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CompanionDx Launches NGS-based Cancer Assays Using GenomOncology’s GO Clinical Workbench

CompanionDx Reference Lab, LLC, a high-complexity CLIA-certified laboratory specializing in pharmacogenomics, cancer companion diagnostics and targeted next-generation sequencing (NGS), recently announced it is offering a series of NGS-based assays related to cancer. To enable efficient and compliant clinical reporting from NGS, CompanionDx chose to partner with GenomOncology, an Ohio-based genomics technology and services provider.

Luminex Corporation Receives FDA and European Clearance for a New Personalized Medicine Genotyping Assay, xTAG CYP2C19 Kit

Luminex Corporation (NASDAQ: LMNX) recently announced it has received U.S. FDA and European clearance for a comprehensive genotyping assay, xTAG® CYP2C19 Kit. This new test enables a personalized approach to aid physicians in determining patient treatment plans based on certain genetic variants of the P450 2C19 gene.

Takeda and Zinfandel Pharmaceuticals Initiate Phase 3 TOMMORROW Trial of AD-4833 for the Delay of Onset of Mild Cognitive Impairment Due to Alzheimer’s Disease in Subjects Selected Using a Genetic-Based Biomarker Risk Assignment Algorithm

Takeda Pharmaceutical Company Limited (“Takeda”) and its partner, Zinfandel Pharmaceuticals, Inc. (“Zinfandel”), recently announced the initiation of TOMMORROW, a global Phase 3 clinical trial investigating a genetic-based biomarker risk assignment algorithm (risk assignment algorithm) to predict risk of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) within a five year period and to evaluate the efficacy of the investigational low dose pioglitazone (designated AD-4833 for this use) in delaying the onset of MCI due to AD in cognitively normal individuals at high risk as determined by the risk assignment algorithm.

The risk assignment algorithm is comprised of apolipoprotein E (APOE) and TOMM40 genotypes and age. Age and APOE genotype have previously been shown to indicate elevated risk of AD. The addition of TOMM40 is hypothesized to further refine the risk determination.

“To date, there have been a number of avenues investigated with the goal of altering the course of Alzheimer’s disease but results have been unsuccessful,” said Allen Roses, M.D., Chief Executive Officer, Zinfandel. “This is why the TOMMORROW trial is important. The potential to identify an individual’s risk for developing MCI due to AD warrants further investigation.”

AD is a devastating disease and diagnoses are increasing as the world’s population ages. Currently 35.6 million people worldwide are living with some form of dementia. Studies show that individuals with MCI are at an increased risk of developing AD or another dementia with conversion rates of approximately 15 percent per year.

“AD-4833 is a member of a class of drugs known as PPAR (peroxisome proliferator-activated receptor)-gamma agonists which available data show may have a beneficial role in delaying symptoms of MCI due to AD,” noted Stephen Brannan, M.D., Central Nervous System Development Therapeutic Area Head, Takeda. “TOMMORROW is a significant study and represents a novel clinical milestone and trial for the Alzheimer’s community as it evaluates pre-symptomatic patients.”

Source: Taleda Pharmaceutical Company Limited

Abbott Announces New Test to Help Doctors Determine Personalized Treatment Path for Patients with Hepatitis C

Abbott recently announced that it has introduced the first FDA-approved hepatitis C virus (HCV) genotyping test for patients in the United States. Abbott’s fully automated RealTime HCV Genotype II test determines the specific type or strain (referred to as the genotype) of the HCV virus present in the blood of an HCV-infected individual. Genotyping the HCV virus provides physicians with important information they can use to create a personalized, targeted diagnosis and treatment path to improve clinical outcomes.

“Hepatitis C is known as the silent killer as many of the symptoms go unnoticed. When patients are identified, determining their specific genotype is important to ensuring they receive the treatment that will prove to be most effective. The introduction of this test for broad use in the U.S. is a significant advancement in helping to address an important public health issue,” said HIV and viral hepatitis expert, Carol Brosgart, M.D., Clinical Professor of Medicine, Division of Global Health, University of California San Francisco.

According to the Centers for Disease Control and Prevention (CDC), more than 75 percent of adults with hepatitis C are baby boomers — born between 1945 and 1965 — and most of them don’t know they are infected. In 2012, the CDC recommended that all baby boomers talk to their doctor and get a one-time test for HCV since this group is five times more likely to have the virus. Once a patient is diagnosed with HCV, a doctor would order a hepatitis C genotype test. The Abbott RealTime HCV Genotype II test is run on the fully automated m2000 platform, which provides laboratories substantial improvements in workflow efficiency to meet the increased demand.

“The Abbott RealTime HCV Genotype II test adds yet another test to the Abbott portfolio for a full spectrum of hepatitis C testing—from ensuring blood supply safety and providing initial screening to enabling targeted diagnoses, identification of the right treatments, and the monitoring of response to therapies,” said John Coulter, vice president, Molecular Diagnostics, Abbott. “Abbott continues to expand diagnostic testing options in the infectious disease area to benefit the healthcare system and enable doctors to improve patient care.”

Source: Abbott

University of Maryland Medical Center Launches Genetic-testing Program for Cardiac Stent Patients

Patients with coronary artery disease who undergo treatment at the University of Maryland Medical Center now can receive long-term therapy based on information found in their genes. As part of a new personalized medicine initiative, the medical center is offering genetic testing to help doctors determine which medication a patient should take after a stenting procedure in order to prevent blood clots that could lead to serious – and potentially fatal – heart attacks and strokes.

Patients with suspected heart disease undergo coronary catheterization to identify blocked or narrow arteries. Tiny tubes, or stents, are often placed in the arteries to keep them open, and, after surgery, patients typically take antiplatelet drugs, such as clopidogrel (Plavix), to prevent platelets – blood cells produced in bone marrow – from sticking together and forming clots.

Now, patients who undergo coronary catheterization at UMMC and the Baltimore VA Medical Center, both of which are affiliated with the University of Maryland School of Medicine, can elect to be tested for variations in a gene called CYP2C19. Up to one-fourth of the U.S. population carries at least one abnormal copy of the CYP2C19 gene, and research has shown that as a result, these individuals do not metabolize the standard anti-clotting medication clopidogrel effectively.

“There is strong clinical data to support pharmacogenetic testing in regard to antiplatelet therapy,” says Alan R. Shuldiner, M.D., the John L. Whitehurst Endowed Professor of Medicine, associate dean for personalized medicine and director of the Program in Personalized and Genomic Medicine at the University of Maryland School of Medicine. “It’s time to incorporate genetics into the complex medical decisions that we make on behalf of our patients.”

In 2009, Dr. Shuldiner led a University of Maryland study, published in JAMA, which showed that patients with a CYP2C19 gene variation exhibited reduced clinical benefit from taking clopidogrel. Based on growing clinical evidence reported in Dr. Shuldiner’s study and others, the U.S. Food and Drug Administration issued a warning about the reduced efficacy of clopidogrel in people with the genetic variation.

“Pharmacogenetic testing enables us to tailor drug treatments to individual patients based on their unique genetic makeup, or genotype,” says Dr. Shuldiner, an endocrinologist and geneticist. “With genotype-directed therapy, we have the ability to change the ‘one size fits all’ approach to prescribing medication and ultimately improve the quality of care we provide to our patients. Patients want personalized and individualized medicine. They seek it out.”

The test is performed by analyzing the patient’s DNA, isolated from a blood sample, in a new state-of-the-art translational genomics laboratory at the University of Maryland School of Medicine. The tests are being conducted as part of a National Institutes of Health (NIH)-funded study to determine the best way to implement genetic-testing programs. Tests are free, and because of the partnership between UMMC and the University of Maryland School of Medicine, results are available within a few hours.

Dr. Shuldiner explains that the ability to provide test results within hours is crucial because cardiac stent patients are at risk for developing blood clots and other complications soon after they have the procedure. “This rapid turnaround time sets our program apart from other programs and commercial laboratories, where results may not be available for up to two weeks,” he adds.

Pharmacogenomics – how genes affect a person’s response to drugs – is a burgeoning area of research, but only a small number of hospitals in the United States have programs to offer routine genetic testing as part of their clinical practice. This new approach to patient care is part of the University of Maryland School of Medicine’s pursuit of more individualized, or personalized, medical treatment.

E. Albert Reece, M.D., Ph.D., M.B.A., vice president for medical affairs at the University of Maryland and the John Z. and Akiko K. Bowers Distinguished Professor and dean of the University of Maryland School of Medicine, says, “Personalized medicine is the future of health care, and we want to be at the forefront of not only advancing the science of genomics, but also using that knowledge in a clinical setting for the benefit of patients. Our Program in Personalized and Genomic Medicine, under Dr. Shuldiner’s direction, is helping to lead the way with this new genetic-testing initiative, created in partnership with the University of Maryland Medical Center and the Baltimore VA Medical Center.”

The University of Maryland launched its initiative in conjunction with a multi-center implementation study, the Translational Pharmacogenetics Project, funded by the NIH Pharmacogenomics Research Network (U01HL105198). Five other major hospitals across the United States are taking part in the study to evaluate the process for building such pharmacogenetic-testing programs.

“We plan to share lessons learned at our respective sites and to develop best practices for implementation of pharmacogenetics in everyday clinical practice. We are putting together a toolbox that will be useful to other institutions,” says Dr. Shuldiner, who is leading the multi-center study. Cardiologists Mark R.Vesely, M.D., and Shawn W. Robinson, M.D., assistant professors of medicine at the School of Medicine who care for patients at UMMC and the Baltimore VA Medical Center, are co-investigators.

It is expected that the test for the CYP2C19 gene variation will become standard care for all patients who receive stents at both medical centers once the initial research phase is completed.

Cardiologists receive guidelines on how to interpret the test results and recommendations for choosing medications. It is up to them to determine the most appropriate treatment for their patients, who might have other medical conditions that need to be considered. The test results also are entered in the electronic medical record, where they can be accessed by other physicians.

“Knowing a patient’s genotype is helping us to make more informed decisions for our patients,” Dr. Vesely says. “A combination of aspirin and clopidogrel is the routine choice of medications many physicians will prescribe for their stent patients. But patients who are likely to have a poor or moderate response may be better protected by other medications or possibly a higher dose of clopidogrel. It comes down to what is best for each patient.”

According to Dr. Vesely, limitations for the alternative medications include their association with higher bleeding rates. “The cost of the medications could also be a factor if patients cannot afford alternative medications or will not take them as prescribed.” Newer anti-clotting medications, such as prasugrel (Effient) and ticagrelor (Brilinta), are more expensive than Plavix, which has been available as a generic since May 2012.

Dr. Robinson notes that the response from patients to genetic testing has been positive. “Patients have been very receptive to discovering this new information about themselves that can possibly have a positive impact on their future cardiovascular health,” he says.

Dr. Shuldiner anticipates that the initiative will be expanded to include tests for other genes that may affect how patients respond to medications such as warfarin, an anticoagulant; simvastatin, a cholesterol-lowering drug; and codeine, a pain reliever. “Providing tailored therapy will better meet the health needs of patients and reduce the harmful side effects that can occur when a person is taking the wrong medication,” he says.

The University of Maryland School of Medicine’s Personalized and Genomic Medicine Program was established in April 2011 to help facilitate the pace of discovery in personalized and genomic medicine; to accelerate the translation of these new discoveries to improve patient care; and to enhance the training and education of future generations of physicians and scientists. The program is funded jointly by the School of Medicine and University of Maryland Medical Center.

Source: University of Maryland Medical Center