Owen Mumford Ltd. of Woodstock, Oxfordshire at MEDICA 2018 in Düsseldorf -- MEDICA - World Forum for Medicine
Manufacturers

Owen Mumford Ltd.

Brook Hill, OX20 1TU Woodstock, Oxfordshire
United Kingdom of Great Britain and Northern Ireland

This company is co-exhibitor of
Gambica Association Limited

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MEDICA 2018 hall map (Hall 3A): stand 3AD02-2

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MEDICA 2018 fairground map: Hall 3A

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  • 03  Diagnostics
  • 03.02  Immunochemistry testing, immunology testing
  • 03.02.02  Diagnostic rapid tests

Diagnostic rapid tests

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Nov 12, 2018

Late HIV diagnosis: Tackling a persistent problem

During the first few years of the HIV epidemic, a person who developed AIDS could expect to live for less than a year. (1)  In San Francisco between 1981 and 1985 – the year the first blood test for HIV was developed (2) - median survival after AIDS was diagnosed was just 10.1-12.6 months.1 Today, the life expectancy for a person who is diagnosed and starts antiretroviral treatment (ART) rapidly after HIV infection probably approaches that of the general population. (3) 

The World Health Organisation (WHO) set a global target that 90% of all people living with HIV know their status, 90% of those diagnosed as HIV positive start ART, and 90% of all people receiving ART show durable viral suppression. (4)  In 2017, these proportions were 75%, 79% and 81% respectively. (5)  Moving closer to the WHO targets depends on focusing on groups and areas with a high prevalence and improving access to high-quality tests to diagnose and monitor HIV. (4) Currently, however, many people with HIV are diagnosed late despite the widespread availability of accurate tests. (6, 7, 8, 9). 

Broadly, late diagnosis means that a person is diagnosed when their CD4+ T-cell count is below 350 cells/mm (3). A person who is diagnosed when their CD4+ T-cell count is below 200 cells/mm3 has ‘advanced HIV disease’ (AHD). Patients at these counts may be asymptomatic or present with an AIDS-defining event (illness), such as Kaposi’s sarcoma, Pneumocystis jiroveci pneumonia or cytomegalovirus retinitis. 

People who start ART when their CD4+ count is below 350 cells/mm (3)  show a worse prognosis and have greater healthcare costs than those with higher counts. (8) During the Insight Start study, for example, 4685 HIV-positive adults with CD4+ counts of more than 500 cells/mm3 started ART immediately or waited until their count fell to 350 cells/mm (3) or they developed AIDS or another condition needing ART. The primary end point was any serious AIDS-related event, serious non–AIDS-related event, or death from any cause. (10) 

During the average follow up of 3.0 years, the primary end point was 57% less common in those who started ART immediately. Serious AIDS-related events and serious non–AIDS-related events were 72% and 39% less likely respectively in those who started ART immediately. (10) 

A study from England and Wales reported that people who were diagnosed late were 3.5 times more likely to die, usually from AIDS-related events. Mortality was 10 times higher during the year after a late diagnosis compared to those who were diagnosed rapidly.3 People diagnosed late are also typically unaware that they are HIV positive for approximately three to five years (6 ) and, as a result, are more likely to transmit HIV than those diagnosed promptly. (8) 

Despite the well-established benefits of early ART, the proportion of people diagnosed late in the UK remained approximately 40% between 2012 and 2017, when 43% of diagnoses were late. Moreover, 5% had a AIDS-defining disease at diagnosis.(6 )
A Israeli study reported that of 356 patients with HIV, 33% were diagnosed late and 16% had AHD.7 In 20,965 patients from Holland, 53% were diagnosed late and 35% had AHD. However, the proportion of people with late presentation decreased from 62% in 1996 to 42% in 2013. The proportion with AHD decreased from 46% to 26% during this time. (8) 

Overall, the European Centre for Disease Prevention and Control estimates that, depending on the country, up to 43% of people living with HIV in Europe remain undiagnosed. On average, 47% of HIV cases are diagnosed late and 28% of people have AHD. The proportion of people with HIV diagnosed late exceeds 50% in nine European countries, including Italy, Greece and Sweden. (9) 

The introduction of the Simplitude™ Pro HIV (1&2) rapid diagnosis test at MEDICA, 2018 in Düsseldorf addresses this important issue, meeting the need for a reliable point-of-care diagnostic test (the overall sensitivity and specificity is 99.6%) that is simple to use and offers patients and healthcare workers the confidence to start ART and take steps to prevent transmission.  

“Earlier diagnosis enables people with HIV to start ART sooner, which increases their chances of living a long and healthy life and reduces the risk of transmission,” says Tania MacKenzie, Senior Product Manager for Diagnostics at Owen Mumford Ltd. “We believe that the convenience and prompt results offered by point-of-care tests, such as Simplitude™ Pro HIV (1&2),  in community-based settings worldwide will help reduce the number of patients diagnosed late and so further improve outcomes for people living with HIV.”  

·       To learn more about Simplitude™ Pro HIV (1&2) visit our stand or visit owenmumford.com 

References

1.  Lemp GF, Payne SF, Neal D et al Survival trends for patients with AIDS JAMA 1990;263:402-406

2.  Greene WC A history of AIDS: Looking back to see ahead European Journal of Immunology 2007;37:S94-S102

3. Croxford S, Kitching A, Desai S et al Mortality and causes of death in people diagnosed with HIV in the era of highly active antiretroviral therapy compared with the general population: An analysis of a national observational cohort The Lancet Public Health 2017;2:e35-e46

4. Habiyambere V, Dongmo Nguimfack B, Vojnov L et al Forecasting the global demand for HIV monitoring and diagnostic tests: A 2016-2021 analysis PLOS ONE 2018;13:e0201341

5. UNAIDS 2017 global HIV statistics Available at www.unaids.org/sites/default/files/media_asset/UNAIDS_FactSheet_en.pdf

6. Public Health England Trends in new HIV diagnoses and people receiving HIV-related care in the United Kingdom: data to the end of December 2017 Available at assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/738222/hpr3218_hiv17_v2.pdf

7. Levy I, Maor Y, Mahroum N et al Missed opportunities for earlier diagnosis of HIV in patients who presented with advanced HIV disease: A retrospective cohort study BMJ Open 2016;6:e012721. DOI:10.1136/bmjopen-2016-012721

8. Op de Coul ELM, van Sighem A, Brinkman K et al Factors associated with presenting late or with advanced HIV disease in the Netherlands, 1996–2014: results from a national observational cohort BMJ Open 2016;6:e009688. 10.1136/bmjopen-2015-009688

9. European Centre for Disease Prevention and Control HIV testing Monitoring implementation of the Dublin Declaration on Partnership to Fight HIV/AIDS in Europe and Central Asia: 2017 progress report Available at ecdc.europa.eu/sites/portal/files/documents/HIV%20testing.pdf

10.  The INSIGHT START Study Group Initiation of Antiretroviral Therapy in Early Asymptomatic HIV Infection New England Journal of Medicine 2015;373:795-807

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Nov 12, 2018

Owen Mumford and Atomo Diagnostics: Partners in point-of-care innovation

Early diagnosis enables people with HIV to start antiretroviral drug treatments as soon as possible in the course of their disease. This, in turn, increases their chance of living a long and healthy life and reduces the risk of transmission. The Simplitude™ Pro HIV (1&2) rapid diagnostic test, which Owen Mumford is launching to distributors at MEDICA 2018 in Düsseldorf, Germany, meets the need for an effective point-of-care diagnostic test that is safe, reliable, and simple to use. A unique all-in-one HIV rapid test device, Simplitude™ Pro HIV (1&2) gives an accurate result in just 15 minutes from a tiny drop of capillary blood obtained from a fingertip.

Simplitude™ Pro HIV (1&2) was developed for Owen Mumford by Atomo Diagnostics, a product design and manufacturing company, based in Sydney, Australia, that specialises in the development of integrated diagnostic test devices.

Since forming their strategic partnership in June 2018, the companies have forged a close and collaborative working relationship. So, what are the factors that make this relationship work? 

A “perfect” partnership
A long-established and respected company, with more than 60 years’ experience as a leading player in the medical device industry, Owen Mumford is commercialising Simplitude™ Pro HIV (1&2) throughout Europe.  

“The partnership with Owen Mumford is a perfect strategic fit,” explains John Kelly, Atomo’s founder and chief executive officer, “with our companies having complementary skills and capabilities. Owen Mumford has a track record of successful commercialisation,” says Mr Kelly, “and it knows how best to take a product to market.”

Based in Oxfordshire, UK, Owen Mumford has sales offices in the USA, Mexico, France, and Germany, with manufacturing facilities in the UK and Malaysia, and specialist distributors across five continents. “We have been impressed by the capabilities of Owen Mumford’s sales and distribution operations,” says Mr Kelly, “and also by the extent of its established international network of trusted distributors.” 

Although Atomo has a sales office in the UK, most of the company’s senior personnel are based in Australia; nonetheless, despite the geographical distance and associated time difference, Atomo and Owen Mumford have very quickly formed a productive and collaborative partnership. Mr Kelly explains, “The key to the relationship is regular, open, and effective communication.” 

Heritage and innovation
Owen Mumford works with 7 of the 10 most successful pharmaceutical and diagnostic companies, many smaller organisations and numerous distributors. Over the years, it has built a reputation for developing and delivering full-service solutions in partnership with manufacturers and distributors.  

“Owen Mumford provides a custom-made service for device development from concept through to manufacturing including design, QA compliance, commercialisation and full regulatory approval,” says Tania MacKenzie, Senior Product Manager for Diagnostics at Owen Mumford. “For distributors looking to market high quality, proven devices, we offer a range of branded products that improve healthcare outcomes and reduce costs, supported by added-value initiatives such as provision of education materials and training.”

Owen Mumford is, Ms MacKenzie says, fully committed to innovation. For example, Owen Mumford developed the world’s first re-usable automatic insulin delivery pen and blood sampling device. Owen Mumford is also actively involved in improving the management of some of the world’s leading causes of death and disability, including allergies, autoimmune diseases, cancers, cardiovascular disease, diabetes and neurological conditions.  

Since being founded in 1952, Owen Mumford built its success on high quality, advanced engineering that improves the patient experience and reduces analytical errors, recruiting top talent and managing risk. “We work with leading medical device and pharmaceutical partners, distributors and healthcare professionals across the globe to improve patient experience,” Ms MacKenzie adds. “Owen Mumford knows what is important to a potential partner. We can deliver a full support system to meet each partner’s needs, such as providing help in bringing products to market, offering training and regulatory support and helping to raise awareness of conditions such as HIV and diabetes.”  

“Atomo and Owen Mumford are a good fit, having the same drive and ambition,” observes Mr Kelly. The companies share a strong desire to extend their partnership and Mr Kelly explains that they “hope that the development and commercialisation of Simplitude™ Pro HIV (1&2) will be but the first step.” The parties are currently exploring further opportunities for strategic collaboration. 

“With a world population of more than 7 billion, the market for innovative medical devices is growing exponentially, opening new opportunities to bring life-changing products to more people,” Ms MacKenzie concludes. “Our priorities within our partnerships are to deliver innovative solutions, on time and on budget and always using high-quality engineering. We have a wide range of existing products and the potential to launch new devices to meet future needs, and we would be delighted to discuss further opportunities with distributors and manufacturers.” 

·       To learn more about Simplitude™ Pro HIV (1&2) and to discuss partnership and distribution opportunities, please visit us in hall 3A/stand 3AD02-2 MEDICA 2018 or visit owenmumford.com

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Nov 12, 2018

Simplitude™ Pro HIV launch drives early diagnosis of HIV in European market

Owen Mumford, the UK company that has been at the forefront of medical device innovation for over 65 years, is launching the rapid diagnostic HIV test, Simplitude™ Pro HIV (1&2) to European distributors at MEDICA 2018 in Dusseldorf today. 

Owen Mumford’s Senior Product Manager for Diagnostics, Tania MacKenzie says, “Simplitude™ Pro HIV (1&2) is the first rapid diagnostic test with built-in safety lancet, blood collection unit and strip test.  

“The introduction of the Simplitude™ Pro HIV (1&2) rapid diagnosis test at MEDICA, 2018 addresses an important issue, meeting the need for a reliable point-of-care diagnostic test (the overall sensitivity and specificity is 99.6%) that is simple to use, and provides convenient and prompt results to support early diagnosis of HIV.

“Earlier diagnosis enables people with HIV to commence antiretroviral (ART) drug treatment more quickly which improves outcomes, increasing the patient’s chance of living a long and healthy life and reducing the risk of transmission” 

Overall, the European Centre for Disease Prevention and Control estimates that, depending on the country, up to 43% of people living with HIV in Europe remain undiagnosed. On average, 47% of HIV cases are diagnosed late and 28% of people have advanced HIV disease (AHD) where patients can be asymptomatic, or present with an AIDS-defining condition, such as pneumonia. The proportion of people with HIV diagnosed late exceeds 50% in nine European countries, including Italy, Greece and Sweden.[1]  

The Simplitude™ Pro HIV (1&2) is the result of a strategic partnership between Owen Mumford, a leading player in the medical device industry and Atomo Diagnostics, a product design and manufacturing company, based in Australia that specialises in the development of integrated diagnostic test devices.   

The integrated device with built-in lancet and blood collection unit enables the healthcare professional to collect and transfer the correct amount of blood and conduct the steps necessary to perform the test accurately.  This addresses several of the key challenges identified with rapid diagnostic tests (RDTs) such as under collection of blood and complicated instructions which research[2] has been shown to lead to user error. 

Owen Mumford will be demonstrating the Simplitude™ Pro HIV (1&2) throughout MEDICA in Hall 3A – stand 3AD02-2. 

ABOUT OWEN MUMFORD

Owen Mumford is a major healthcare company and device manufacturer that commercialises pioneering medical products in its own brand and custom device solutions for the world’s major pharmaceutical and diagnostic companies.  Owen Mumford’s goal is to enhance access to diagnostics, encourage adherence to treatment and reduce healthcare costs, making a world of difference to a world of people.

For more information, please contact :  Gillian Gibbons, JJ Marketing 07795 342804 or by email om@jjmarketing.co.uk

[1]  European Centre for Disease Prevention and Control HIV testing Monitoring implementation of the Dublin Declaration on Partnership to Fight HIV/AIDS in Europe and Central Asia: 2017 progress report Available at ecdc.europa.eu/sites/portal/files/documents/HIV%20testing.pdf

[2] Figueroa et al (2018) Reliability of HIV rapid diagnostic tests for self-testing compared with testing by health-care workers: a systematic review and meta-analysis. The lancet HIV. ISSN 2405-4704 DOI: https://doi.org/10.1016/S2352- 3018(18)30044-4

 
 





 

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