About us
mir|detect develops molecular diagnostic solutions for laboratories and healthcare facilities worldwide. Our location is Bremerhaven.
Our aim is to provide reliable tools that enable more precise and patient-centred care.
mir|detect: Biotechnology from Bremerhaven.
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M371 Proficiency Check
Bremerhaven, October 2025 - The CE-IVD-certified M371-Test for the diagnosis and follow-up of testicular germ cell tumours is now used in numerous laboratories. As clinical use increases, so does the need to continuously ensure the quality and precision of the test results.
To support laboratories in this endeavour mir|detect offers again in 2025 the M371 Proficiency Check . This laboratory comparison programme enables participating facilities to check their measurement results as part of an international comparison and prove their diagnostic performance.
Participating laboratories receive a test kit with all the necessary reagents and five synthetic samples for analysis under routine conditions. After successful participation, mir|detect awards a certificate that documents the diagnostic precision of the laboratory and serves as proof of quality for doctors and patients.
The aim of the programme is to promote a uniformly high quality in the use of M371-Test and to strengthen confidence in miRNA-based diagnostics in everyday clinical practice.
Further information can be found in the M371 Proficiency Check brochure (English).
Registration
Interested laboratories can register until 7th of November 2025 by e-mail with the subject "M371 Proficiency Check" to info@mirdetect.de register or use the contact form .
About mir|detect
The mir|detect GmbH based in Bremerhaven, Germany, develops and produces nucleic acid-based in-vitro diagnostics for the early detection and aftercare of cancer. The CE-IVD-certified flagship product, the M371-Testenables the high-precision diagnosis and monitoring of testicular germ cell tumours. Based on the patented and innovative panta|Q® Technology mir|detect is working on a new generation of liquid biopsy tests.
Contact:
mir|detect GmbH
Fischkai 1 - 27572 Bremerhaven
E-Mail: info@mirdetect.deWeb: www.mirdetect.de
QuantStudio 5 Dx
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.
About mir|detect
The mir|detect GmbH based in Bremerhaven, Germany, develops and produces nucleic acid-based in-vitro diagnostics for the early detection and aftercare of cancer. The CE-IVD-certified flagship product, the M371-Testenables the high-precision diagnosis and monitoring of testicular germ cell tumours. Based on the patented and innovative panta|Q® Technology mir|detect is working on a new generation of liquid biopsy tests.
Contact:
mir|detect GmbH
Fischkai 1 - 27572 Bremerhaven
E-Mail: info@mirdetect.deWeb: www.mirdetect.de
Distribution agreement with Gorea Plus
Bremerhaven, 08 July 2025 - The mir|detect GmbHa company based in Bremerhaven and specialising in molecular diagnostics, has acquired a Distribution agreement with Gorea Plus d.o.o. was concluded. The partnership means that the CE-IVD-certified M371-Test of mir|detect in future also in Croatia be available.
With this co-operation mir|detect continues its European expansion and strengthens the availability of modern miRNA-based diagnostics in Croatia. Gorea Plus, based in Novigrad, is an established distributor of medical and diagnostic products and has many years of experience in the distribution of high-quality laboratory solutions. The company will be responsible for the marketing, distribution and technical support of the M371-Test in the Croatian market.
The M371-Test is a minimally invasive blood test for the diagnosis and aftercare of testicular cancer. It uses the biomarker miR-371a-3pwhich has a significantly higher sensitivity and specificity than conventional serum tumour markers. With a Sensitivity of over 90 % and one Specificity of 100 % the test provides reliable results for the early detection of testicular germ cell tumours (TGCTs). This makes a significant contribution to avoiding overtreatment and reducing the use of stressful imaging procedures.
"With Gorea Plus, we have gained a strong partner who knows the diagnostic needs of the Croatian market very well," says Dr Nina Winter, CEO of mir|detect. "Together, we want to significantly improve access to precise, standardised and IVDR-compliant molecular diagnostics for testicular cancer."
The co-operation with Gorea Plus marks another important step in the European growth strategy of mir|detect. Following the successful introduction of the M371-Test in several countries, the company is expanding its presence in south-east Europe. The aim is to provide doctors and laboratories in the region with access to a reliable, validated and CE-IVD-certified test solution.
Further information can be found in our Sales partner area or under www.gorea-plus.hr to find.
About mir|detect
The mir|detect GmbH based in Bremerhaven, Germany, develops and produces nucleic acid-based in-vitro diagnostics for the early detection and aftercare of cancer. The CE-IVD-certified flagship product, the M371-Testenables the high-precision diagnosis and monitoring of testicular germ cell tumours. Based on the patented and innovative panta|Q® Technology mir|detect is working on a new generation of liquid biopsy tests.
Contact:
mir|detect GmbH
Fischkai 1 - 27572 Bremerhaven
E-Mail: info@mirdetect.deWeb: www.mirdetect.de
cobas z 480
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.
About mir|detect
The mir|detect GmbH based in Bremerhaven, Germany, develops and produces nucleic acid-based in-vitro diagnostics for the early detection and aftercare of cancer. The CE-IVD-certified flagship product, the M371-Testenables the high-precision diagnosis and monitoring of testicular germ cell tumours. Based on the patented and innovative panta|Q® Technology mir|detect is working on a new generation of liquid biopsy tests.
Contact:
mir|detect GmbH
Fischkai 1 - 27572 Bremerhaven
E-Mail: info@mirdetect.deWeb: www.mirdetect.de
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