Assay Development

Our experienced assay team manages the full development program for diagnostic tests, from sourcing and/or generation of reagents, right through to verification, validation and design transfer.

We bring over 30 years of experience in assay development and widespread knowledge of the diagnostic testing market.

Full Assay Development Capabilities

  • Antibody design and development for small molecules through to proteins
  • Immunoassay test development using lateral flow, ELISA and novel point-of-care (POC), microfluidic and sensor platforms
  • Detection of nucleic acids and amplification products
  • Translation of bench protocols onto diagnostic devices
  • Conjugation to a range of visible and fluorescent detection chemistries
  • Qualitative, semi-quantitative and quantitative formats
  • Single and multi-analyte assay configurations
  • Broad range of specimen types, including human, veterinary and environmental
  • In-house OEM manufacturing of reagents, test consumables and kits
How we do it

End-to-End Assay Development Process

Lumos assay development follows a phased approach, with a focus on reducing project and product risk while matching the development effort with your business requirements. Lumos works collaboratively with our partners, bringing a wealth of product development expertise across a range of assay types and platforms, combined with a flexible approach.

Phase 0 - Product Definition & Planning

Lumos begins by obtaining a thorough understanding of the customer and product needs, ensuring the key specifications and design elements are fully understood from a scientific and market perspective. Any existing partner reagents, platform, and other relevant information is considered prior to formulating a recommended path forward.

Phase 1 - Feasibility

The initial technical program will focus on building up the core components of the assay in a stepwise approach. Our assay development team is experienced in reagent design, conjugation chemistry, and formulation to maximize stability in liquid, dried and lyophilized formats.

Phase 2 - Development

Assay maturity is progressed to the final format with real samples, evaluating performance to key requirements along the way and optimizing as required. Pilot product builds and pre-verification studies are performed to reduce risk for subsequent formal testing phases.

Phase 3 - Verification & Initiate Design Transfer

Formal Verification studies are conducted, tailored to meet relevant regulatory, industry body and business needs. Raw material specification, assay formulations and methods and quality control procedures are translated into formal manufacturing documents. Manufacturing process validation is conducted either internally at Lumos or external providers.

Phase 4 - Validation & Complete Design Transfer

Assay cartridges are manufactured to ISO 13485 ready for formal studies required for regulatory clearance or approval.

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 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.

Contact us to learn more about Lumos Services

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