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BMC Health Services Research

, 15:352

First Online: 29 August 2015Received: 30 June 2014Accepted: 21 August 2015DOI: 10.1186-s12913-015-1018-6

Cite this article as: Vyberg, M., Nielsen, S., Røge, R. et al. BMC Health Serv Res 2015 15: 352. doi:10.1186-s12913-015-1018-6


BackgroundTreatment for patients with breast cancer BC is guided by human epidermal growth factor receptor 2 HER2 status. The patient’s HER2 status is assessed using US Food and Drug Administration-approved in vitro diagnostic IVD immunohistochemical IHC tests and laboratory-developed IVD tests. We analysed HER2 testing accuracy using data from the Nordic Immunohistochemistry Quality Control NordiQC HER2 IHC programme; results were used in an economic BC treatment model.

MethodsData were obtained from NordiQC HER2 BC surveys performed from 2008 to 2012. False-negative FN and false-positive FP rates for approved and laboratory-developed IVDs were used to estimate direct costs, loss of survival, productivity benefit and quality-adjusted life-years. In the absence of consistent and accessible clinical and economic data from countries participating in the NordiQC programme, United States productivity data, healthcare costs and patient numbers were used as a surrogate in order to estimate the potential impact of selecting an approved or laboratory-developed IVDs.

ResultsIn total, 1703 tests were performed. Pooled FN rates were 11 % for approved IVDs and 25 % for laboratory-developed IVDs; FP rates were 0 % and 5 %, respectively. Using these FP and FN rates in the economic model and applying them to the United States BC population, approved IVD tests would result in better clinical outcomes, i.e., better survival and fewer disease recurrences-progressions, and lower costs, i.e., total direct costs and lost productivity, versus laboratory-developed IVD tests. Every $1 saved by laboratories by using cheaper reagents could potentially result in approximately $6 additional costs to the healthcare system.

ConclusionsThe results of this analysis suggest that incorrect HER2 test results have far-reaching clinical and economic consequences.

AbbreviationsEBCEarly stage breast cancer

EROestrogen receptor

FISHFluorescence in situ hybridisation

FNFalse negative

FPFalse positive

FDAFood and Drug Administration

HER2Human epidermal growth factor receptor 2


ISHIn situ hybridization

IVDIn vitro diagnostic

MBCMetastatic breast cancer

NEQASNational External Quality Assessment Service

NordiQCNordic Immunohistochemistry Quality Control

PgRProgesterone receptor

QALYQuality-adjusted life-year

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Autor: Mogens Vyberg - Søren Nielsen - Rasmus Røge - Beth Sheppard - Jim Ranger-Moore - Eric Walk - Juliane Gartemann - Ulrich-P


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