Bremerhaven, 8 April 2025 - The mir|detect GmbH gives the successful Validation and release of the M371-Test known on two other qPCR systems: the LightCycler PRO from Roche and the CFX96 from Bio-Rad. Both devices were fully approved as part of a comprehensive analytical and clinical evaluation. This means that the CE-IVD-certified blood test for testicular cancer is now available on a total of Five qPCR platforms applicable.
This extension makes the test accessible to an even wider range of laboratories and supports the standardised, reliable and rapid diagnosis of testicular germ cell tumours (TGCTs) in Europe and beyond.
The new instructions for use are available in our Download area available.
Validation confirms high precision and reliability
The validation included extensive tests on detection limit, linearity, precision and diagnostic accuracy. Both devices met all predefined acceptance criteria and showed a high level of conformity with the LightCycler 480 II reference system.
Key performance data:
Measuring range: 9.93 fM to 15.63 pM
limit of detection (LoD): 2.48 dc
Limit of quantification (LoQ): 9.93 dc
Sensitivity: 91.4 % (LightCycler PRO) | 94.3 % (CFX96)
Specificity: 100 % (both devices)
PCR efficiency: 102.1 % (LightCycler PRO) | 98.1 % (CFX96)
Diagnostic accuracy (AUC): 0.997 for both systems
Precision (total standard deviation): ≤ 0.44 CT
These results confirm the same analytical performance of the M371-Test on both platforms. The measured agreement with the clinical diagnosis was 92 % (Cohen's κ = 0.92) and emphasises the diagnostic reliability.
More devices, more availability for laboratories
With the extension to LightCycler PRO and CFX96, laboratories that already use these widely used devices can now also use the M371-Test without additional hardware investment.
"The release on these two platforms was an important step towards further simplifying the application of our test," explains Dr Jan DiesendCTO at mir|detect. "Many laboratories already have CFX96 or LightCycler systems. With this validation, we enable them to get started directly with miRNA-based tumour diagnostics - without having to adapt their infrastructure."
The validation was carried out entirely in accordance with the Regulation (EU) 2017/746 IVDR and approved by the Notified Body. It confirms that the analytical and clinical performance of the M371-Test on both devices is equivalent to the already approved systems (LightCycler 480 II, QuantStudio 5 and AriaDx).
By extending platform compatibility, the test will be available in even more clinical laboratories in future - an important step towards integrating modern molecular diagnostics more closely into everyday clinical practice.
