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FDA Clears the Focus Diagnostics SimplexaT Flu A/B & RSV Direct Test to Include Eight Circulating Influenza Viruses
As the 2014-2015 flu season begins, Focus Diagnostics, the products business of Quest Diagnostics, announced that its Simplexa Flu A/B & RSV Direct Kit has received FDA clearance for eight additional influenza strains. These strains may pose significant potential health risks and may be circulating this winter. The FDA, which granted 510(k) clearance to the test kit originally in July 2012, cleared additional analytical reactivity to include Flu A H7N9 and H3N2v, among other strains, based on ...
Posted on: December 19, 2014
Cepheid Receives FDA Clearance for Xpert Flu/RSV XC
Cepheid has received clearance from the FDA to market its Xpert Flu/RSV XC, an on-demand molecular test for accurate and reliable determination of Flu A, Flu B, and differentiation of RSV infection. Xpert Flu/RSV XC runs on Cepheid's GeneXpert System, the world's leading molecular diagnostic platform with more than 7,500 systems installed worldwide.Upper respiratory infections are one of the most common reasons for doctor and hospital visits and, in the United States, are the most common illness ...
Posted on: December 17, 2014
Great Basin Submits 510(k) Application to FDA for Group B Strep Assay
Great Basin Scientific Inc., a molecular diagnostics company, has announced it has submitted its Group B Strep assay to the FDA for 510(k) clearance. The submission of the Group B Strep assay comes after the successful completion of a clinical trial that met all the company's objectives. The trial included 518 prospective samples at several hospital-based clinical laboratories in the United States. Great Basin anticipates commercial release of the Group B Strep assay in the second quarter of 2015, pending ...
Posted on: December 16, 2014
Large Studies Show Caris Molecular Intelligence Identifies Targets with Therapeutic Implications
Caris Life Sciences presented data from two large studies in which Caris Molecular Intelligence, the company's panomic, comprehensive tumor profiling service, facilitated the molecular analysis of lung tumors. The biomarker findings from the two data sets, presented at the 2014 Chicago Multidisciplinary Symposium on Thoracic Oncology, have potentially important therapeutic implications for management of patients with small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), and neuroendocrine ...
Posted on: December 14, 2014
Elcam Medical Introduces Minimal Residual Volume Luer Activated Stopcock for Zero Residual Fluids
Marvelous is a state-of-the-art specialized flow-control stopcock used for the administration of IV procedures, including medications, or as a blood sampling port in hemodynamic monitoring sets. Due to its unique design, the Marvelous stopcock ensures maximum safety of patients and medical staff during medical procedures at critical care facilities and outpatient clinics.Marvelous was developed by Elcam Medical Ltd., the leading manufacturer of flow-control medical equipment, with the intention of ...
Posted on: December 12, 2014
QIAGEN to Distribute altona Diagnostic's RealStar Ebolavirus RT-PCR Kit
QIAGEN has announced it will offer global distribution of the altona Diagnostics RealStar Ebolavirus RT-PCR Kit 1.0 after the FDA amended, on Nov. 26, to permit authorized distribution and use in U.S. and certain non-U.S. laboratories, an Emergency Use Authorization (EUA) originally issued on Nov. 10, for this kit. The diagnostic kit, developed and manufactured by altona Diagnostics GmbH, is a reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of RNA ...
Posted on: December 11, 2014
New Measurement of HDL Cholesterol Function Provides Information about Cardiovascular Risk
Groundbreaking research from UT Southwestern Medical Center shows that cholesterol efflux capacity (cholesterol efflux), which measures HDL cholesterol function, appears to be a superior indicator of cardiovascular risk and a better target for therapeutic treatments than standard measurements of HDL. Current measurement methods reflect only the circulating levels of HDL and not the functional properties of this lipoprotein.The latest findings appear online in The New England Journal of Medicine.HDL's key ...
Posted on: December 10, 2014
Triclosan: The Dirty Side of Soap
Triclosan is an antimicrobial commonly found in soaps, shampoos, toothpastes and many other items. Despite its widespread use, researchers at University of California, San Diego School of Medicine report potentially serious consequences of long-term exposure to the chemical. The study, published last month by Proceedings of the National Academy of Sciences, shows that triclosan causes liver fibrosis and cancer in laboratory mice through molecular mechanisms that are also relevant in ...
Posted on: December 09, 2014
Gene Sequencing Projects Link Two Mutations to Ewing Sarcoma Subtype with Poor Prognosis
An international collaboration has identified frequent mutations in two genes that often occur together in Ewing sarcoma (EWS) and that define a subtype of the cancer associated with reduced survival. The research, conducted by the St. Jude Children's Research Hospital-Washington University Pediatric Cancer Genome Project and the Institut Curie-Inserm through the International Cancer Genome Consortium, appears in the current issue of the scientific journal Cancer Discovery.Mutations in the genes STAG2 and ...
Posted on: December 08, 2014
DENARASE Endonuclease Enhances Bioprocesses
DENARASE endonuclease offered by Sartorius Stedim Biotech, a leading global supplier to the biopharmaceutical industry, is a genetically engineered endonuclease from Serratia marcescens and used in purification processes of biological molecules.Because of its high activity and ease of use, DENARASE is often utilized in production of viruses and virus-like particles. The enzyme can be added to the cell lysate to rapidly reduce the large amounts of host-DNA and decrease viscosity, thereby rendering the ...
Posted on: December 07, 2014
Cola White Paper Helps Labs Integrate Practices with Patient Centered Medical Home Model
COLA, the leading U.S. private healthcare accreditor, has released a white paper to assist physician office laboratories (POLs) in aligning their practices with new Patient Centered Medical Home (PCMH) standards. The resource, entitled Integrating Laboratories into the PCMH Model of Health Care Delivery describes principles that practices can incorporate to exceed the National Committee for Quality Assurance (NCQA) standards for PCMH recognition, as well as ...
Posted on: December 05, 2014
DT and Ubiquitome Partner to Develop Mobile Ebola Test
Integrated DNA Technologies (IDT), and Ubiquitome have announced a partnership to develop the Ubiquitome Freedom4 Real-Time RT-PCR Ebola Virus Assay for easy use in the field. This rapid test is designed to be run on Ubiquitome's hand-held, battery powered real-time PCR device, the Freedom4.IDT, a market leader in the manufacture of GMP products for use in molecular diagnostic tests, is leveraging its PrimeTime qPCR Assay platform to develop an assay that will provide accurate and consistent test ...
Posted on: December 04, 2014
EKF Diagnostics Launches POC Hemoglobin Analyzer
EKF Diagnostics, a global diagnostics company, introduced the DiaSpect point of care (POC) hemoglobin analyzer at Medica 2014, last month in Düsseldorf, Germany. Alongside this new product, EKF exhibited a new version of its Hemo Control hemoglobin analyzer, the Biosen glucose and lactate analyzer, as well as previewing SensPoint, a new lactate analyzer designed for use in professional medical settings. The new DiaSpect Tm hemoglobin analyzer is a palm-sized point of care analyzer that is fast, easy ...
Posted on: December 04, 2014
Results from Second Oncotype DX Prostate Cancer Test Clinical Validation and First Decision Impact Study To Be Published
Genomic Health has announced multiple upcoming presentations at this week's 2014 Society of Urologic Oncology (SUO) Annual Meeting, including the second large, independent clinical validation study of the Oncotype DX prostate cancer test and results from the first prostate cancer decision impact study.The results from the latest validation study of the test, conducted in collaboration with the Center for Prostate Disease Research, have been accepted for publication in European Urology. Separately, the ...
Posted on: December 02, 2014