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Archives for September 2013

Genomind Announces New Portal at NEI Global Psychopharmacology Congress

Genomind, a personalized medicine company for neuropsychiatry, is excited to announce its new clinician online portal at the Neuroscience Education Institute (NEI) Global Psychopharmacology Congress in San Diego. Genomind will host a Product Theater at the Congress on Saturday, October 20, 2012 at 7 am, where co-founder and Chief Scientific Officer Dr. Jay Lombard will discuss the Company’s Genecept Assay, introduce attendees to the new system, and showcase the convenient features for clinicians.

The portal is a secure, convenient way for clinicians to easily access their patients’ test results from the Genecept Assay. The Assay is Genomind’s comprehensive, saliva-based test, which looks at genes and biomarkers that may affect the type of medication or treatment a clinician would prescribe to patients suffering from difficult-to-treat psychiatric disorders. The secure site allows clinicians to review and download comprehensive reports via login credentials any time or place, giving flexibility to their busy schedules. All results will be available electronically and can be downloaded directly from the portal. The portal also allows easy access to peer-reviewed study data related to genes in the panel.

The portal is also the home of Genomind’s innovative Open Label Study, which measures the real world use and impact of the Genecept Assay on patient treatment and outcomes. The study has a unique design to enable timely, efficient reporting online for clinicians and patients.

The portal will be accessible on the Genomind website homepage or via email alerts sent to clinicians once their patients’ test results are live and available.

The Neuroscience Education Institute Annual Conference runs from October 18-21, 2012, at the Manchester Grand Hyatt in San Diego. In addition to the Product Theater, Genomind will be available on the main show floor at Booth 115 to share more information about the portal, the Genecept Assay, and their dedication to harnessing the latest research to better treat patients.

Source: Genomind

Study Expands Use of Biomarker for Early Diagnosis of Acute Kidney Injury

A biomarker test developed initially to identify early acute kidney injury (AKI) after surgery has been shown to successfully detect AKI in emergency room patients with a variety of urgent health issues.

In a study published online Sept. 5 in the Clinical Journal of the American Society of Nephrology, the findings expand the overall utility and potential medical settings for using the test, according to researchers.

The test measures the protein neutrophil gelatinase-associated lipocalin (NGAL) as a biomarker of early AKI. It was invented by researchers at Cincinnati Children’s Hospital Medical Center to detect AKI earlier than existing methods, and to more promptly begin treatment.

“The majority of our studies on NGAL have been performed in well controlled settings of hospital-acquired AKI, such as cardiac surgery, contrast administration or other critically ill patients,” said Prasad Devarajan, MD, senior author and director of Nephrology and Hypertension at Cincinnati Children’s. “The purpose of this study was to determine the biomarker’s accuracy in a diverse group of patients admitted from the emergency department, where patients with early signs of AKI are often misdiagnosed.”

The study involved patients admitted through the emergency room of Fernando Fonseca Hospital in Portugal, which also closely collaborated on the study. The findings demonstrate the NGAL test, which uses a single drop of blood and provides results within 15 minutes, was able to accurately distinguish AKI from reversible transient kidney dysfunction.

Of 616 patients who participated in the study, individuals who were subsequently diagnosed with true AKI had the highest levels of NGAL detected at the time of hospital admission. The study also identified a cutoff point in NGAL levels above which the risk of acute kidney injury increases tenfold.

Results of a study previously published in 2008 by Devarajan showed that the NGAL test predicted AKI in pediatric heart surgery patients within hours instead of days, allowing treatment that prevented serious damage to kidneys. Prior to the NGAL test, serum creatinine was the only reliable method for detecting kidney damage; however, the long wait for results often resulted in permanent kidney damage.

With a growing number of patients coming to emergency rooms with community-acquired AKI, Devarajan says having a rapid, reliable method of detecting kidney injury is increasingly important.

“This latest study showed that this simple laboratory test provides an accurate prediction of acute kidney injury and its severity in a diverse clinical setting,” said Devarajan. “The identification of biomarkers that differentiate intrinsic AKI from transient reversible forms of renal dysfunction and predict outcomes is a high priority.”

Study: Plasma NGAL for the Diagnosis of AKI in Patients Admitted from the Emergency Department Setting [Clinical Journal of the American Society of Nephrology]

Source: EurekAlert!

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

Study Identifies Fibroblast Growth Factor 18 as an Ovarian Cancer Biomarker

Ovarian cancer is one of the leading causes of cancer-related death in women and is often not detected until the later stages of disease, which contributes to poor prognosis. Biomarkers that can be used for early diagnosis and outcome have been identified; however, many of these have not been evaluated at the biological and clinical levels. In the current issue of the Journal of Clinical Investigation, Michael Birrer and colleagues at Massachusetts General Hospital identify fibroblast growth factor 18 (FGF18) as a predictive marker for poor overall survival in ovarian cancer patients. Overexpression of the gene encoding FGF18 was associated with enhanced tumor blood vessel formation and expression of cancer promoting cytokines. These data indicate that further studies on the predictive potential FGF18 and its use as a therapeutic target in ovarian cancer are warranted.

Study: FGF18 as a prognostic and therapeutic biomarker in ovarian cancer [The Journal of Clinical Investigation]

Source: EurekAlert!

BIDMC Cardiovascular Institute Researchers Will Lead $4 Million NIH Grant to Study MicroRNAs

A cardiovascular research team from Beth Israel Deaconess Medical Center (BIDMC) and Brigham and Women’s Hospital (BWH), led by BIDMC Principal Investigator Saumya Das, MD, PhD, has been awarded a $4 million Common Fund grant from the National Institutes of Health (NIH) as part of a newly formed program on Extracellular RNA Communication. The five-year grant will focus on identifying microRNA biomarkers in heart disease.

Each year, complications from heart attacks (myocardial infarctions) contribute to more than half a million cases of heart failure and 300,000 cases of sudden cardiac arrest, when the heart suddenly stops. Both of these conditions are closely related to a process known as remodeling, in which the structure and function of the heart changes – or remodels — following a heart attack.

“Our goal is to explore the role that microRNAs play in predicting which heart-attack patients will go on to experience complications,” explains Das, an electrophysiologist in BIDMC’s Cardiovascular Institute and co-director of the cardiovascular genetics program within the Outpatient Cardiovascular Clinic.

“Current strategies used to identify the highest risk patients have often been inaccurate,” he adds. “We think that a blood test that makes use of microRNA biomarkers could replace existing strategies and more accurately predict which patients might experience poor outcomes and thereby identify who would most benefit from frequent monitoring and medical care.” Other investigators who are part of the NIH grant, “Plasma miRNA Predictors of Adverse Mechanical and Electrical Remodeling After Myocardial Infarction,” include BIDMC Director of Cardiovascular Research Anthony Rosenzweig, MD, and BWH investigators Raymond Y. Kwong, MD, MPH, and Mark Sabatine, MD, MPH.

microRNAs are one type of extracellular RNA. Once considered nothing more than genomic “junk,” microRNAs have more recently been recognized as playing a key role in cellular functions. Several years ago, scientists began to recognize that these small, noncoding RNAs were not only found inside cells, but could also be found in blood and other tissue fluids.

Using patient plasma samples from extensively characterized patients who have suffered heart attacks, the scientific team will first identify which specific microRNAs are related to poor heart remodeling. They will then use cell culture and animal models of heart disease to further prioritize which microRNAs play a functional role in disease progression. Finally, the investigators will validate these prioritized microRNAs as prognostic markers for poor health outcomes after heart attacks in a large prospective clinical trial.

“Ultimately, we think that miRNA-based tests could replace current tests to predict which patients might be at risk of complications and, therefore, be good candidates to receive an implanted defibrillator,” says Das. “At the same time, we hope to be able to better predict which individuals are at less risk of complications – and thereby spare them unnecessary and costly procedures.”

Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School, and currently ranks third in National Institutes of Health funding among independent hospitals nationwide.

BIDMC has a network of community partners that includes Beth Israel Deaconess Hospital-Milton, Beth Israel Deaconess Hospital-Needham, Anna Jaques Hospital, Cambridge Health Alliance, Lawrence General Hospital, Signature Health Care, Commonwealth Hematology-Oncology, Beth Israel Deaconess HealthCare, Community Care Alliance, and Atrius Health. BIDMC is also clinically affiliated with the Joslin Diabetes Center and Hebrew Senior Life and is a research partner of Dana-Farber/Harvard Cancer Center. BIDMC is the official hospital of the Boston Red Sox. For more information, visit www.bidmc.org.

Source: Beth Israel Deaconess Medical Center