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Indiana's 1st CAP Accredited Clinical Toxicology Lab Specializing in Urine Drug Testing
ARIA Diagnostics, an independent clinical chemistry laboratory specializing in urine toxicology, earned accreditation from the College of American Pathologists (CAP) for its voluntary participation in the compliance program emphasizing the strictest regulatory standards in the industry. With the NIH and SAMHSA (Substance Abuse and Mental Health Services Administration) reporting an annual 193 billion dollars lost in crime, in work productivity and in health care due to drug abuse, ARIA Diagnostics ...
Posted on: June 24, 2016
FDA Approves First Treatment for Rare Disease in Stem Cell Transplant Patients
The U.S. Food and Drug Administration recently approved Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive disease (VOD) with additional kidney or lung abnormalities after they receive a stem cell transplant from blood or bone marrow called hematopoietic stem cell transplantation (HSCT). This is the first FDA-approved therapy for treatment of severe hepatic VOD, a rare and life-threatening liver condition.HSCT is a procedure performed in some patients to treat ...
Posted on: June 23, 2016
Cepheid Announces European Approval Of Xpert MRSA Next-Generation Screening Test
Cepheid (Nasdaq: CPHD) recentlyy announced commercial availability, outside the United States, of Xpert MRSA NxG, a next generation version of the market-leading molecular diagnostic test for Methicillin-Resistant Staphyloccus aureus (MRSA). Xpert MRSA NxG has been updated to identify mecA- and mecC- containing MRSA strains and detect new and emerging SCCmec subtypes with enhanced performance. The assay has achieved CE-IVD status under the European Directive on In Vitro Diagnostic Medical ...
Posted on: June 22, 2016
DiscoverX Launches KILR Assay Platform for Cancer Immunotherapy Drug Development
DiscoverX Corporation, the leading supplier of innovative cell-based assays and services for drug discovery and development, recentlyy announced the launch of the KILR Retroparticles product line, providing scientists complete flexibility to develop a simple cytotoxicity assay in almost any cell line.Recent advances in the development of cancer immunotherapies using either bi-specific antibody mediated T cell redirection or chimeric antigen receptor T cells (CAR-T), has created strong demand for robust ...
Posted on: June 21, 2016
Great Basin Receives FDA Clearance for First Multiplex Panel
Great Basin Scientific, Inc. (NASDAQ: GBSN), a molecular diagnostics company, recently received U.S. Food & Drug Administration (FDA) 510(k) clearance for its Staph ID/R Blood Culture Panel, following submission in August 2015. The Company received notification of clearance from the FDA on March 25, 2016. This is Great Basin's first multiplex panel to receive FDA clearance, adding to the value and versatility of the company's analyzer, which is capable of performing low-plex, multiplex and ...
Posted on: June 20, 2016
COLA Joins CDC and CLSI in Conducting New Fingerstick Glucose Testing Study
COLA, a national laboratory accreditor and an advocate for quality in laboratory medicine and patient care, has recently joined with the Centers for Disease Control and Prevention (CDC) and the Clinical and Laboratory Standards Institute (CLSI) in conducting a study aimed at improving the impact of laboratory practice guidelines (LPGs) on health care. The study, Improving the Impact of Laboratory Practice Guidelines: A New Paradigm for Metrics, will provide metrics that can then be used to determine and ...
Posted on: June 19, 2016
GSK and Miltenyi Biotec Establish Cell and Gene Therapy Collaboration
GSK and Miltenyi Biotec recently announced a strategic collaboration that will bring together GSK's expertise in developing cell and gene therapy based treatments with Miltenyi Biotec's global leadership in cell processing and related technologies in cell therapy. The collaboration seeks to optimize the manufacture and delivery of these personalized therapies using increased automation and leading edge processing technology.GSK is building a cell and gene therapy R&D platform to underpin development ...
Posted on: June 18, 2016
HC1 and CliniSys Group Form Innovative Partnership
HC1 and CliniSys Group Form Innovative Partnership Hc1.com, inventor of the world's leading healthcare relationship management platform, announced a new partnership with CliniSys Group, the market leading laboratory information management system (LIMS) for pathology labs in the UK and Europe. Through this partnership, CliniSys will deliver a "powered by hc1" pathology CRM and live analytics solution to its current and prospective clients, offering an innovative platform that enables labs to deliver the ...
Posted on: June 17, 2016
Origin Begins Calprotectin Validation Study
Origin Sciences Ltd, a medical technology company developing unique sampling devices and diagnostics for patients with gastrointestinal diseases, has initiated a study to validate its OriCol device for calprotectin testing. The study will compare calprotectin levels in stool and rectal mucus of patients with suspected or confirmed inflammatory bowel disease (IBD).Testing for Calprotectin, a well-validated biomarker of inflammation, is recommended by NICE as a way to help doctors differentiate between ...
Posted on: June 16, 2016
Program Recognizes Medical Laboratories That Reduced Test Overuse and Improved Patient Outcomes
The American Society for Clinical Pathology (ASCP) is launching the inaugural Choosing Wisely Champions program in collaboration with the American Board of Internal Medicine (ABIM) Foundation. The program will recognize individual clinicians, as well as teams of clinicians, and their commitment to the ABIM Foundation's Choosing Wisely Campaign.Since ASCP joined the Choosing Wisely campaign in 2013, many ASCP members have been working to advance its ideals, which are intended to reduce test overuse and to ...
Posted on: June 15, 2016
Phase 3 Study Offers 300 Carefully Selected HIV Patients Options
Phase 3 Study Offers 300 Carefully Selected HIV Patients OptionsCytoDyn Inc. (OTC.QB:CYDY), a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection, recently announced that it submitted a Phase 3 protocol for a monotherapy trial, along with the Topline Report for its Phase 2b monotherapy trial to the U.S. Food and Drug Administration (FDA). This protocol submission was made under the open investigational new drug ...
Posted on: June 14, 2016
GenMark Achieves CE Mark for its ePlex Sample-to-Answer System
GenMark Diagnostics, Inc. (Nasdaq:GNMK), a leading provider of automated, multiplex molecular diagnostic testing systems, recently announced it has achieved CE Mark under the European In-Vitro Diagnostic Devices Directive (98/79/EC) for its ePlex Instrument System and ePlex Respiratory Pathogen Panel."Achieving CE Mark for ePlex has been an important goal for our Company. We are delighted to have accomplished this key milestone and are now focused on installing ePlex Systems in European early adopter ...
Posted on: June 13, 2016
Leica Biosystems and Pathline Team Up to Address Patient Safety
Pathline Emerge, a leading provider of subspecialized anatomic pathology services, has teamed up with Leica Biosystems, a global leader in pathology solutions. In order to fight against medical errors in the laboratory, such as the misidentification of cancer tests, Pathline has implemented Leica Biosystems CEREBRO, a state-of the-art sample tracking and workflow management solution.A new study by patient-safety researchers, led by Martin Makary, a professor of surgery at the Johns Hopkins University ...
Posted on: June 12, 2016
Agilent Technologies Launches New Solutions for Pharma, Biopharma, Metabolomics and Environmental Researchers
Agilent Technologies Inc. (NYSE: A) recently introduced a wide range of systems, software and technologies designed to improve both the speed and accuracy of mass spectrometry. Agilent showcased the new solutions at the annual meeting of the American Society for Mass Spectrometry in San Antonio, Texas."Agilent is a leader in providing solutions for laboratories that analyze food, water, drugs, proteins, peptides, metabolites and a host of other compounds and elements of interest to scientists," said Monty ...
Posted on: June 11, 2016
Philips Meets U.S. Government Security Requirements for Pathology Medical Data
Royal Philips (NYSE: PHG, AEX: PHIA) recently announced that its digital pathology solutions are among the first pathology IT systems and equipment to be certified for compliance with the U.S. Department of Defense (DoD) security requirements, under its DoD Information Assurance Certification and Accreditation Process (DIACAP). As part of this certification, Philips will follow the DoD's Risk Management Framework (RMF) and employ industry best practices for security across all of its digital pathology ...
Posted on: June 10, 2016