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.
One of the biggest challenges in containing an Ebola outbreak is quick and efficient diagnosis. Until now, patients who were suspected of having the virus had to be taken to treatment centres far away from their communities and kept in isolation centres until tests confirmed that they were not infected. Even if they were found to be healthy and subsequently released, they were often stigmatised in their local communities, as others feared that they may have been exposed to the virus. This caused psychological stress and trauma, spreading fear in local communities, and making it harder to contain outbreaks. Some people who developed symptoms would even avoid or hide from the Ebola tracing teams as they feared being ostracised.
IMI’s Mofina project developed a portable device, no bigger than a shoe box, which can be used for diagnosing all known Ebola virus strains as well as Marburg virus in the field. The testing is easy, safe, reliable, and can be performed by people with little training such as local health care workers, saving money and resources. All that is needed to perform the test is a simple prick of a finger.
The product has been validated, CE-IVD marked and is already commercially available. This is the first commercially available test that is both portable and can test for all the known Ebola virus strains. It is anticipated that potential buyers could include public health institutes, diagnostic services, WHO and non-governmental organisations tackling outbreaks.
Cooperation with key partners
According to the project partners, the success of this project would not have been possible without the collaboration between the public and private partners, brought together by IMI.
For example, the small and medium-sized enterprise (SME) within the project, Altona Diagnostics, contributed by bringing in their diagnostic test for all the different strains of Ebola that was validated and could be used in a normal lab setting. Another private partner, Alere Technologies, brought in a molecular diagnosis platform which is already used across Africa for HIV testing in the field. It is by combining those two technologies that the project partners were able to develop a unique new test which is both portable and can test for of the known Ebola virus strains.
Furthermore, thanks to the collaboration with the national public health institutes and other public partners, the project was able to validate the device on patient samples collected during the west African Ebola outbreak, and get it quickly approved for placement on the market.
Benefits for industry, SMEs, and patients
The industry benefitted from the collaboration with SMEs and the public partners in the consortium, such as leading European public health institutions.
The SME in the project benefitted from getting a detailed insight into workflows in mobile laboratories during outbreaks which will help them in developing future products. They also benefitted from fostering existing scientific collaborations, and establishing new ones.
However, it will be the patients who will benefit the most. The device produced by Mofina will help contain Ebola outbreaks in the future, by identifying infected patients much sooner than before.
What comes next?
The project partners would like to develop the device further, making it possible to test for a range of other infectious diseases, which are on the list of WHO priority pathogens, such as the Zika virus, dengue and Lassa fever.
Achievements & News
IMI’s Mofina project developed a portable device which can test for deadly Ebola in 75 minutes or less, eliminating the need to take suspected Ebola patients to treatment centres far away of their communities. In an interview with the IMI Programme office, the project’s coordinator, Edmund Newman of Public Health England, explains how Mofina’s success will save lives, and help contain future outbreaks. ###‘We now have a portable platform for testing all of the different types of Ebola virus that can run on a battery pack for up to 8 hours,' said Newman. 'It is a mobile platform that will give you a test result for all different types of Ebola within just over an hour, 75 minutes. It doesn’t require a big lab set up in the middle of the field somewhere. It is literally a finger prick of blood into an automated machine that is not much bigger than a shoe box and so it can easily be carried around and taken to the patient for testing. The device has been fully validated and verified for all the strains of Ebola that it tests for. It is commercially available and ready for the next outbreak.'
Read the full interview
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.
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 programs.
ParticipantsShow participants on map
Universities, research organisations, public bodies, non-profit groups
- Bernhard-Nocht-Institut Fuer Tropenmedizin, Hamburg, Germany
- Department of Health, Leeds, United Kingdom
- Foundation For Innovative New Diagnostics, Geneva, Switzerland
- Istituto Nazionale Per Le Malattie Infettive Lazzaro Spallanzani-Istituto Di Ricovero E Cura A Carattere Scientifico, 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
|Name||IHI funding in €|
|Altona Diagnostics GMBH||394 178|
|Bernhard-Nocht-Institut Fuer Tropenmedizin||217 992|
|Department of Health||332 460|
|Istituto Nazionale Per Le Malattie Infettive Lazzaro Spallanzani-Istituto Di Ricovero E Cura A Carattere Scientifico||217 992|
|Total Cost||1 162 622|