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

Beckman releases new version of middleware

Sept. 12, 2018–Beckman Coulter launched version 1.10 of its Remisol Advance middleware system for mid- to high-volume laboratories. Enhancements include a centralized dashboard that combines sample status information (pending, stat, validated, and processed), turnaround time data, and quality control alerts in an intuitive format. “By providing a snapshot display of important analytics in a single location, we are enabling technologists ...

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Fingerstick Sofia 2 Lyme FIA gets FDA clearance, CLIA waiver

Sept. 6, 2018—Quidel has received 510(k) clearance and Clinical Laboratory Improvement Amendments waiver from the FDA to market its Sofia 2 Lyme FIA to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from fingerstick whole blood specimens from patients suspected of B. burgdorferi infection. The test is ...

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Study: SelectMDx cost-effective in four European countries

Aug. 30, 2018—MDxHealth announced that a study validating the cost-effectiveness of SelectMDx for Prostate Cancer has been published in Prostate Cancer and Prostatic Diseases (Govers TM, et al. Epub ahead of print Aug. 20, 2018. doi:10.1038/s41391-018-0076-3). The study evaluates the potential cost-effectiveness of SelectMDx, a noninvasive liquid biopsy test to identify patients at increased risk of aggressive prostate cancer, in a ...

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Agena, PerkinElmer team up

Aug. 24, 2018—Agena Bioscience announced it has entered into a collaboration with PerkinElmer, incorporating the LabChip GX Touch nucleic acid analyzer for quality assessment and quantitation of DNA in the upfront workflow of Agena’s MassArray system. The companies have focused on targeting ctDNA in oncology liquid biopsy, where the combined systems aim to support a low cost, highly robust, single-day ...

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Sysmex enhances customer training with new learning center

Aug. 23, 2018—Sysmex has opened a state-of-the-art 98,000-square-foot Center for Learning in Vernon Hills, Ill. The multimillion-dollar facility provides a training environment for 3,000 customers—who will be taught virtually and on site—and 1,400 Sysmex employees annually. It has more than triple the training capacity of the previous Center for Learning, with two conventional classrooms for laboratory professionals and six classrooms ...

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Techlab gets FDA clearance for H. pylori tests

Aug. 22, 2018—Techlab received FDA 510(k) clearance for its H. Pylori Quik Chek and H. Pylori Chek tests. The tests aim to offer quick and reliable detection of Helicobacter pylori–specific antigen in human fecal specimens. The H. Pylori Quik Chek test is a rapid diagnostic test that detects H. pylori in 30 minutes. The H. Pylori Chek test is a 96-well plate ...

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Precision medicine conference to take place Sept. 12–13

Aug. 21, 2018—Precision medicine strategies and successes in improving patient outcomes are key themes when hospital and health network CEOs and administrators gather in Nashville Sept. 12–13 to hear from innovators at Vanderbilt University Medical Center, Geisinger Health, Northwell Health, Moffitt Cancer Center, and Seattle Children’s Hospital, among others.

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Study: DCISionRT predicts radiation therapy benefit

Aug. 9, 2018—Prelude Corp. announced that Clinical Cancer Research published results from a large cross-validation study of DCISionRT in patients with ductal carcinoma in situ (Bremer T, et al. Epub ahead of print July 27, 2018. doi:10.1158/1078-0432.CCR-18-0842). The multisite study demonstrated that DCISionRT was a strong predictor of radiation benefit and was able to identify patients with significantly elevated recurrence ...

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Beckman releases DxM MicroScan

Aug. 7, 2018—Beckman Coulter announced commercialization of its DxM MicroScan WalkAway system, a diagnostic solution for bacterial identification and antibiotic susceptibility testing that uses direct minimum inhibitory concentrations for detection of antimicrobial resistance. The system’s delivery of gold-standard MIC accuracy helps laboratories achieve their operational goals by reducing costs associated with confirmatory testing, the company says. Added workflow enhancements include ...

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Sysmex, Advanced Instruments offer CSF cell counter

Aug. 6, 2018—Sysmex America and Advanced Instruments announced a partnership that will broaden the Sysmex portfolio with Advanced Instruments’ automated GloCyte cell counter system. The GloCyte system uses a combination of fluorescence, microscopy with digital image analysis, highly specific reagents, and an intelligent counting algorithm to provide accurate counts down to zero for both red blood cell and total nucleated ...

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