IVDT_In Vitro Diagnostics Technology

IVD Technology, Fall 2013

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CONTENTS Fall 2013 Vol. 19, No. 4 IVD Industry Pressure Points: Wrangling with Reimbursement Policies FEATURES COVER STORY: Brazil's Billion-Dollar IVD Market 24 18 Speakers at the upcoming IVD Business Strategy Conference weigh in on how ill-considered reimbursement measures are hampering innovation and market growth. NORBERT SPARROW Surface Acoustic Waves Advance POC Diagnostics A smartphone-based biosensor technology allows infectious-disease testing to be performed in minutes. Burdensome regulations and the notorious Brazilcost of doing business make this a challenging market to penetrate. But it's well worth the effort. CARL MCEVOY Delivering Reproducibility in Quantitative Lateral-Flow Assays Lateral fow assay reproducibility is not only infuenced by design and manufacturing, but also by the components used in the assembly of the test, the most critical of which is the reaction membrane. BRENDAN O'FARRELL AND DR KLAUS HOCHLEITNER ON THE COVER Photo by pawel.gaul/istockphoto.com DALE ATHEY Optimizing IVD Disposables Manufacturing 15 20 28 An informed outsourcing strategy can help IVD manufacturers adapt to increasing worldwide pressure on product margins. DONNA HOCHBERG, KATE MCLAUGHLIN, AND JEREMIAH O'CONNOR Performance Comparison of Three Molecular Diagnostic Test Systems 31 The extraction effciency of manual, semi-automated, and fully automated systems is analyzed. IRA ASHMAN TRENDS & PERSPECTIVES COLUMNS Regulations & Standards 10 The Long and Winding Road to FDA Regulation of LDTs • Companion-Diagnostic Products Enter the Mainstream DEPARTMENTS Ad Index 33 Products & Services 34 6 The role of labdeveloped tests has increased substantially since FDA frst mentioned regulating them 21 years ago. Jeffrey N. Gibbs • IVD Product Design Finds Inspiration in Consumer Electronics Devices 7 4 IVD TEC HNOLO G Y | FA L L 2013 magenta cyan yellow black ES323299_IV1309_004.pgs 09.23.2013 21:01 UBM

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