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TEST:
M371 test

Company:
mir|detect
Type:
CE-IVDR (New IVDR)

Details

Evidence
News
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.
Cancer:
Germ Cell Tumors
Method:
PCR
Approvals
Date
Cancer
Gene
Drug
By
04/04/24
CE-IVDR (New IVDR)