Immunoassay Diagnostics & Point-of-Care (PoC) Device Development

The Situation: Accelerating Low-Cost Diagnostic Innovation

An Asian diagnostic device developer appointed Dr Lee Smith as interim CEO to lead the end-to-end development of a low-cost, point-of-care (PoC) immunotesting platform. The project required a unique combination of technical specialist assay development and strategic commercialisation to prepare a disposable, credit-card-sized test card and reading device for regulatory approval and international partnering.

GRA Involvement: Technical & Strategic Oversight

GRA provided hands-on leadership across the entire product development lifecycle, ensuring every milestone met rigorous clinical and commercial standards:

Market Review & Bio-marker Selection: Identifying high-value clinical targets and commercial gaps.
Device Design & Engineering: Directing the development of the hardware and disposable card architecture.
IP Strategy & Patent Filings: Securing the intellectual property foundations for the platform.
Specialist Assay Development & QC: Engineering the immunoassays within the microfluidic card environment.
Product Marketing & Global Partnering: Positioning the technology for acquisition or licensing.

Value Added: Accelerating Time-to-Market and Securing IP

GRA successfully transformed a development project into a commercially viable platform, delivering the following key results:

Validated Commercial Opportunity: Assessed the market and designed a device based on market needs, maximising its potential commercial value.
Secured Core IP: Successfully filed key patents for the device technology.
Rapid Assay Integration: Developed and integrated three crucial immunoassays (CK, MB, TnI) into the credit-card-sized test card.
High-Profile Launch: Led the device's successful launch at a major industry event, the American Association of Clinical Chemistry (AACC) in Atlanta, USA, 2012.
Partnership Pipeline Established: Identified and engaged multiple potential international partners interested in licensing and adopting the technology platform.