Bremerhaven, 7 March 2025 - mir|detect GmbH announced today that the U.S. Food and Drug Administration (FDA) the M371-Test the Breakthrough Device Designation has issued. The M371-Test is a new type of Liquid Biopsy for the precise and non-invasive detection of Testicular cancer.
Significance of the Breakthrough Device Designation
The Breakthrough Device Designation is one of the FDA's highest designations for medical devices. It is only awarded to products that have the potential to significantly improve the diagnosis or treatment of serious diseases.
With this award, the FDA recognises the M371-Test as a pioneering diagnostic tool that can significantly improve the detection and monitoring of testicular cancer.
The Breakthrough Device Programme enables companies to obtain accelerated and closely supervised authorisation. It offers:- Prioritised review by the FDA
- Early and direct exchange with FDA experts
- Shortened decision-making processes for faster market access
The programme thus specifically supports technologies that offer real progress for patients with urgent medical needs.
About the M371-Test
Testicular cancer is the most common cancer in young men. Early and reliable diagnosis is crucial for successful treatment. The M371-Test utilises circulating microRNA biomarkers for the highly sensitive and specific determination of miR-371a-3pa biomarker that is expressed exclusively in testicular germ cell tumours.
Clinical studies show that the M371-Test is clearly superior to traditional serum tumour markers and enables more accurate, non-invasive diagnostics.
Key advantages of the M371-Test:
- Non-invasive: detection of testicular cancer using a simple blood sample
- Higher diagnostic accuracy: outperforms classic serum tumour markers
- Improved follow-up: Supports the assessment of therapy response and relapses
"This Breakthrough Device Designation is an important milestone for mir|detect and a clear endorsement of our technology," said Dr Nina Winter, CEO at mir|detect. mir|detect. "The close cooperation with the FDA enables us to M371-Test more quickly in the USA and thus improve the diagnosis of testicular cancer in the long term."
With the inclusion in the Breakthrough Device Programme Profits mir|detect of prioritised regulatory processes and direct access to FDA expertise - a decisive step on the way to market approval in the United States.
