License Proven CASA Technology for Human Diagnostics

Field-validated in veterinary applications with 30,000+ tests. Defined regulatory pathway for human fertility diagnostics.

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Ongo Vision device analyzing a sample, connected to tablet showing live CASA microscopy

At a Glance

30,000+

Veterinary tests performed

Up to 85%

Cost reduction vs conventional laboratory CASA

11

Semen analysis devices cleared by FDA

Regulatory Pathway

EU — IVDR

Classification
Class B, Rule 3
Basis
Independent professional regulatory assessment
Requirements
Notified Body assessment, ISO 13485 QMS, clinical performance study
Status
Pathway defined, regulatory roadmap and clinical study design available

US — FDA

Classification
Class II, 510(k)
Product code
POV (Semen analysis device)
Predicates
11 cleared devices across 4 manufacturers
Portable precedent
Yes — smartphone-based and compact CASA devices cleared

Professional regulatory roadmap and clinical study design available for review.

Licensing Package

Patent Portfolio

  • US and EU patents granted through 2038
  • Coverage: 20 European countries + United States
  • Hardware platform design (optics, electronics, mechanical layout)

Hardware & Manufacturing

  • Complete design package: optics, electronics, firmware
  • Established manufacturing process with documented workflows
  • Documented supplier relationships and production workflow

Regulatory Assets

  • IVDR regulatory roadmap from independent consultancy
  • Clinical performance study design with statistical methodology and cost framework
  • Existing CE marking documentation (LVD, EMC)

Technical Support

  • Engineering support during technology transfer
  • Manufacturing guidance and quality documentation
  • Species-specific analysis algorithm documentation

Beyond Veterinary CASA

The same patented hardware platform supports applications beyond animal breeding — expanding the addressable market for a licensee.

Male Health Screening

Emerging clinical research links semen parameters to broader male health indicators. Point-of-care analysis enables screening outside the fertility clinic.

Treatment Monitoring

Pre- and post-treatment semen analysis for fertility clinics. Repeat testing at point of care instead of returning to the lab.

Research & Clinical Trials

Low-cost CASA for multi-site reproductive research. Portable form factor enables decentralized study designs.

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Common Questions

What is CASA technology?

Computer-Assisted Sperm Analysis (CASA) automates the measurement of sperm concentration, motility, and kinematics parameters. YScope brings CASA from the laboratory to the point of care using a portable, handheld device.

How does YScope compare to manual semen analysis?

Manual analysis is subjective and operator-dependent, with significant inter-observer variability. YScope provides automated, standardized measurements with objective sperm kinematics data — concentration, total motility, and progressive motility — in 30–50 seconds.

Is YScope designed for WHO-compliant analysis?

The underlying CASA platform measures the parameters defined in WHO semen analysis guidelines. Formal WHO compliance validation is part of the regulatory pathway and has not yet been completed.

Can YScope integrate with laboratory information systems?

Data exports in CSV and PDF formats are available. Integration with specific LIMS systems would be part of the licensing and development process with the technology partner.

Know a diagnostic company that should see this? We welcome introductions.

YScope — License CASA Technology for Human Diagnostics