Today at 15:30 Greg Fitzgibbon, PhD of Elucigene Diagnostics is giving a satellite talk in partnership with Thermo Fisher Sicentific at ESHG 2015. The talk will be on the recent validation of fragment analysis CE-IVD assays using the new 3500 Dx Series Genetic Analyzer. The assays developed were the upcoming Male Factor Infertility Kit, MFI-Yplus and the CF UK diagnostic panels.
The 3500 Dx Analyzer complies with directive 98/79/EC on In Vitro Diagnostic Medical Devices in specific European countries. The analyzer can be used in both RUO mode for kit development and IVD mode for validation.
Many of the current requirements for IVD kit manufacturers are met by this platform with compliance to ISO13485, including reagent and component traceability. The IVD mode lock down gives a control of methods and protocols and the data received is both reliable and repeatable through the reduced signal variance.
Further Elucigene CE IVD assays will also be validated for use using the 3500 Dx Series. To find out more, please attend the corporate satellite talk at 15:30 at ESHG 2015.