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Epigem successfully develops prototypes for Johne’s disease & TB detection

Epigem today announced a successful, newly designed portable, prototype instrument for diagnosis of Johne’s disease in cattle and TB in both humans and cattle.

The company is now focused on the next stage of preparing the instrument for extensive operational trials following the completion of two Innovate UK funded projects, MilkED and MIMIC.

This will demonstrate the benefits to end users and determine the most effective exploitation route.

 

MilkED

The key achievement in MilkED was the identification of a viable route to manufacture of an instrument which can detect Johne’s disease in less than 45 mins from cow faeces. The instrument had to work not only in a laboratory but also on the farm.

It uses surface acoustic waves to control an assay, packaged into a disposable cassette. This cassette interconnects in a ‘plug and play’ manner within a boxed data reader, and is fully automated.

The portable reader comprises a set of integrated, miniaturised sub-assemblies performing electro-optical, microfluidic and microelectronic functions, operated by a microcomputer automatically. The test is based on a polymerase chain reaction (PCR) in a miniaturised environment, and the 45 minutes includes extraction time.

Johne’s disease significantly reduces milk production and herd well-being, and is a dilemma for the industry. The pathogen causing Johne’s disease, Mycobacterium avium subspecies paratuberculosis, infects cattle and other ruminants, causing chronic diarrhoea, emaciation, and often death. In addition to the detrimental impact on the health of herds, it may be present in milk and resists pasteurisation.

The MilkED industrial research programme is business led by manufacturer Epigem, working in partnership with animal welfare company Enfer Scientific in collaboration with the University of Glasgow and its spin-out company SAW Dx Ltd.

 

MIMIC

MIMIC shares the same partners as MilkED, and adds clinical expertise. It aims to diagnose tuberculosis (TB) in humans, based on a blood sample from a finger-prick in a matter of minutes. It assembled a business-led consortium with a wide range of expertise, from clinical TB experts caring for patients at three different University Hospitals across the UK, to engineering and biology specialists.

Epigem has adapted the portable prototype, again with a disposable cassette, which performs serology this time. This assay can be used to detect human TB and the instrument can test the target sample volume of a drop of blood in less than 20 minutes.

A cohort of over 900 people were tested as part of the project, using a library of more than 40 different mycobacterial antigens to identify TB-specific antibodies. The project identified a range of antibodies in the blood of TB patients. The final data analysis is currently in progress, but an interim analysis suggests that a multiplexed assay combining a range of antibodies can easily achieve sensitivity and specificity values in excess of 80%. Because of the speed of the device, it has potential for use as a triage test especially in areas with a high TB incidence.

The results of the project are also relevant to TB in cattle and similar diseases in other animals.

The clinical expertise was provided by Dr Steve Morris-Jones of University College London Hospitals, Dr Marc Tebruegge of University Hospital Southampton and Dr Adam Hill of the Edinburgh Royal Infirmary.

With one third1 of the world’s population currently infected with TB and more than eight million new cases of active TB every year, rapid diagnosis of TB can significantly aid patient management and prevent the infection spreading through the community.

 

Tim Ryan, Epigem’s managing director, said: “We have made great strides technically in manufacturing devices to detect Johne’s disease in cattle and TB in humans. Complex problems require excellent multi-disciplinary teamwork, and these projects confirm that. The combination of PCR and serology is currently the best solution we can offer.”

“Epigem aims to play a leading role in the further development and commercialisation of these devices, and will encourage further research into understanding infectious diseases more broadly. They fit our overall strategy in providing healthcare solutions.”

Professor Jon Cooper, Vice Principal for Knowledge Exchange and Innovation at the University of Glasgow, and whose research team was involved in the technical delivery of aspects of the microfluidics and diagnostic instrumentation in these grants, said: “The two projects are clear beacons of excellence in innovation – showing how teams of engineers, scientists and clinicians from industry, the NHS and academia can work together to deliver new products.

“The sensors potentially have significant impact in both the veterinary and clinical markets, here in the UK and globally.”

Dr Marc Tebruegge, now based at the Evelina London Children’s Hospital, Guy’s and St. Thomas NHS Foundation Trust, and the UCL Great Ormond Street Institute for Child Health, who was the Clinical Lead of the project, said: “Existing diagnostic methods for TB have significant limitations, and are generally poorly suited for use in high TB incidence, low resource settings.

“The project has shown that multiplexed, antibody-based tests for TB are potentially feasible. The advantage of antibody-based tests is that they are typically very robust, can produce results rapidly and can be produced at relatively low cost. All those characteristics would make them ideal tools to tackle the ongoing global TB pandemic.”

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