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References
1.[FDA] U.S. Food and Drug Administration . 2007 a. Draft guidance for industry, clinical laboratories, and FDA staff: in vitro diagnostic multivariate index assays . www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071455.pdf. 2010 April 30 .
2.[FDA] U.S. Food and Drug Administration . 2007 b. FDA clears breast cancer specific molecular prognostic test . www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108836.htm. 2010 April 30 .
3.[FDA] U.S. Food and Drug Administration . 2010 . Medical device recalls: Class 2 recall Agendia MammaPrint . www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=89513. 2010 April 30 .
4.
Ray
T
. 2010 . Faulty reagent caused ‘marginal’ over-reporting of breast cancer recurrence with MammaPrint . www.genomeweb.com/dxpgx/faulty-reagent-caused-marginal-over-reporting-breast-cancer-recurrence-mammaprin. 2010 April 30 .
