M371-Test – microRNA Diagnostic for Testicular Germ Cell Tumours

Overview

M371 is a molecular diagnostic assay for the identification and surveillance of testicular germ cell tumours (type II germ cell neoplasia in situ-derived testicular germ cell tumour, or GCNis-derived TGCT). Using microRNA biomarker technology, M371-Test provides sensitive and specific results, as demonstrated in clinical studies, to support earlier diagnosis and follow-up management.

A timeline showing three stages: Suspicion of testicular cancer, Orchidectomy, and Follow Up Monitoring. Each stage is linked to the M371 Test for diagnostic cancer testing, surgical evaluation, and recurrence detection.

Key Features of M371-Test

Sensitivity and specificity
M371 has demonstrated higher sensitivity and specificity for detecting testicular germ cell tumours than classical tumour markers (AFP, β-hCG, LDH) alone.

Non-invasive testing
A standard blood sample replaces the need for more invasive procedures.

Turnaround time
Results support timely diagnosis and intervention within established clinical pathways.

Monitoring over time
Supports tracking of disease progression, recurrence and treatment response, informing patient management alongside clinical assessment.

Who Should Use M371-Test?

Oncologists and urologists managing patients with known or suspected testicular germ cell tumours
Clinicians requiring additional diagnostic information alongside classical serum markers
Use in follow-up surveillance, including monitoring for up to 10 years per clinical guidelines

How M371-Test Works

M371 is a non-automated assay with a qualitative interpretation of results, detecting testicular germ cell tumours (GCNis-derived TGCT) using microRNA biomarker technology. It is intended for use in both diagnosis and follow-up monitoring.

Sample collection: a blood sample is taken from the patient
Analysis: the sample is analysed using qPCR
Results: a detailed report is provided to support clinical decision-making

Clinical Validation and Research

M371 has been validated across multiple clinical studies:

Sensitivity – primary diagnosis: 89% (clinical stage I), 99% (clinical stage II/III); follow-up: 100%
Specificity – primary diagnosis: 96%; follow-up: 96%
Tumour burden and treatment response correlate with miR-371a-3p expression levels
In patients without metastases, miR-371a-3p drops to 2.6% of the pre-operative value within 24 hours of orchiectomy, enabling faster staging
miR-371a-3p is not detectable in other tumour types or testicular conditions, supporting its specificity as a germ cell tumour biomarker
Recurrences are detected reliably, with potential to reduce reliance on CT scans in follow-up care, lowering radiation exposure in a predominantly young patient group

LDH was not considered in the follow-up setting (Belge et al., 2024). Sensitivity for primary diagnosis is reported separately for clinical stage I versus stages II and III.

A table compares sensitivity, specificity, PPV, and NPV of classical markers versus M371 Test in testicular cancer across clinical stages, showing higher values for M371 Test in all categories and stages.

M371-Test and TC100

M371 is also available as part of TC100, EDX Medical’s combined testicular cancer testing pathway, which pairs M371 with classical serum markers (AFP, β-hCG, LDH) for full-spectrum diagnosis and follow-up.

Availability Through EDX Medical

M371-Test is available in the UK through EDX Medical. For ordering information, turnaround times, and pathway integration, please contact EDX Medical.

FAQs

M371 detects miR-371a-3p, a tumour-specific microRNA associated with testicular germ cell tumours, to support diagnosis and follow-up monitoring.

In published clinical studies, M371 has demonstrated sensitivity of up to 99% at primary diagnosis and 100% in follow-up, with specificity of 96% — higher than the sensitivity reported for classical markers (AFP, β-hCG, LDH) in the same studies.

M371 is designed to complement classical markers rather than fully replace them. For services requiring both, see TC100, which combines M371 with AFP, β-hCG and LDH in a single pathway.

Yes. M371 supports long-term surveillance and reliable detection of recurrence, with potential to reduce reliance on repeated CT imaging.

A standard blood sample.

M371-Test can be ordered as a standalone assay. TC100 combines M371 with classical serum markers (AFP, β-hCG, LDH) into a single integrated testing pathway for services that require both.

Ordering Process

Requisition form

Please download, complete and return the application form. This product should only be ordered by clinicians or other medical professional.

TC100 TRF

Testing Process

EDX Medical will ship a sample kit to the specified location and physician, along with instructions for sample procurement. Upon completion of the laboratory analysis, EDX Medical will deliver the comprehensive report to the specified physician within a three-week period.

Create an account

Please complete and submit the form below.

Upon receipt of an invoice from EDX Medical, customer should remit payment by bank transfer (personal accounts) or PO (business accounts).