

The study surveyed 139 Alzheimer’s clinical trial leaders and coordinators from the Alzheimer’s Disease Neuroimaging Initiative (ADNI) in April 2012, just before the U.S. Food and Drug Administration approved the amyloid-binding radiotracer known as Amyvid (florbetapir). 73 percent of respondents supported disclosing amyloid imaging results to study participants with mild cognitive impairment, whereas 58 percent supported giving amyloid imaging results to those with normal cognition.

Six themes emerged from the survey, regarding participant preferences and cognition levels, researchers’ requests to develop standardized counseling procedures, participant education, and standardization of data-gathering, and concerns regarding potential harms and benefits to participants, as well as the ways disclosure could impact study results.

Currently, ADNI has a policy to not disclose results to participants, but the survey showed a growing trend of experts who would favor revising this policy. In addition to finding amyloid imaging results valuable, Alzheimer’s experts also valued other biomarker data collected in ADNI, such as spinal fluid tests, PET imaging, and other psychometric tests, suggesting that if amyloid imaging results were allowed to be disclosed, it would likely lead to disclosure of other test results.

Study: Using AD biomarker research results for clinical care [Neurology] 

Source: EurekAlert!

Comprehensive Parkinson’s Biomarker Test Has Prognostic and Diagnostic Value, Penn Medicine Team Reports

Perelman School of Medicine researchers at the University of Pennsylvania report the first biomarker results reported from the Parkinson’s Progression Markers Initiative (PPMI), showing that a comprehensive test of protein biomarkers in spinal fluid have prognostic and diagnostic value in early stages of Parkinson’s disease. The study is reported in JAMA Neurology.

Compared to healthy adults, the study found that people with early Parkinson’s had lower levels of amyloid beta, tau and alpha synuclein in their spinal fluid. In addition, those with lower concentrations of tau and alpha synuclein had greater motor dysfunction. And early Parkinson’s patients with low levels of amyloid beta and tau were more likely to be classified as having the postural instability-gait disturbance- dominant (PIGD) motor type of disease, where falling, freezing, and walking difficulty are common.

“Biomarkers for Parkinson’s disease such as these could help us diagnose patients earlier, and we’ve now shown that the simultaneous measurement of a variety of neurodegenerative disease proteins is valuable,” said study senior author Leslie M. Shaw, PhD, professor of Pathology and Laboratory Medicine at Penn Medicine. Dr. Shaw and John Q. Trojanowski, MD, PhD, director of the Penn Udall Center for Parkinson’s Research, are co-leaders of the Bioanalytics Core for the Parkinson’s Progression Markers Initiative, an international observational clinical study sponsored by The Michael J. Fox Foundation for Parkinson’s Research.

The team evaluated spinal fluid collected from baseline visits of the first 102 PPMI participants – 63 with early, untreated Parkinson’s disease and 39 healthy controls. The spinal fluid was evaluated for levels of five biomarkers: amyloid beta, total tau, phosphorylated tau, alpha synuclein and the ratio of total tau to amyloid beta. Spinal fluid measures of amyloid and tau are currently used in research to distinguish Alzheimer’s disease from other neurodegenerative diseases. In contrast to Alzheimer’s, where tau levels are higher than healthy controls, the study found that early Parkinson’s patients had lower levels of tau than healthy controls. One reason, researchers suggest, could be that interactions between tau and alpha synuclein may limit the release of tau into the cerebrospinal fluid of Parkinson’s patients.

“Through PPMI, we are hoping to identify subgroups of Parkinson’s patients whose disease is likely to progress at a different rate, as early as possible,” said Dr. Trojanowski. “Early prediction is critical, for both motor and dementia symptoms.”

The Parkinson’s PIGD motor subtype has been associated with a more rapid cognitive decline as well as greater functional disability. Using the biomarker test, this initial study found that levels of all spinal fluid biomarkers were lower in the PIGD motor subtype than other types of PD as well as healthy controls. In addition, amyloid beta and phosphorylated tau were at lower levels in the PIGD motor subtype, but were no different in tremor or indeterminate subtypes compared to normal controls.

This spinal fluid testing procedure is only being used in research studies, and will be continued to be evaluated and validated in a larger study of the PPMI cohorts.

In addition to leading the Bioanalytics Core of PPMI, Penn’s Parkinson’s Disease and Movement Disorders Center is one of the two dozen trial sites where volunteers are evaluated throughout the PPMI study. The Penn PDMDC has been part of the PPMI group studying people with early Parkinson’s disease as well as healthy adults since 2010, and began enrollment for a new, pre-symptomatic arm of the study in the summer of 2013. The pre-motor arm of PPMI is enrolling participants who do not have Parkinson’s disease and are living with one of three potential risk factors for PD: a reduced sense of smell (hyposmia); rapid eye movement sleep behavior disorder (RBD; a disorder in which the individual acts out his/her dreams); or a mutation in the LRRK2 gene (the single greatest genetic contributor to PD known to date).

“In addition to biomarker tests, validating risk factors could enable earlier detection of the disease and open new avenues in the quest for therapies that could slow or stop disease progression,” said PPMI trial site study leader Matthew Stern, MD, professor of Neurology and director of Penn’s Parkinson’s Disease and Movement Disorders Center.

Study: Association of Cerebrospinal Fluid β-Amyloid 1-42, T-tau, P-tau181, and α-Synuclein Levels With Clinical Features of Drug-Naive Patients With Early Parkinson Disease [JAMA Neurology]

Source: Penn Medicine