Wayne Biotech brings a unique molecular diagnostics platform that offers rapid and highly precise results without the need for complex laboratory infrastructure. Our patented technology enables real-time detection of infectious diseases across human, animals and environment.
Our platform is designed to deliver accurate, actionable results without the need for complex laboratory infrastructure.
Rapid results: in less than 90 minutes from sample to answer.
Direct detection: no need for additional testing.
Multiplex: capacity to develop panels.
To ensure traceability, reliability, and consistent performance across our distribution network, Wayne Biotech operates a multi-layer quality and oversight framework. We work with carefully selected partners under clearly defined standards and continuous monitoring.
Scientific Supervision
Our internal scientific team oversees assay design, validation strategy, and ongoing performance monitoring for all diagnostic kits and devices.
Manufacturing
Kits are produced by Certest, a GMP-compliant / ISO 13485 certified manufacturing partner, under Wayne Biotech’s specifications and quality agreements.
Quality Control & Certifications
Each lot follows predefined quality control protocols before release to distribution partners.
System architecture, firmware, and software are designed to support reliable assay performance and secure data handling.
Hardware and software are developed to comply with relevant standards such as IEC 61010, IEC 62304, ISO 14971, and are validated by independent bodies where required.
Hardware & Software Development
Client relations and distribution partnerships are managed by a team experienced in diagnostics, market development, and long-term channel management.
Transparent agreements
Distribution agreements clearly define responsibilities for storage, handling, traceability, and pharmacovigilance / vigilance reporting (use the correct term for your regulatory domain).
Ongoing monitoring
We monitor distributor performance through periodic reviews, audits where appropriate, and defined KPIs for quality and service.
Regulatory alignment
Contracts are aligned with applicable regulations in each market, including requirements for reporting and corrective actions.