{"id":7170,"date":"2025-08-25T10:28:01","date_gmt":"2025-08-25T08:28:01","guid":{"rendered":"https:\/\/www.mirdetect.de\/?page_id=7170"},"modified":"2025-10-15T14:52:04","modified_gmt":"2025-10-15T12:52:04","slug":"technologie","status":"publish","type":"page","link":"https:\/\/www.mirdetect.de\/en\/technologie\/","title":{"rendered":"How it works: M371 | The testicular cancer detector"},"content":{"rendered":"
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M371-Test<\/b> | The future of testicular cancer diagnostics<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The innovative M371-Test from mir|detect detects the tumour-specific miR-371a-3p by means of a minimally invasive blood draw.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Background<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Biotracing<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Previous standard diagnostics<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Testicular cancer is the most common cancer in men between the ages of 20 and 45. In Europe alone, there are 25,000 new cases per year and around 60,000 new cases per year worldwide.<\/p>

Due to their low sensitivity and specificity, conventional serum tumour markers do not provide very reliable results, leaving considerable uncertainty.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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In addition, patients who have tested positive and undergone surgery are exposed to considerable cytotoxic radiation from computerised tomography scans (CT scans) as part of their follow-up care. Although the alternative use of magnetic resonance imaging (MRI) for imaging avoids radiation exposure, MRI also causes immense costs in the healthcare system. In view of the fact that a testicular cancer patient must be examined repeatedly (on average up to 19 times) over a period of up to 10 years after initial diagnosis, which includes 2 to 4 imaging examinations per year (CT), it is clear that this is associated with a considerable burden on the patient and also on the healthcare system.

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Through the use of the M371-Test<\/strong> the use of CT and MRI examinations can be significantly reduced.

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The innovative new development detects the tumour-specific miR-371a-3p<\/strong> in minimally invasive blood samples. The concentration of miRNA in a blood sample is determined by quantitative real-time PCR. The sensitivity and reproducibility of this method for detecting miRNAs, which are often present in low concentrations, is increased by upstream pre-amplification.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Technology<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Biotracing<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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HOW OUR HIGH-PERFORMANCE TUMOUR TEST WORKS<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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mir|detect<\/strong> has developed the innovative and patented panta|Q\u00ae<\/sup>-technology<\/strong> to improve the sensitivity and reproducibility of nucleic acid amplification tests (NAT) in diagnostics. The M371-Test<\/strong>, developed by mir|detect<\/strong> based on the panta|Q\u00ae<\/sup>-technology<\/strong>, quantifies the for testicular cancer specific miR-371a-3p <\/strong>which is released by the tumour cells and can be detected in the patient's blood sample. The determination of the concentration of the germ cell tumour-specific miR-371a-3p<\/strong> provides a reliable indication of the presence of testicular cancer. The sensitivity and specificity of this procedure clearly surpasses the informative value of the classic serum tumour markers.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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The panta|Q\u00ae<\/sup>-technology<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The by\u00a0mir|detect<\/strong> developed and patented panta|Q\u00ae<\/sup>-technology<\/strong> sets new standards in sensitivity and robustness in the detection of disease-specific nucleic acids. The technology has extensive patent protection and enables the development of a broad spectrum of nucleic acid-based tests.<\/p>

Are you interested in using the panta|Q\u00ae<\/sup>-technology<\/strong> for your in-vitro diagnostic? Get in touch with us!<\/a><\/b><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Our M371-Test<\/strong> has the potential to improve the diagnosis and treatment process for testicular cancer patients, medical staff and insurance companies at every level. The test enables faster and more individualised treatment decisions to be made and therefore also the possibility of cost savings. By detecting the smallest amounts of tumour-specific miR-371a-3p<\/strong> in a blood sample, the M371-Test<\/strong> can also be used in primary diagnostics in order to make a clear diagnosis more quickly and reliably.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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DIAGNOSTICS & therapy success<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The M371-Test<\/strong> is of great importance not only in primary diagnostics but also in monitoring the success of therapy.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Through the early detection of tumour-specific miR-371a-3p<\/strong> in blood samples, doctors can diagnose testicular cancer more quickly and effectively and monitor the success of therapeutic measures. The M371-Test<\/strong> can indicate remaining tumour masses and enable patients to receive personalised treatment.<\/p><\/div><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Follow-up monitoring<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Successful treatment is followed by extensive follow-up monitoring, which can last up to 10 years in the case of testicular cancer. The M371-Test<\/strong> can be used to closely monitor changes in health status.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Due to the high recurrence rate of testicular cancer, long-term follow-up care over a period of up to 10 years is required after successful initial treatment. The M371-Test<\/strong> reliably detects recurrent tumours at an early stage. This enables treatment to be initiated early and thus increases the likelihood of success. By avoiding radiation-intensive examination methods (CT), the risk of secondary cancers can be reduced at the same time.<\/p><\/div><\/div><\/div><\/div><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Application<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Biotracing<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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HOW TO USE the M371 test<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Studies & more<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Biotracing<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Clinical studies on the suitability of the M371-Test in testicular cancer diagnostics <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/i><\/span>\n\t\t\t<\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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Use in primary diagnostics<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The suitability of the M371-Test<\/strong> for primary diagnostics was evaluated in a multicentre clinical study involving 37 centres in several European countries (DE, AT, CH, IT, HU).<\/p>

Due to its large size with 522 patients (primary diagnosis only) and 258 control subjects, this study is highly informative. The M371-Test<\/strong> achieved excellent results with a sensitivity of 90 % and a specificity of 94 % and proved to be clearly superior to the classic serum tumour markers (Dieckmann et al., 2019).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Use in Follow-up monitoring<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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On the suitability of the M371-Test<\/strong> A comprehensive, prospective study is available on the follow-up care of testicular cancer patients. In this study, 258 patients were followed up over a period of up to 48 months (median: 18 months). During the observation period, 39 recurrences (15 %) occurred. The result of the M371-Test<\/strong> was positive in all these cases, resulting in a sensitivity of 100 %. In contrast, the serum tumour markers AFP and \u00df-hCG in combination achieved a sensitivity of only 45 % (Belge et al., 2024).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Performance data for the M371-Test<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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1<\/sup> n = 522 patients; 258 controls (Dieckmann et al.<\/i>, 2019; https:\/\/doi.org\/10.1200\/jco.18.01480<\/a>)
2<\/sup> n = 258 patients (Belgium et al.<\/i>, 2024; https:\/\/doi.org\/10.1158\/1078-0432.ccr-23-0730<\/a>)
Classic markers: AFP (\u03b1-fetoprotein), bHCG (\u03b2-subunit of human chorionic gonadotropin) and LDH (lactate dehydrogenase)<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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Selected publications <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/i><\/span>\n\t\t\t<\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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SELECTED PUBLICATIONS<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Dieckmann KP, Radtke A, Geczi L, Matthies C, Anheuser P, Eckardt U, Sommer J, Zengerling F, Trenti E, Pichler R, Belz H, Zastrow S, Winter A, Melchior S, Hammel J, Kranz J, Bolten M, Krege S, Haben B, Loidl W, Ruf CG, Heinzelbecker J, Heidenreich A, Cremers JF, Oing C, Hermanns T, Fankhauser CD, Gillessen S, Reichegger H, Cathomas R, Pichler M, Hentrich M, Eredics K, Lorch A, W\u00fclfing C, Peine S, Wosniok W, Bokemeyer C, Belge G. 2019. serum Levels of MicroRNA-371a-3p (M371 Test) as a New Biomarker of Testicular Germ Cell Tumours: Results of a Prospective Multicentric Study. J Clin Oncol. 37: 1412-1423. https:\/\/doi.org\/10.1200\/jco.18.01480<\/a><\/p>

Belge G, Dumlupinar C, Nestler T, Klemke M, T\u00f6rzs\u00f6k P, Trenti E, Pichler R, Loidl W, Che Y, Hiester A, Matthies C, Pichler M, Paffenholz P, Kluth L, Wenzel M, Sommer J, Heinzelbecker J, Schriefer P, Winter A, Zengerling F, Kramer MW, Lengert M, Frey J, Heidenreich A, W\u00fclfing C, Radtke A, Dieckmann KP. 2024. detection of Recurrence through microRNA-371a-3p Serum Levels in a Follow-up of Stage I Testicular Germ Cell Tumours in the DRKS-00019223 Study. Clin Cancer Res. 30: 404-412. https:\/\/doi.org\/10.1158\/1078-0432.ccr-23-0730<\/a><\/p>

Sohaib SA, Koh DM, Husband JE. 2008. the role of imaging in the diagnosis, staging, and management of testicular cancer. AJR Am J Roentgenol. 191: 387-395. https:\/\/doi.org\/10.2214\/ajr.07.2758<\/a><\/p>

Dieckmann KP, Belge G. 2024. testicular tumour - what are the advantages of the new tumour marker microRNA-371a-3p (M371-Test). Current Urol. 55: 510-519. https:\/\/doi.org\/10.1055\/a-2358-8355<\/a><\/p>

Le\u00e3o R, van Agthoven T, Figueiredo A, Jewett MAS, Fadaak K, Sweet J, Ahmad AE, Anson-Cartwright L, Chung P, Hansen A, Warde P, Castelo-Branco P, O'Malley M, Bedard PL, Looijenga LHJ, Hamilton RJ. 2018. serum miRNA Predicts Viable Disease after Chemotherapy in Patients with Testicular Nonseminoma Germ Cell Tumour. J Urol. 200: 126-135. https:\/\/doi.org\/10.1016\/j.juro.2018.02.068<\/a><\/p>

Tavares NT, Henrique R, Jer\u00f3nimo C, Lobo J. 2025. Current Role of MicroRNAs in the Diagnosis and Clinical Management of Germ Cell Tumours. Surg Pathol Clin. 18: 91-100. https:\/\/doi.org\/10.1016\/j.path.2024.08.003<\/a><\/p>

Spiekermann M, Belge G, Winter N, Ikogho R, Balks T, Bullerdiek J, Dieckmann KP. 2015. microRNA miR-371a-3p in serum of patients with germ cell tumours: evaluations for establishing a serum biomarker. Andrology. 3: 78-84. https:\/\/doi.org\/10.1111\/j.2047-2927.2014.00269.x<\/a><\/p>

Dieckmann KP, Radtke A, Spiekermann M, Balks T, Matthies C, Becker P, Ruf C, Oing C, Oechsle K, Bokemeyer C, Hammel J, Melchior S, Wosniok W, Belge G. 2017. Serum Levels of MicroRNA miR-371a-3p: A Sensitive and Specific New Biomarker for Germ Cell Tumours. Eur Urol. 71: 213-220. https:\/\/doi.org\/10.1016\/j.eururo.2016.07.029<\/a><\/p>

Lobo J, Gillis AJM, van den Berg A, Dorssers LCJ, Belge G, Dieckmann KP, Roest HP, van der Laan LJW, Gietema J, Hamilton RJ, Jer\u00f3nimo C, Henrique R, Salvatori D, Looijenga LHJ. 2019. Identification and Validation Model for Informative Liquid Biopsy-Based microRNA Biomarkers: Insights from Germ Cell Tumour In Vitro, In Vivo and Patient-Derived Data. Cells. 8: 1637. https:\/\/doi.org\/10.3390\/cells8121637<\/a><\/p>

Le\u00e3o R, Albersen M, Looijenga LHJ, Tandstad T, Kollmannsberger C, Murray MJ, Culine S, Coleman N, Belge G, Hamilton RJ, Dieckmann KP. 2021. Circulating MicroRNAs, the Next-Generation Serum Biomarkers in Testicular Germ Cell Tumours: A Systematic Review. Eur Urol. 80: 456-466. https:\/\/doi.org\/10.1016\/j.eururo.2021.06.006<\/a><\/p>

Syring I, Bartels J, Holdenrieder S, Kristiansen G, M\u00fcller SC, Ellinger J. 2015. Circulating serum miRNA (miR-367-3p, miR-371a-3p, miR-372-3p and miR-373-3p) as biomarkers in patients with testicular germ cell cancer. J Urol. 193: 331-337. https:\/\/doi.org\/10.1016\/j.juro.2014.07.010<\/a><\/p>

Radtke A, Hennig F, Ikogho R, Hammel J, Anheuser P, W\u00fclfing C, Belge G, Dieckmann KP. 2018. The Novel Biomarker of Germ Cell Tumours, Micro-RNA-371a-3p, Has a Very Rapid Decay in Patients with Clinical Stage 1. Urol Int. 100: 470-475. https:\/\/doi.org\/10.1159\/000488771<\/a><\/p>

Nazzani S, Busico A, Bernasconi V, Bruniera M, Giannin\u00f2 M, Rusconi D, Gualtieri J, Silvani C, Macchi A, Torelli T, Stagni S, Tesone A, Saitta C, Capone I, Cascella T, Lanocita R, Barella M, Paolini B, Perrone F, Albo G, Catanzaro MA, Biasoni D, Montanari E, Nicolai N; Italian Germ Cell Cancer Group. 2025. clinical evaluation of the role of miRNA 371 in small testicular masses. Results of the \"S1STeM 371\" Trial. Eur J Cancer. 223: 115494. https:\/\/doi.org\/10.1016\/j.ejca.2025.115494<\/a><\/p>

Fankhauser CD, Wettstein MS, Christiansen AJ, Rothermundt C, Cathomas R, Kaufmann E, Sigg S, Templeton AJ, Hirschi-Blickenstorfer A, Lorch A, Gillessen S, Beyer J, Hermanns T. 2024. Cut-offs for relapse detection in men with stage I testicular germ cell tumors during active surveillance within a prospective multicentre cohort study using either raw or housekeeper normalized miR-371a-3p serum levels. Urol Oncol. 42: 455.e9-455.e13. https:\/\/doi.org\/10.1016\/j.urolonc.2024.07.013<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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Specifications: What makes the M731 test special <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/i><\/span>\n\t\t\t<\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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What makes the M371-Test so special?<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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