White PaperMechanical & Fluid Systems
A Faster Route to Custom-Design Molecular Diagnostic Instruments
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This whitepaper delves into developing molecular diagnostics instruments, emphasizing the advantages of collaboration with experienced OEMs using platforms like Cavro® Omni Flex for efficient design and regulatory compliance. It highlights how such customizable and modular systems facilitate tailored solutions that meet specific laboratory needs, significantly reducing development cycles, enhancing diagnostic accuracy, and accelerating market deployment, all while maintaining high standards of reliability and efficiency.
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Overview
The white paper discusses the development of custom-designed molecular diagnostics instruments, emphasizing the importance of strategic planning and execution. It highlights the critical role of Original Equipment Manufacturer (OEM) partners, such as Tecan, in facilitating the development process. Companies must assess whether to utilize internal resources or collaborate with an experienced OEM developer, considering factors like cost, expertise, and time efficiency.
Molecular diagnostics is essential in modern healthcare, enabling the detection and measurement of DNA or RNA markers for disease diagnosis, pathogen identification, and patient health monitoring. The demand for high-throughput, state-of-the-art instruments is increasing due to technological advancements in this rapidly evolving field. Instruments must meet complex clinical research and diagnostic workflow requirements, ensuring reliable and accurate liquid handling of small sample volumes while minimizing cross-contamination risks.
The paper introduces the Cavro Omni Flex, a modular liquid handling platform designed to accelerate the development of fully automated molecular diagnostics solutions. This platform combines proven liquid handling performance with advanced process security and sample logistics options. Its modular design allows for customization based on specific assay needs, accommodating various requirements for size, speed, volume, and throughput. The Cavro Omni Flex can be integrated into different systems, enabling developers to focus on applications rather than individual pipetting tasks, thus shortening development cycles and reducing risks.
Additionally, the paper emphasizes the importance of compliance with quality standards, such as ISO 13485 and FDA regulations, to streamline regulatory approval processes. The Cavro Omni Flex is designed to meet these standards, ensuring that all components undergo comprehensive testing and validation.
The white paper concludes by underscoring the significance of OEM developers in the molecular diagnostics landscape. By partnering with experienced companies like Tecan, manufacturers can navigate the complexities of instrument development more efficiently, ultimately delivering cutting-edge diagnostic tools that enhance patient management and accelerate diagnoses in clinical laboratories. The collaboration between OEMs and manufacturers is portrayed as a vital strategy for success in the competitive field of molecular diagnostics.