IVDT_In Vitro Diagnostics Technology

IVD Technology, November/December 2012

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CONTENTS FEATURES COVER STORY: Point-of-Care Molecular Diagnostic Testing A target-dependent activation step is combined with isothermal amplifi cation, helicase- dependant amplifi cation, and DNA array-based detection on modifi ed silicon chips to create a visually detectable signal. LARRY REA, BRIAN HICKE, WES LINDSEY, MICHAEL MCMAHON, CHARLES OWEN, AND ROBERT JENISON ON THE COVER Photo by Daft_Lion_Studio/istockphoto.com LFT label 2D-Barcode RFID 17 November/December 2012 Vol. 18, No. 6 Ten Economic Motivators for Patient-Centric Diagnostics To lower the costs associated with the burden of managing chronic diseases, the patient's role is changing. IVD manufacturers that adapt to the new patient role by making consumer-friendly devices or simplifying sample collection will remain competitive. BRYCE SADY AND MANFRED SCHOLZ A Modular Approach to Customizing IVD Instruments Lateral Flow Reader Hardware ESEQuant Lateral Flow Studio (LFS)-Software Firmware Workflow A-MF Assay-specific LFS-Method File (a-MF) 29 By adopting a modular OEM approach, the rapid test or private label manufacturer can avoid investing in an R&D program that requires a time-to- market commitment. BERNHARD GERSTENECKER 25 COLUMNS Regulations & Standards 14 Proposed Guidance on IVD Clinical Evidence and Performance Evaluation Manufacturers of IVD devices should be aware of three proposed Global Harmonization Task Force guidance documents on clinical evidence for IVD devices. Maria E. Donawa Final Thoughts CLIA-Waived Tests: Continuing the Conversation The author suggests revising the current CLIA waiver requirements by specifying that any test specifi cally intended for use in a POC or POL setting that is cleared or approved by FDA should be immediately available for use in such settings without restriction. Thomas M. Tsakeris 42 • Bill Seeks to Reform IVD Reimbursement • Idaho Technology Becomes BioFire Diagnostics, Advances Clinical-Dx Goals • By the Numbers IVDTechnology ONLINE On the next page, fi nd out what content is available on IVD Technology's Web site, ivdtechnology.com . 4 IVD TECHNOLOGY | NOVEMBER/DECEMBER 2012 ivdtechnology.com 11 13 Products & Services Ad Index 34 41 TRENDS & PERSPECTIVES DEPARTMENTS Editor's Page 8 10

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