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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Certification
Successful CE2797-Certification of the M371-Test according to IVDR
The one from mir|detect developed M371-Test for the detection and monitoring of testicular germ cell tumours has been approved in accordance with Regulation 2017/746 IVDR since April 2024, making it one of the first IVDR certificates in the EU.
The new EU regulation significantly tightens the regulatory requirements compared to Directive 98/79/EC IVDD and ensures greater safety for patients and users in the use of in-vitro diagnostics.
With the IVDR certification of the M371-Test ensures that the scientific validity as well as the analytical and clinical performance has been extensively tested and confirmed by an independent body.
New cycler
Outstanding diagnostic performance of the M371-Test on new qPCR platforms
mir|detect has the M371-Test for the detection of testicular germ cell tumours has been validated for use on two new qPCR platforms:
- AriaDx (Agilent)
- QuantStudio 5 (ThermoFisher Scientific)
The M371-Test offers the same excellent diagnostic performance on both devices as on the LightCycler 480 II, increasing accessibility for laboratories and thus the number of patients treated by the M371-Test benefit.
The company continues to work mir|detect working flat out on the validation of the M371-Test on the LightCycler PRO (Roche) and the CFX96 (Bio-Rad) for the M371-Test accessible to many patients and users.
Follow-up study
Outstanding diagnostic performance of the M371 test on new qPCR platforms
The M371-Test offers you unrivalled diagnostic accuracy and enables a ground-breaking approach to the treatment of testicular cancer. A landmark study has demonstrated the efficacy of the M371-Test from mir|detect in the detection of recurrences of germ cell tumours of the testis.
Early detection of recurrence is crucial in the follow-up of patients with testicular germ cell tumours. In a recently published study, serum levels of miR-371a-3p were analysed in 258 patients with the M371-Test from mir|detect monitored. During the follow-up period, 39 relapses occurred. Elevated levels of miRNA were detected in all of these cases, which corresponds to a sensitivity and specificity of 100 % and 96.3 % respectively. This means that miR-371a-3p clearly outperforms the classic serum markers.
These results emphasise the suitability of the M371-Test from mir|detect for the detection of recurrences, and the test thus represents a significant advance in the follow-up care of testicular cancer patients. The paper was published in Clinical Cancer Research and is now available online: https://doi.org/10.1158/1078-0432.ccr-23-0730
Sales conference
Gold Standard Diagnostics visits Bremerhaven
On 12 May 2023, we received a visit from a team from our exclusive sales partner Gold Standard Diagnostik at our offices in Bremerhaven.
We are proud to continue on the path we embarked on in November 2022 with this well-connected and established partner across Europe and look forward to continuing our intensive and fruitful collaboration.
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We currently have no vacancies.
