The M371-Test is a non-automated test with a qualitative interpretation of results that detects the
presence of testicular germ cell tumours (GCT, Type II, Germ Cell Neoplasia in situ derived testicular
germ cell tumour (GCNis-derived TGCT)) and can be used for diagnosis and follow-up monitoring of
this tumour by expert users. The test population includes male adult patients with suspected or
confirmed testicular germ cell tumour (Type II, GCNis-derived TGCT). The test result cannot be used as
the sole primary diagnosis of a testicular germ cell tumour or to detect recurrence. Any positive M371-
Test should be confirmed by an appropriate clinical diagnostic procedure.