Bremerhaven, 23 September 2025 - The mir|detect GmbH gives the successful Validation and release of the M371-Test QuantStudio 5 Dx from Thermo Fisher Scientific was announced. With this approval, the CE-IVD-certified blood test for testicular cancer is now available on another widely used qPCR platform. This means that the CE-IVD-certified blood test for testicular cancer is now available on a total of seven 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 QuantStudio 5 Dx is both FDA-approved as well as CE-marked and enables the M371-Test to be used in routine clinical laboratories worldwide. The aim of the validation was to demonstrate the analytical and clinical performance of the M371-Test on this platform and to further expand device compatibility.
Key performance data:
- Measuring range: 3.73 fM to 15.63 pM
- limit of detection (LoD): 1.86 dc
- Limit of quantification (LoQ): 3.73 dc
- Sensitivity: 100 %
- Specificity: 100 %
- PCR efficiency: 92,8 %
- Linearity: R² = 0.992 over six logarithms
- Cohen's Kappa: 1.000 - perfect match with the clinical diagnosis
All acceptance criteria were met. The statistical analysis confirmed a high level of precision and complete clinical agreement between QuantStudio 5 Dx and the previous comparison platform.
More devices, more availability for laboratories
"With the validation of the QuantStudio 5 Dx, the M371-Test available for the first time on a platform that is approved for both research and clinical use," explains Dr Jan DiesendCTO at mir|detect. "This opens up new possibilities for laboratories to easily integrate the test into existing processes - with consistently high diagnostic quality."
The validation was carried out in accordance with the Regulation (EU) 2017/746 IVDR and approved by the Notified Body. The M371-Test is now validated on seven qPCR systems. This broad compatibility enables easy implementation without additional hardware investment and ensures consistent test performance across different platforms.
