Bremerhaven, 6 May 2025 - The mir|detect GmbH gives the successful Validation and release of the M371-Test on the Roche cobas z 480 system 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 six 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 cobas z 480 is technically closely related to the already validated LightCycler 480 II and fulfils all the requirements for precise and standardised performance of the M371-Test. The aim of the validation was to demonstrate the consistent analytical and clinical performance of the test on an additional platform and thus further increase flexibility for clinical laboratories.
Key performance data:
- Measuring range: 7.45 dm to 15.63 pm
- limit of detection (LoD): 1.86 dc
- Limit of quantification (LoQ): 7.45 dc
- Sensitivity: 100 %
- Specificity: 100 %
- PCR efficiency: 90,6 %
- Linearity: R² = 0.997 over six logarithms
- Cohen's Kappa: 1.000 - perfect match with the clinical diagnosis
All defined acceptance criteria were met. The statistical analysis showed no significant differences between cobas z 480 and LightCycler 480 II. The clinical comparability of both systems is therefore fully guaranteed.
More devices, more availability for laboratories
"With the validation of the cobas z 480, we are creating an additional option for laboratories that use Roche technology," explains Dr Jan DiesendCTO at mir|detect. "This means that even more users can use the M371-Test into existing processes and take testicular cancer diagnostics in their laboratory to the next level."
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 six qPCR systems. This broad compatibility enables easy implementation without additional hardware investment and ensures consistent test performance across different platforms.
