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Top News

Keep up-to-date with the latest trends in management and clinical operation, regulatory changes, and finance.

SpeeDx lands CE mark for multiplex herpes test

Sept. 6, 2016—SpeeDx has received CE-IVD marking for its PlexPCR HSV 1 and 2, VZV multiplex qPCR kit. The multiplex molecular diagnostic test offers a single-well solution to cover the detection and differentiation of three herpes viruses (HSV 1, HSV 2, and varicella zoster virus) in addition to an internal control. Validated for use on multiple lesion specimen types, the ...

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Agena names Genelex as service provider

Sept. 5, 2016—Agena Bioscience announced the successful certification of Genelex as a certified service provider of the MassArray technology. The system is used to identify and validate SNPs, INDELs, CNVs, translocations, somatic mutations, including rare variants, and methylation profiles across a variety of sample types. The flexibility and scalability of the platform are designed to facilitate development of custom panels ...

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Visiun adds population-health reporting

Sept. 5, 2016—Visiun has added new predictive analytics and population-health reporting to its flagship product, Performance Insight. These new predictive analytics, added to the comprehensive test-use module, are designed to enable laboratories to identify high-risk patients with both elevated patient risk and care gaps. These are patients who are more likely to show up in the later stages of disease ...

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Siemens upgrades POC informatics offering

Sept. 2, 2016—Siemens Healthineers has released a software upgrade for the RapidComm Data Management System version 6.0, an informatics solution to centrally manage in vitro diagnostics analyzers and operators at the point of care. In addition to the system’s enhanced productivity and performance features, RapidComm version 6.0 now connects with POC cardiac devices. The software is designed to offer a ...

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Chembio lands HHS grant to develop rapid Zika test

Sept. 2, 2016—A test that could provide a Zika diagnosis for patients less than 30 minutes in doctors’ and other healthcare providers’ offices is moving forward with funding from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response. Chembio Diagnostic Systems of Medford, NY, is developing a lateral-flow serological test to identify ...

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Meridian’s M. pneumonia molecular test cleared

Sept. 2, 2016—Meridian Bioscience has received FDA clearance for a molecular diagnostic test for Mycoplasma pneumonia. The Illumigene Mycoplasma Direct assay, launched earlier this year in Europe, features a simplified three-step procedure. The new procedure is designed to expand Meridian’s customer base by eliminating the need for specialized techniques and training, as well as providing definitive results in less than ...

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Tecan to service Singulex’s SgX Clarity platform

Sept. 1, 2016—Singulex has reached a worldwide service agreement with Tecan Group to deliver comprehensive maintenance and support for its Sgx Clarity System. The system, which is in development and not yet approved for sale, is a fully automated, next-generation platform designed to overcome the existing sensitivity barriers in immunochemistry diagnostics. “The worldwide service agreement with Tecan provides future users ...

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Thermo trial design speeds OK for BRAHMS tests

Sept. 1, 2016—Thermo Fisher Scientific said it pioneered an innovative trial design that helped its license partners, Roche Diagnostics and BioMérieux, achieve FDA clearance within 90 days for the Roche Elecsys BRAHMS PCT and BioMérieux Vidas BRAHMS PCT assays. Together with the Thermo Scientific BRAHMS PCT sensitive Kryptor, these are the only procalcitonin assays cleared for clinical use in the ...

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Sarstedt offers 3.2-ml needleless urine tube

Aug. 31, 2016—Sarstedt has introduced a 3.2-ml volume Urine Monovette tube in a 13mm x 75mm configuration for smaller volume or dimensional requirements. The Urine Monovette system is designed to enable hygienic urine collection and testing without needles, expensive adapters or cups, or transfers. All tubes are manufactured from impact-resistant medical grade plastics and feature secure screw caps for safe handling. ...

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23andMe offers genotyping services to researchers

Aug. 31, 2016—23andMe has launched a Genotyping Services for Research platform, designed to provide scientists with an end-to-end service to incorporate genetic information into their studies. “GSR simplifies the genotyping process and allows any researcher with an IRB-approved study to incorporate genetics into their research, regardless of their own genetics expertise,” Ruby Gadelrab, 23andMe’s vice president of commercial marketing, said ...

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