The Lumos Assay Development Team has broad experience over a wide range of assays, configurations and specimen types.
Lumos assay development follows a development-phased approach, with a focus on reducing project and product risk and matches the development effort with y your business requirements.
Approach: Lumos works collaboratively with our partners, bringing a wealth of product development expertise and market knowledge combined with a flexible approach. Lumos begins by obtaining a thorough understanding of the customer and product needs, ensuring the key specifications and design elements are fully understood from both a scientific and market perspective. Any existing partner reagents, platforms and R&D information is considered prior to formulating a recommended path forward.
Process: Lumos employs a phased, risk-based approach to product development. Our team is experienced across the range of development phases, guiding your product seamlessly from feasibility through to verification, validation and design transfer into manufacturing. The Lumos development and manufacturing teams are co-located ensuring a timely and seamless transition.
Throughout the development program, our experienced Project Management Office will ensure clear communication of project progress and tracking against timelines and budget.
Platforms: Lumos leverages its existing gold-standard assay chemistry methods and digital reader platforms to expedite timelines, minimize costs and mitigate product risks to accelerate time to market. Our in-house assay development Centers of Excellence program evaluates novel chemistries and materials, ensuring we start with a near optimal configuration for a product needs.
Lumos initiates each project by collaborating closely with its partners to gain a comprehensive understanding of both the customer's needs and the prevailing market dynamics. Employing established methodologies for market assessment and defining end-user requirements, we discern the optimal solution for our partners. This approach may entail on-site visits to laboratories and clinics, enabling us to gain valuable insights into the operational environment.
Our profound comprehension of the market intricacies informs our development process, ensuring that customer needs remain central at every stage. Adhering to a standardized phased approach, we leverage our established optical technologies, data analytics, and cloud infrastructure to expedite timelines, minimize costs, and mitigate product risks, thereby accelerating time-to-market.
With our complete in-house development team, we effectively streamline the parallel progression of individual components within a Proof of Concept POC diagnostic system. This capability is crucial in delivering the highest quality product within specified timelines.
Lumos possesses the expertise to guide your product seamlessly through verification, validation, and manufacturing stages, while adhering to FDA and ISO compliant processes as required according to your product and business requirements.
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