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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.

Piramal Imaging Announces the Acceptance for Review of [18F] florbetaben by the FDA and EMA for the Visual Detection of beta-amyloid in Alzheimer’s Disease

Piramal Imaging SA, a division of Piramal Enterprises, recently announced that the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted its applications for review of the investigational PET amyloid imaging agent [18F] florbetaben. A New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application to the EMA for [18F] florbetaben use in the visual detection of beta-amyloid in the brains of adults with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline. [18F] florbetaben binds to beta-amyloid plaques in the human brain, a hallmark characteristic in Alzheimer’s disease.

GENOMAS LLC Expands Personalized Medicine Business With Clinical Laboratory Licenses in New York, Florida, California

Genomas®, a biomedical company delivering personalized medicine to modern clinical practice, has been awarded clinical laboratory licenses in three of the most populous States. The company’s Laboratory of Personalized Health received licenses from the New York Department of Health, the Florida Agency for Health Care Administration, and the California Department of Public Health.

Gualberto Ruano, M.D., Ph.D., President of Genomas and Director of the Laboratory of Personalized Health (LPH) stated: “New York, Florida, and California are among the most demanding States in terms of laboratory technical expertise and business credentialing. Now we are determined to bring our clinical pharmacogenetics services to the people of these States and the entire nation.” These key markets herald a national platform for Genomas products in personalized healthcare, medical decision-support and clinical genomic diagnostics.

LPH was certified previously by the Centers for Medicare and Medicaid Services (CMS) under CLIA (Clinical Laboratory Improvement Amendments, and was licensed by the CT Department of Public Health in 2005. In 2012, Genomas had attained credentialing as a Medicare provider and began providing services in Texas and Pennsylvania.

More than 500 clinicians and 5000 patients in Connecticut have already benefited from the Genomas HILOmet PhyzioType® System, which allows personalized management of over 250 drugs to treat mental illness, pain, diabetes, and heart disease. Clinicians access the information through the Personalized Health Portal, which is a secure web-based interface providing data on over 250 different medications. The clinical support extends to 130 neuro-psychiatric drugs (antidepressants, neuroleptics, anticonvulsants, anxiolytics, stimulants, analgesics, hypnotics) and 120 cardio-metabolic drugs (to treat hypertension, diabetes, angina, thrombosis, gastro-esophageal reflux disease, erectile dysfunction, asthma).

In CT, Genomas has established a successful distribution and customer support partnership with Clinical Laboratory Partners (CLP). James Fantus, President and CEO of CLP, and Vice President of Hartford Healthcare Corporation, commented: “It is a great satisfaction to witness a national platform developing through Genomas from Hartford Healthcare partnerships, which include Clinical Laboratory Partners, Hartford Hospital, Institute of Living, and Hospital of Central Connecticut. Genomas is leading Connecticut to national prominence in the clinical practice of personalized medicine.”

Source: Genomas

Merck and GE Healthcare Collaborate on Use of Imaging Biomarkers for Investigational BACE inhibitor Clinical Development Program

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and GE Healthcare recently announced a clinical study collaboration, license and supply agreement for use of [18F]Flutemetamol, an investigational positron emission tomography (PET) imaging agent, to support Merck’s development of 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).

Scanning Innovation Can Improve Personalized Medicine

New combinations of medical imaging technologies hold promise for improved early disease screening, cancer staging, therapeutic assessment, and other aspects of personalized medicine, according to Ge Wang, director of Virginia Tech’s Center for Biomedical Imaging, in a recent paper that appeared in the refereed journal PLoS One.