Biomarker microRNA-371a-3p - expression in malignancies other than germ-cell tumours

Area of Science:

• Oncology
• Molecular Diagnostics
• Biomarker Research

Background:

• microRNA-371a-3p (M371) is recognized as a highly sensitive and specific serum biomarker for testicular germ cell tumors (GCTs).
• Limited data exists regarding M371 expression in non-testicular malignancies (NTMs).
• Understanding M371 expression in other cancers is crucial for its clinical application.

Purpose of the Study:

• To investigate the expression levels of M371 in patients with non-testicular malignancies (NTMs).
• To evaluate the specificity of the M371-Test for detecting GCTs in the presence of other cancers.

Main Methods:

• Serum M371 levels were quantified in 137 NTM patients across 12 cancer types using the IVDR-certified M371-Test.
• M371 levels were compared between NTM patients, GCT patients (n=20), and healthy male controls (n=20).
• Descriptive statistics were employed to analyze median M371 levels and elevation rates.

Main Results:

• A low false-positive rate (FPR) of 5.84% was observed in patients with NTMs.
• M371 expression was 100% in GCT patients and 0% in controls.
• The M371-Test demonstrated a specificity of 94.90% for GCT detection when considering all NTMs and controls.

Conclusions:

• The M371-Test exhibits a very low false-positive rate in non-GCT malignancies, comparable to healthy individuals.
• The high specificity of 94.9% supports M371's utility in GCT detection.
• Elevated M371 levels were unexpectedly observed in a subset of multiple myeloma patients, warranting further investigation.