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UK SME with fully automated molecular diagnostic device looks for partners in the life science sector

Country of Origin: United Kingdom
Reference Number: TOUK20210401001
Publication Date: 1 April 2021

Summary

Expert UK SME in the medical/healthcare sector offers innovative point-of-care (POC) technology to diagnose viral and bacterial infections within a fast and reliable process. The SME is looking to partner with a life science organisation, (R&D centre/academia/private for profit firm) to establish a research cooperation agreement  in which the partner will provide specifications for test performance and the SME will develop the prototype. In the long-term, commercial exploitation is envisaged.

Description

The SME is a medical diagnostics research, design, and development company based in the United Kingdom. With an expert research and development (R&D) team working in a state-of-the-art facility, they specialise in designing and developing fully automated molecular diagnostic devices from concept to prototype, including biological assays, electronics, microfluidics, and embedded software. 

The company was established in 2014 as a biotechnology R&D company for the development of antimicrobial solutions, and in the last 2 years has shifted its focus towards the development of point-of-care (POC) diagnostic systems, particularly targeting infectious diseases.

The company’s main driver for POC device development was to empower clinicians in primary care by providing a fast, reliable, and accurate tool for the diagnosis of viral and bacterial infections. POC testing for infectious diseases such as respiratory infections have been shown to, not only improve patient outcome, but also reduce unnecessary antibiotic prescriptions, thus reducing the emergence of antimicrobial resistance (AMR). AMR is recognised as a global medical emergency that threatens the efficacy of antibiotics against bacterial infections.

Current microbiological tests involve sending samples to a laboratory and waiting several days for results of bacterial culture and identification to be returned to the clinician. This easy-to-use POC device consolidates all aspects of laboratory-based molecular testing from sample processing to data analysis, providing reliable results, in the clinic, within 30 minutes after sample collection and initial analysis.

The universal design features of the device and the disposable cartridge allow for a fully customisable single-sample molecular test with up to five different assays performed simultaneously.

The main use is related to clinicians. However, the device and cartridge can be adapted for specific applications relevant to:
- Veterinary science
- Agriculture
- Food safety
- Pharmaceutical industry

The expected outcome of the research cooperation is to produce a POC diagnostic device that can accurately and rapidly detect viral and bacterial infections.

The SME is looking to establish a research cooperation agreement with R&D centres, academia or private for profit firms in which the partner(s) will provide specifications for test performance and the UK SME will develop the prototype. In the long-term, commercial exploitation is envisaged.

Advantages and Innovations

The gold standard for molecular diagnostic assays is polymerase chain reaction (PCR). PCR is usually performed in the laboratory and requires expensive and bulky laboratory equipment to process and test samples, in addition to trained staff for operating the equipment and performing the tests. Nowadays PCR technology is commonly related to Covid-19 detection, however, the technology is used beyond Covid-19. 

The SMEs innovative cartridge accurately separates the patient sample into microlitre volumes that activate pre-loaded reaction components. All required material, apart from the patient sample, enclosed within the cartridge are released and mixed using smart microfluidic technology. The fully integrated cartridge format precludes the need for specialised training, additional equipment, or lab consumables.

While PCR takes on average 4 hours from sample receipt to test result, the company’s technology has a sample-to-result turnaround time of 30 minutes, with some positive results reported after just 10 minutes.

Stage Of Development

Prototype available for demonstration

Requested partner

The SME is looking to partner with life science organisations, (R&D centre, academia or private for profit firm). Ideally, the organisation would be developing or has developed its own biological assay(s) and is seeking to bring it to the point of care or point of need, in a fully automated testing platform. The assay might require sensitive temperature controls, fluid manipulation, and/or optical detection such as fluorescence / chemiluminescence.

The research cooperation agreement between the SME and the partner will result in a POC diagnostic device that can accurately and rapidly detect the targets or biomarkers for which the assay was developed. The partner will provide specifications for test performance, materials, and instructions and the SME will produce a fully functional prototype that can be used for preliminary clinical or field testing. Contingent on satisfactory results, the SME and partner could then enter into a commercial agreement. This second phase would enable both parties to focus on mass manufacturing and commercialisation of the product.

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