Mofina

Mobile Filovirus Nucleic Acid Test

FACTS & FIGURES

Start Date
End Date
Call
IMI2 - Call 2
Grant agreement number
115848

Contributions
IMI Funding
1 162 622
EFPIA in kind
0
Other
3 235 630
Total Cost4 398 252

Summary

The Mofina project is developing a new diagnostic test that will deliver results in under 45 minutes on whether the patient has Ebola or a related disease such as Marburg virus. Crucially, the device is designed to work well in sites where high-end laboratory infrastructures are simply not available, while also protecting users from infection.

Rapid diagnostic tests

There is an urgent need for fast, reliable tests to determine if someone is infected with Ebola or not. Three projects , Mofina,  FILODIAG and  EbolaMoDRAD, will pave the way for rapid diagnostic tests capable of delivering reliable results at the point of care in as little as 15 minutes.

The Mofina project will develop a new diagnostic test that will deliver results in under 45 minutes on whether the patient has Ebola or a related disease such as Marburg virus. Crucially, the device is designed to work well in sites where high-end laboratory infrastructures are simply not available, while also protecting users from infection. The project will draw on two existing technologies: a conventional Ebola virus test, and a point-of-care molecular diagnostics platform. After testing a prototype of the system, the project partners will validate it in the field.

A part of the Ebola+ Programme

The IMI Ebola+ programme was launched in response to the Ebola virus disease (EVD) outbreak that started in western Africa in 2014. The comprehensive programme contributes to efforts to tackle a wide range of challenges in Ebola research, including vaccines development, clinical trials, and transport, as well as diagnostics. The programme complements work being carried out with the support of other funding bodies. In addition to Ebola, the programme will also address related diseases, such as Marburg.

About Ebola and related diseases

Ebola virus disease (EVD), previously known as Ebola haemorrhagic fever, is a rare and deadly disease caused by infection with one of the Ebola virus strains. The virus spreads in the human population through direct human-to-human contact with the bodily fluids of infected patients who are showing symptoms. It has an incubation period of 2-21 days, and it usually begins with flu-like symptoms, but rapidly progresses to multiple organ failure and blood-clotting abnormalities which manifest as internal and external haemorrhages (bleeding). It is fatal in between 25% and 90% of cases. There is currently no licensed treatment against EVD, and the development of treatments and preventive measures such as vaccines is hampered by challenges including manufacturing-related hurdles, the stability of vaccines during transport and storage, vaccine deployment, and the time taken to diagnose cases of EVD.

Ebola is a member of the filovirus family of viruses, which also includes Marburg virus. Like Ebola, Marburg causes cause severe, often fatal haemorrhagic fever in humans and other primates (monkeys, gorillas and chimpanzees), and like Ebola, it is transmitted directly from one person to another. (In contrast, other viruses that cause haemorrhagic fevers are spread via intermediate hosts - for example, dengue fever is transmitted by mosquitoes.) There is no specific treatment or vaccine against Marburg haemorrhagic fever.

The 2014-15 Ebola epidemic was unprecedented in its scale and geographical distribution. By the middle of 2015, World Health Organization (WHO) statistics recorded over 27 000 cases and 11 000 deaths from the disease, most of them in Guinea, Liberia, and Sierra Leone. The epidemic highlighted the need for research into better vaccines, diagnostics and treatments to stop future epidemics in their tracks.

Achievements & News

Mofina develops device for faster testing of deadly Ebola
September 2017

Ebola is a deadly disease which spreads among humans through direct contact with bodily fluids of infected patients. There is currently no licensed treatment, and development of medications and vaccines is hampered by challenges including the time required for diagnosis. IMI's Mofina project researchers have developed a portable device to test in the field whether a person has caught the deadly Ebola disease. It gives reliable results in 75 minutes, which can help contain outbreaks and save lives. ‘The quicker contacts of Ebola sufferers are tested, the easier it is to contain the outbreak,’ explains project coordinator Edmund Newman of Public Health England, an executive agency of the UK’s Department of Health. ‘MOFINA addresses the challenge of rapid testing and containment during an outbreak by providing a mobile testing capability that can be taken to the patient and followed up with appropriate action based on the result.’ The product is now commercially available. It is anticipated that potential buyers could include public health institutes, diagnostic services, the World Health Organisation (WHO), and non-governmental organisations tackling outbreaks. In the long term, the platform could be expanded to cover more pathogens. The project’s partners aim to develop and manufacture diagnostic tools for each of the WHO’s ‘priority pathogens’ – those viruses and bacteria posing the greatest threat to human health. ‘The consortium is now looking at ways to secure funding to further develop this technology so a wider range of infectious disease can be tested for in the one sample: not just Ebola strains but other similar diseases such as Lassa fever and hantaviruses,’ says Newman.
Full story

Mofina project successfully tests new Ebola diagnostic device
Although the Ebola outbreak seems to be over, the WHO has warned that West Africa may see flare-ups of the virus. Therefore, there is still an urgent need for fast, reliable tests to determine if a patient with fever symptoms may be infected with the Ebola virus. ###IMI’s Mofina project is working on a new diagnostic test that will deliver results in about an hour, a device which will be crucial for diagnosis of the disease in sites where high-end laboratory infrastructure is not available. Recently the project reported a major milestone: the device designed to test for the Ebola virus and other related filoviruses has been successfully tested in three European reference labs and has also passed initial field studies in Sierra Leone. The device is now ready for product registration and the data obtained from lab and field tests is being submitted to the regulatory authorities. According to the project's coordinators, this important milestone wouldn’t have been possible without the public-private nature of IMI: for example, the industrial partners in the project couldn’t have done the work without the collaboration of public facilities which are able to handle the highly contagious Ebola virus. Further field tests, which will be conducted in Guinea and Ghana on patient samples in autumn, are expected to confirm initial results from Sierra Leone. After successful registration, the device will become available for diagnosis in patients e.g. during an outbreak or in monitoring and surveillance programmes. (September 2016)

Participants Show participants on map

Universities, research organisations, public bodies, non-profit groups
  • (UK) Department of Health, Leeds, United Kingdom
  • Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany
  • Foundation for Innovative New Diagnostics, Geneva, Switzerland
  • Istituto Nazionale Malattie Infettive Lazzaro Spallanzani, IRCCS, Rome, Italy
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
  • altona Diagnostics GmbH, Hamburg, Germany
Non EFPIA companies
  • Alere Technologies GmbH, Jena, Germany

CONTACT

Project coordinator
Edmund Newman
Department of Health (Public Health England)
Edmund.Newman[at]phe.gov.uk