To deliver its home-to-lab semen analysis, Malebox has partnered with Hurdle, a company in diagnostic infrastructure and technology. Hurdle provides the platform and expertise to support the development, validation, and deployment of high-quality diagnostics at scale, integrating clinical, molecular, and real-world data to drive precision and reliability. Through this collaboration, Malebox ensures its testing kits meet the highest standards of clinical accuracy and scalability.

Male infertility is often overlooked in reproductive health discussions, despite contributing to up to 50% of infertility cases worldwide. Sperm counts have halved in the past 50 years in the Western World, with the rate of decline accelerating. Environmental factors, lifestyle choices, and stress are among the key drivers of this trend.  Despite these alarming statistics, male fertility testing remains underutilised, with much of the investigative burden falling on women.

Traditionally male fertility testing has relied on in-clinic semen analysis, a process associated with inconvenience, discomfort, and embarrassment for the man. These barriers frequently result in delayed or avoided testing, leaving many fertility issues unaddressed.

In-person semen analysis also poses significant logistical challenges for clinics. Traditionally, samples must be analysed by specialist professionals within 1 hour of production. Meaning that facilities for men to produce samples must be co-located with laboratories and staffed to enable rapid turnaround of analysis.

Malebox has developed an advanced home-to-lab semen analysis kit to overcome these challenges. The system consists of two key components:

• Malebox Postal Kit: a user-friendly collection system that enables patients to collect and preserve their semen sample discreetly at home
• Malebox Predictive Models: proprietary predictive models, developed using thousands of paired data points, that account for the complex sample aging process caused during transport, ensuring results remain consistent with in-clinic analyses

Together, these innovations allow clinicians to offer accurate fertility testing while reducing and eliminating logistical and geographical hurdles for both patients and medical staff.

Malebox’s innovative home-to-lab semen analysis kits have undergone rigorous clinical performance assessment as well as risk and usability testing to achieve medical device registration (UKCA IVD). Our analyses are performed by registered clinicians to ensure quality and identification of abnormalities or inconsistencies.

Malebox provides several important advantages over traditional fertility testing methods and other at-home male fertility tests:

• Enhanced Access: patients can complete testing at home, eliminating barriers related to location, time, or stigma and encouraging greater participation in fertility assessments
• Streamlined Workflow: for clinicians, Malebox simplifies the diagnostic process by removing the need for on-site sample collection
• Early Intervention: reduced barriers and convenience enable earlier testing and identification of potential issues
• Comprehensive and accurate results: full semen analysis results with validated performance within the accepted variation of in-person semen analysis (WHO Semen Analysis guidelines 6th Edition)

Malebox represents a major step forward in male fertility testing, combining convenience and clinical precision and expertise. By addressing the limitations of traditional methods and adopting a responsible and rigorous approach to testing, Malebox empowers clinicians with detailed insights while providing patients with a discreet, accessible testing solution. Through its collaboration with Hurdle, Malebox ensures that its home-to-lab testing is built on a foundation of robust validation, clinical-grade analysis, and scalable diagnostic innovation.

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