IVDT_In Vitro Diagnostics Technology

IVD Technology, Fall 2013

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so-called cost-plus pricing and, in the United States, are tied to CPT codes," says Welcher. Te problem is that these codes do not adequately refect the value or benefts of CDx— which are used to select, stratify, monitor, or predict a patient's response to therapy—in lowering healthcare costs, she adds. "CDx are complex assays, requiring extensive analytical and clinical validation and a higher level of regulatory oversight," says Welcher. Te assays typically are considered high risk by FDA and are classifed as Class III products. "For IVD manufacturers, the cost and risks associated with developing and marketing CDx products are high compared with diagnostic products not tied to a therapeutic decision. If reimbursement issues are not addressed, IVD companies may be less inclined to develop novel technologies and tests that are not reimbursed adequately to cover IVD Business Strategy Conference The global IVD industry is faced with multiple challenges, from reimbursement and regulatory issues to shifting market landscapes. Tese issues and many more will be addressed at the IVD Business Strategy Conference hosted by IVD Technology at the Hilton San Diego Bayfront hotel on November 6 to 8 in San Diego, CA. To learn more about the event and to register, go to www.ivdconference.com. development costs," says Welcher. Tere is some cause for optimism, however. Noting that the reimbursement landscape varies geographically, Welcher adds that there is awareness at CMS for the need to modernize the clinical laboratory fee schedule. "Tis can lead to reimbursement codes that refect the true value of CDx assays," says Welcher. "Te benefts of CDx assays are now being realized in lowering healthcare costs by enabling smaller clinical trial sizes, enabling drugs to get to market faster, and identifying the right patient for the right treatment." To drive positive change, Welcher pins her hopes on pharma and diagnostic companies working together to generate appropriate pharmaceutical and economic data and to lobby for reimbursement reform. IVD 6TFSFQSJOUTUPCVJMEZPVSNBSLFUJOHJOJUJBUJWFTBOE TUSFOHUIFOZPVSDPNQBOZ ).#2%!3% 9/52 %$)4/2)!, %80/352% Call 866.879.9144 or sales@fosterprinting.com Visit us at COPAMED 2013, Hall 08b Stand J31 I VD T EC H N O LO G Y | FALL 2 0 1 3 1 9 magenta cyan yellow black ES320858_IV1309_019.pgs 09.19.2013 05:05 UBM

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