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Signal Genetics Obtains New York State Approval for MyPRS Multiple Myeloma Prognostic Test
Signal Genetics Inc. (Signal), a commercial stage, molecular diagnostic company focused on providing innovative diagnostic services that help physicians make better-informed decisions concerning the care of their patients suffering from cancer, today announced New York State Department of Health approval of its MyPRS (Myeloma Prognostic Risk Signature) test."With approval of MyPRS by the New York State Department of Health, we are now available in all 50 U.S. states to provide physicians and ...
Posted on: July 23, 2014
Sebia launches its Hemoglobins Atlas
Sebia, a market leader in protein electrophoresis and tests for the diagnosis of hemoglobin disorders, recently debuted its Hemoglobins Atlas. This tool, which has been developed for the first time, is dedicated to helping Sebia's capillary electrophoresis users orientate their diagnosis of hemoglobinopathies. Hemoglobin electrophoresis is an established technique routinely used in clinical laboratories for screening samples for hemoglobinopathies (hemoglobin variants and thalassemia). ...
Posted on: July 22, 2014
Verigene Enteric Pathogens Test Receives FDA Clearance
Nanosphere Inc., a company enhancing the practice of medicine through targeted molecular diagnostics, announced it has received U.S. FDA 510(k) clearance for the bacterial portion of its Verigene Enteric Pathogens Nucleic Acid Test (EP). Clinical studies for the full panel, including two additional viral targets, have been completed and the Company expects clearance of the full EP panel.Verigene EP is an automated in vitro diagnostic test that simultaneously identifies a broad panel of common ...
Posted on: July 21, 2014
QIAGEN's artus GBS QS-RGQ Kit, Developed with IMDx Obtains CE Marking
The artus GBS QS-RGQ Kit, which is intended as an aid in detecting Group B Streptococcus (GBS) colonization in pregnant women, has obtained CE-marking for use with QIAsymphony SP/AS and Rotor-Gene Q instruments. GBS can be responsible for life-threatening bacterial infections in newborns, making screening of pregnant women important in order to initiate treatment and prevent transmission to newborns. Utilizing the automated workflow of the QIAsymphony SP/AS and Rotor-Gene Q instruments, ...
Posted on: July 20, 2014
Eutropics Laboratory Receives CLIA Certification
Eutropics, a privately held company developing novel diagnostic tests that provide predictive insights to cancer patient response to treatment, recently announced that its clinical diagnostics laboratory, located in Cambridge, Mass., has received CLIA certification from CMS. This certification follows receipt of a Massachusetts State license and allows the company to accept clinical samples from most U.S. states. "With CLIA certification, Eutropics has proven capability in executing complex testing in a ...
Posted on: July 18, 2014
Beckman Coulter to Acquire Siemens Healthcare Diagnostics' Clinical Microbiology Business
Beckman Coulter, an indirect wholly-owned subsidiary of Danaher Corporation, announced yesterday that it has entered into a definitive agreement to purchase the clinical microbiology business of Siemens Healthcare Diagnostics. The Siemens clinical microbiology business is an established leader in microbial identification and antibiotic sensitivity testing (ID/AST). The business operates with an installed base of over 6,000 instruments globally. The microbiology product line includes the MicroScan ...
Posted on: July 17, 2014
Inexpensive Cortisol Testing Developed for Smartphones
Researchers have developed a device that uses any smartphone to measure the cortisol concentration in saliva. The device was presented at ICE/ENDO 2014, the joint meeting of the International Society of Endocrinology and the Endocrine Society in Chicago."We have developed a method for measuring cortisol in saliva using a smartphone and a disposable test strip. This innovation enables anyone with a smartphone to measure their salivary cortisol level quickly, accurately, and affordably," said lead study ...
Posted on: July 16, 2014
VA Receives $3 Million NCI Grant to Expand Tissue Sample Collection
The University of Virginia Health System has been awarded more than $3 million from the National Institutes of Health's National Cancer Institute to support and expand a critically important program that makes tissue samples available for research on diseases ranging from breast cancer to lung disease. The five-year grant enables UVA to launch a partnership with Eastern Virginia Medical School (EVMS) and the Medical University of South ...
Posted on: July 14, 2014
Leica Microsystems Releases Leica Application Suite Advanced Fluorescence 4.0
Leica Microsystems has launched the Leica Application Suite Advanced Fluorescence (LAS AF), the software platform for advanced life science research in widefield and confocal microscopy, in its 4.0 version. With LAS AF researchers can now perform 2D image analysis on multi-channel experiments and fully control the environmental conditions of an experiment. In addition, users of widefield systems can now connect to the acquisition station remotely anywhere at any time. A workflow guides users step by step ...
Posted on: July 13, 2014
LabStyle Innovations Reports Positive Results From Launch of Dario Smart Meter
LabStyle Innovations, developer of the Dario Diabetes Management Solution, has provided a positive update on the initial "soft" launch of the Dario Smart Meter in the company's initial target jurisdictions of the United Kingdom, Italy and New Zealand.Dario is a cloud-based, diabetes management solution which includes novel software applications combined with the stylish, 'all-in-one', pocket-sized, Dario Smart Meter that interfaces with a user's mobile device. As previously reported, the initial ...
Posted on: July 11, 2014
NOVA Dx Launches QUANTA Lite Calprotectin to Aid in Diagnosis of IBD
INOVA Diagnostics Inc., a worldwide leading provider of autoimmune diagnostic reagents and systems for the clinical laboratory, has globally launched QUANTA Lite Calprotectin, a new FDA-cleared assay. This important assay, which aids in the diagnosis of Inflammatory Bowel Disease (IBD), can also help differentiate IBD from Irritable Bowel Syndrome (IBS) in conjunction with other laboratory and clinical findings.The accurate detection of calprotectin levels in stool can provide critical information ...
Posted on: July 10, 2014
FDA Approves QIAGEN's artus CMV RGQ MDx Kit to Monitor CMV Viral Load in Organ Transplant Patients
QIAGEN's artus CMV RGQ MDx Kit for human cytomegalovirus (CMV) has been approved by the FDA under a full premarket approval (PMA). The test is theonly FDA-approved PCR-based assay optimized for low- to mid-throughput testing of CMV. With a turn-around time of approximately three hours, the assay provides faster results than other PMA approved tests. artus CMV RGQ MDx runs on QIAGEN's Rotor-Gene Q MDx real-time PCR platform, which was cleared by the FDA in 2012 and is a member of the QIAsymphony ...
Posted on: July 09, 2014
Sequenom Receives U.S. FDA Premarket Clearance
Sequenom Receives U.S. FDA Premarket ClearanceSequenom Inc., a life sciences company providing innovative genetic analysis solutions, has received premarket 510(k) clearance from the FDA to market its IMPACT Dx Factor V Leiden and Factor II Genotyping Test and the IMPACT Dx System. The IMPACT Dx Factor V Leiden and Factor II Genotyping Test is performed on the IMPACT Dx System, and is indicated for use as an aid in the diagnosis of patients with suspected thrombophilia.As previously announced, ...
Posted on: July 08, 2014
Biocartis and Abbott in Partnership to Develop Multiplex Companion Diagnostics Tests
Biocartis and Abbott has announced a collaboration to develop and commercialize companion diagnostics tests. Under the agreement, the companies will leverage Biocartis' molecular diagnostics system, Idylla, and Abbott's regulatory, scientific and commercialization expertise.In partnership with pharmaceutical companies, Biocartis and Abbott will create various biomarker panels for use on the Idylla system, where each marker in the panel has a known clinical significance. Multiplexing, or the ability ...
Posted on: July 07, 2014