Building the future of oncology monitoring

Testicular cancer affects more than 70,000men globally each year, most commonly between ages 20 and 45. While cure ratesare high, up to half of patients experience relapse and require years offollow-up through repeated CT scans, exposing them to radiation, contrastagents, and significant clinical burden.

mir|detect offers a safer alternative. Led byCEO & Founder Dr. Nina Winter, the company developed the firstCE-approved (IVDR) microRNA blood test for testicular cancer detection andrelapse monitoring, providing a radiation-free method that integratesseamlessly into standard laboratory workflows.

We spoke with Dr. Winter about the science behind the platform, its clinical impact, and what lies ahead for mir|detect.
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1. mir|detect developed the first CE-approved (IVDR) microRNA blood test for testicular cancer. What clinical gap were you aiming to address when founding the company?

When we founded mir|detect, the clinical gap was clear. Testicular cancer affects mainly young men, and while overall survival is high, up to half of all patients experience a recurrence. Follow-up care is therefore critical. Yet the tools available to clinicians were insufficient. Traditional serum markers such as AFP, β-hCG, and LDH offer sensitivities of only around 50 %, so they are close to a coin toss. This creates uncertainty in both initial diagnosis and surveillance, often leading to delayed decisions, incorrect assumptions about disease status leading to unnecessary surgeries, and avoidable imaging such as CT scans, with additional cost and radiation exposure.

We wanted to close this gap with a highly accurate, non-invasive, and affordable blood test that could reliably support both diagnosis and long-term monitoring. That goal ultimately led to the development of the first CE-approved (IVDR) microRNA test for testicular cancer.

‍2. Despite high cure rates, monitoring testicular cancer remains challenging. How does mir|detect improve the follow-up process compared with traditional CT-based protocols?

The M371-Test improves follow-up by shifting testicular cancer monitoring from imaging-heavy schedules to blood-test based care. Traditional protocols rely on CT scans plus the serum tumor markers AFP,β-hCG and LDH. These markers have low sensitivity and miss many relapses. Repeated CT scans expose young men to cumulative radiation, and small or unclear findings often lead to additional scans or even surgery without real diagnostic gain.

Using the M371-Test changes the follow-up strategy. Patients can be monitored with a fast, non-invasive blood test, and CT scans are reserved for situations where the M371-Test result or the clinical picture suggests real risk. This means fewer routine scans, less radiation, fewer unnecessary interventions and earlier treatment when a true relapse develops. CT remains important for staging and planning, but is used more selectively, guided by M371-Test results instead of fixed imaging intervals.

3. Your test integrates directly into standard laboratory workflows. What does this mean for clinicians and pathology labs in terms of adoption and efficiency?

The M371-Test fits into the workflows diagnostic labs already use for other qPCR assays, which are far more present since the pandemic, and uses familiar steps: RNA extraction, PCR setup and run, and reporting. Staff work with a standardized protocol instead of building an in-house solution, which under IVDR comes with higher regulatory requirements. This reduces validation effort, training time, and documentation. Labs can batch samples, use existing miRNA extraction platforms, and input results to their LIMS like any other qPCR assay. No new analyzer, no separate workflow, and no special infrastructure.

For clinicians, this translates into simple adoption. They order the test like other blood-based markers, rely one stablished logistics between hospital or practice and the lab, and receive a clear, quantitative report that fits into current tumor board and follow-up pathways. Turnaround times stay short, because the test uses processes the lab already controls at scale. In practice, this makes it easier to add miR-371a-3ptesting to routine care instead of setting up a parallel, experimental process.

4. The proprietary panta|Q technology underpins your microRNA test and future liquid biopsy developments. What makes this platform unique in terms of sensitivity and reliability?

panta|Q technology is a dedicated preamplification system with a unique protocol. Preamplification itself is not new, but standard setups are prone to operator-dependent variability and fluctuating reaction efficiencies. This is a major issue for novel nucleic acid biomarkers in liquid biopsies, which are present at very low concentrations and already push conventional PCR techniques to (and beyond) their limits. Some IVD manufacturers have moved toward next-generation sequencing to reach the needed sensitivity. NGS can detect these low-level signals, but current methods still lack the reliability expected in routine IVD use, generate massive datasets that require expert bioinformatics, and do not provide the clear, binary outcomes clinicians prefer.

panta|Q solves these problems. It enables ultrasensitive nucleic acid detection in routine clinical samples while the workflow remains simple and fully compatible with standard qPCR instruments. Results are easy to interpret, and trained lab technicians can run panta|Q assays quickly and reliably. In benchmarking studies, panta|Q reduced measurement variability by up to 88 percent and improved sensitivity, especially in low-signal samples where conventional methods often fail. This combination of strong signal amplification, low variability, and straightforward handling makes panta|Q well suited for liquid biopsy applications in oncology, infectious diseases, and other settings that require precise measurement of scarce nucleic acids. mir|detect holds freedom to operate for panta|Q and is actively managing the patent lifecycle to secure long-term protection of the technology.

5. mir|detect received FDA Breakthrough Device Designation and holds broad patent coverage. How do these validations strengthen your global expansion strategy?

The FDA Breakthrough Device Designation is a strong clinical and regulatory signal. It confirms that the M371-Test addresses a clear unmet need in a critical clinical setting where patient outcomes depend on timely and accurate decisions, and that our early data supports a faster and more structured route to US approval. This sharpens our clinical development plan, makes it easier to engage leading US centers and potential lab partners, and strengthens discussions with payers and guideline bodies who rely on this kind of external validation, which in turn reduces regulatory and market-entry risk in the United States.

Our broad patent coverage gives us room to build on this momentum. It protects our core panta|Q technology and theM371-Test concept, so we can invest in new indications and regional launches with a long planning horizon. It also makes us a more attractive strategic partner, because laboratories, distributors, and industry players can license our technology and develop their own offerings around our assays on a secure IP basis.

6. You’re preparing a plasma-based version for 2026. What additional clinical or operational benefits will this new format unlock?

A plasma-based version of the M371-Test will address a key operational hurdle of the current serum format. Serum requires rapid processing and frozen shipment, which many physicians outside of hospital settings cannot integrate into their daily workflows.

With plasma, processing can take place up to two days after the sample is taken. Physicians can send whole blood in standard collection tubes at room temperature, without immediate centrifugation and without frozen logistics. This makes the test far easier to use in outpatient settings.

Although the study is still running, the data collected so far shows the same strong performance of the M371-Test in plasma as in serum. At the same time, the tested microRNAs remain stable for up to 48 hours at 30 °C, which reduces pre-analytical risk and improves sample robustness.

In short, the plasma format unlocks broader clinical accessibility, simpler workflows, and a much more practical path to widespread use of theM371-Test starting in 2026.

7. Beyond testicular cancer, you’re advancing liquid biopsy tests for additional indications. Which areas do you see as most promising for the company’s pipeline?

Beyond testicular cancer, we see the strongest near-term potential in urological cancers, where the medical need is high and we already have a strong clinical network. We currently started the development for three urological cancers:

·     Prostate cancer

·     Bladder cancer

·     Renal cancer

In prostate cancer, PSA and imaging often fail to clearly separate indolent from aggressive disease, so a blood-based nucleic acid test could support risk stratification, biopsy decisions, and treatment monitoring. In bladder cancer, patients face frequent, invasive cystoscopies and high follow-up costs, so a reliable liquid biopsy could reduce procedures and provide earlier signals of recurrence. In renal cancer, there is still no widely used blood biomarker for diagnosis or follow-up, so a sensitive nucleic acid assay could enable earlier detection and more precise monitoring. Current tools in all three areas leave clear diagnostic gaps, and clinicians are asking for more objective, easy-to-use markers.

Beyond urology, we are also evaluating indications such as pancreatic cancer or cardiovascular disease, where outcomes depend heavily on earlier detection and better monitoring. Here, we will only advance programs where both the underlying nucleic acid biology and the path to clinical adoption are convincing.

8. mir|detect collaborates with oncologists, urologists, and distributors across Europe. What has the response been so far from your clinical partners?

Overall, the response has been overwhelmingly positive. Key opinion leaders appreciate that the M371-Testintegrates into existing workflows, provides a clear binary result, and supports decision making in situations where conventional serum markers are often uninformative. Many centers now use the test in routine practice for primary diagnosis and follow-up of testicular cancer, and several have told us that it is already influencing patient management.

At the same time, our key opinion leaders ask for broader reimbursement and inclusion in national and international guidelines.

While market approval for IVDs is granted at the European level, reimbursement decisions are still made nationally and often require country-specific data before they can be finalized. Here we work closely with our distribution partners in each country to drive national reimbursement. Guideline inclusion is equally important for broad adoption of the M371-Test. Many of our clinical partners see the growing body of evidence and are actively advocating for recommendations on miR-371a-3p. For the European EAU guideline and the German S3 guideline, we expect stronger representation of miR-371a-3p from2026 onwards.

9. As you enter your next scaling phase, what are the primary strategic priorities for mir|detect in 2026 and beyond?

Our strategic priorities are clear. With the M371-Test as the flagship product of mir|detect and inclusion in the German reimbursement system insight, we are well positioned to expand our portfolio and establish ourselves as a leading innovator in advanced nucleic acid diagnostics.

For the M371-Test, the next steps are entry into additional nationalreimbursement schemes and access to the US market, where a clinical study isstill required for approval. Both paths depend on strong regional partners whocan support study execution, reimbursement processes, and local adoption.

By partnering with experienced distributors for market access and distribution of the M371-Test, we can focus our internal resources on developing and validating new diagnostic solutions. Going forward, we will use our panta|Q technology to build a broader IVD portfolio, potentially also in collaboration with a strategic partner. Our first focus will be urological cancers with clear unmet medical need, such as prostate, renal, and bladder cancer, where we can build on our existing expertise and key opinion leader network.

Explore the opportunity.