Written by: Aonghus Topham
Edited by: Lucy Ahern
Company: Virilitas Labs
Location: Norwich, UK
Founded: 2022
Founders Daniel Marcu & Simone Immler
1 in 6 couples face infertility[1], yet male fertility remains underexplored and undertested. Infertility, defined as a failure to achieve pregnancy after ≥12 months of regular unprotected sexual intercourse, poses a significant financial and mental health burden worldwide[1]. Despite contributing to around 50% of cases, men are often tested late in the diagnostic pathway, typically after extensive female investigation. This delay reflects a system that is slow, clinic-based, and not designed for early or accessible male assessment.
Unlike many global health challenges, infertility impacts people across geography and income, highlighting the need for scalable and accessible solutions. With over 20 years of expertise in reproductive biology and genetics, Virilitas Labs is on a mission to transform how male fertility is tested, monitored, and understood.
Male reproductive health has long been overshadowed in discussions of fertility, yet it accounts for half of all infertility cases worldwide[2,3], and has increased in prevalence over the last 20+ years[4]. Despite this, innovation in diagnostics has lagged behind other areas of medicine. While many fields have transitioned from manual techniques to automated, standardised technologies, male fertility testing remains largely reliant on outdated, operator-dependent methods. Semen analysis, the current clinical standard, is limited in scope and accessibility. It is typically performed in specialised laboratories and requires trained personnel. This creates variability in results and delays in diagnosis, limiting its effectiveness as a frontline tool for early detection.
In response to the limitations of clinic-based testing, a range of at-home solutions have emerged, broadly falling into two categories: rapid at-home tests and home-to-laboratory services. While both aim to improve accessibility and privacy, each comes with significant limitations that prevent them from effectively addressing the problem. Rapid at-home tests offer convenience and immediacy but are fundamentally limited in their clinical value. Most measure only a single parameter, typically sperm concentration. This narrow scope fails to reflect the complexity of male fertility, which depends on multiple interacting factors. As a result, these tests often provide an incomplete and potentially misleading picture of reproductive health, offering little guidance on next steps.
Home-to-laboratory services attempt to bridge this gap by enabling users to collect samples at home and send them to a central lab for analysis. While this approach can provide more comprehensive data, it introduces a different set of challenges. Sample degradation during transport, variability in handling, and delays between collection and analysis can all impact result accuracy. In addition, these services remain episodic, expensive, and slow, often taking several days to return results. This limits their usefulness for continuous monitoring and does little to encourage early or repeated engagement with fertility testing.
Across both models, a key issue persists: results are rarely integrated into a clear clinical pathway. Whether limited in scope or delayed in delivery, the outputs often lack the context and standardisation required to support meaningful clinical decision-making. This creates a fragmented diagnostic landscape where patients either receive fast but superficial insights or more detailed information that is slow, costly, and difficult to act upon.
At the same time, declining sperm counts, delayed parenthood, and increased environmental exposures are driving greater demand for earlier and more frequent fertility assessment. Taken together, these challenges highlight a clear gap in the current model of care. There is a growing need for diagnostic solutions that combine the accessibility of at-home testing with the depth, reliability, and clinical relevance required to meaningfully assess male fertility.
Founded in 2022 at the University of East Anglia by Professor Simone Immler (Professor of Genetics and Reproduction) and Dr Daniel Marcu (Senior Research Scientist), Virilitas Labs is built on deep expertise in reproductive biology and genetics. Daniel Marcu’s path toward Virilitas Labs began following his MSc in Prenatal Genetics and Fetal Medicine at University College London. He later undertook research at the Francis Crick Institute, where he saw first-hand how sperm biology remained significantly underexplored. This led him to pursue a PhD in sperm biology and genomics under Professor Simone Immler, focusing on sperm function and genomics. He co-founded Virilitas alongside Professor Immler, who leads a research group at the University of East Anglia and has pioneered the use of multi-omics approaches to uncover fundamental sperm biology processes, supported by major international funding and publications.
Virilitas Labs is focused on transforming how male fertility is tested and understood by addressing a critical gap in the current diagnostic pathway, where men are often tested late and with limited insight. The company is developing an at-home fertility test designed to provide a more complete and accessible assessment of male reproductive health. Unlike existing solutions that offer only partial or basic results, Virilitas enables a broader evaluation of key fertility markers in a single test, giving a clearer and more meaningful picture of men’s reproductive health and fertility.
The platform combines enzymatic testing technology with smartphone-based analysis, using computer vision and AI to deliver fast, standardised interpretation of results. This removes much of the variability, delay, and subjectivity associated with traditional testing, while maintaining ease of use at home.
By shifting testing out of the clinic and into the home, Virilitas enables earlier engagement with male reproductive health and supports more informed clinical decision-making. Rather than replacing clinical pathways, it strengthens them by providing higher-quality data before patients enter the healthcare system. Since its founding, the company has focused on translating its scientific expertise into a scalable diagnostic solution. A working prototype has been developed, supported by non-dilutive funding, early investment, and strategic partnerships. Virilitas is now progressing toward a minimum viable product (MVP), with plans for launch in the near term.
The global male infertility market is projected to grow from $4.2 billion in 2023 to approximately $5.9 billion by 2030[5], driven by rising infertility rates and demand for more accessible solutions. As existing approaches continue to delay diagnosis and limit insight, Virilitas is positioned to play a key role in reshaping male reproductive care by enabling earlier, more informed decision-making.
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