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TransBioBC Prototype Diagnostic Kit
The prototype in-vitro diagnostic device (IVD) is based on the Capillary Electrophoresis coupled to Mass Spectrometry (CE-MS) derived urinary biomarker. The diagnostic device is based on the combination of 106 urinary naturally occurring peptides, combined with demographical data in a diagnostic nomogram. The purpose of the IVD is the detection of recurrence/ relapse bladder cancer in patients under surveillance.

The sampling kit is shipped to customers on demand. Sample analysis as well as data processing is performed in a quality controlled laboratory environment based on a CE-MS based assay for urinary biomarkers.

Detailed instructions have been formed to ensure the correct application of the sampling kit. Improper handling of the IVD TransBioBC Kit may affect the test result. The instructions for urine sampling and shipping have been formed based on the standard procedures for clinical routine use and are listed in three different languages.