Alongside Stirling Medical Innovations Ltd, a member of the Inverness Medical group of companies (IMI), we have developed a new immunoassay platform consisting of a consumable strip that carries a single use immunoassay and associated reagents and an analytical reader. The consumable strip provides a microfluidic reaction chamber that provides for direct application of sample without requirement for sample pre-treatment, which separates target analyte from complex or contaminated samples.

A core activity of the Cardiac Biomarkers programme, jointly funded by Scottish Enterprise and IMI, has been the development of a platform that is able to detect human cardiac biomarkers from patients when used within the home or point-of-care setting. IMI has a long established track record in the development of diagnostic assays for home or point-of-care use, as well as expertise in manufacturing processes which enable large volume manufacture of high sensitivity assays.

The platform, which is subject to clinical trials, is designed for at home or at point of care testing of medical conditions and IMI retains all rights to use of the technology in this arena. The system provides a generic immunoassay platform that can be tailored to support a wide range of other diagnostic applications. It is expected the technology will have utility in markets, including veterinary diagnostics, research, water testing, environmental monitoring and food testing, and Scottish Enterprise seeks licensing partners to exploit the assay technology in these areas.

Key benefits

• Capability to perform a rapid test (under 10 minutes for a ~12μl blood sample)
• Very low sample volumes (12μl blood, 2.5μl plasma)
• No sample pre-treatment required for a blood sample
• Ability to detect even in ‘dirty’ samples. The strip incorporates a technology that enables separation of the analyte of interest from the sample matrix, which significantly reduces the likelihood of the detection area being adversely affected by ‘contaminants’ within the matrix.
• Ability to detect 'complex' samples. The strip incorporates a technology that enables transfer of the analyte of interest out of the incubation area to a detection area, which greatly reduces the risk of interference.
• Potential for multi-assay. The technology could accommodate 3-4 separate simultaneous tests in its current format
• Potential for use in other liquid samples, and also gas and solid samples by adding a pre-sampling step
• Low cost
• Designed for ease of high volume process manufacture

Applications (subject to regulatory approval)

• Any immunoassay for diagnostic or analytical use outside the field of human healthcare
• Any market sector where decentralised testing (point of use) is beneficial
• Any application where high value small volume testing is required

Candidate markets are veterinary, food, water, environmental and biodefence.

Patent status

The technology platform is the subject of a number of patent applications relating primarily to strip design and the key proprietary magnetic bead separation. The technology aims to deliver high sensitivity detection of target analyte in low volumes of raw sample without requiring a sample pre-treatment step.

Meter features

The disposable microfluidics strip, which is at the heart of the platform is read by a stand-alone meter, incorporates a simple magnet on the bottom, used to perform the assay.

The main meter functionalities are:

• Gprs enabled
• User-friendly (designed for users with low finger mobility)
• Rechargeable battery
• Portable (size of a common wireless chip and pin terminal)

Commercial opportunity

We are seeking to license its rights to specific nonhuman healthcare applications of this platform to partners with the capability to enter one or more of these market sectors under its CBV program. Licensing partners are sought with expertise in this area and the capability to transpose their existing tests to the new platform, or development of new tests which exploit this platform.

We envisage several application area-specific licences to one or more partners able to exploit the unique technological capabilities of this platform and the economies of scale gained from co-production in the high volume medical sector.

The next step

If you’re interested in exploring this opportunity further, from either a research or commercialisation perspective, please contact us