ODX.L Regulatory News (ODX)

AIM: ODX 

Omega Diagnostics Group PLC

("Omega" or the "Company")

Collaboration with the Burnet Institute, Melbourne

Omega, the medical diagnostics company focussed on allergy, food intolerance and infectious disease, announces that, subsequent to entering into agreements providing worldwide exclusive access to two point-of-care ('POC') tests for CD4 and Syphilis developed by the Burnet Institute in Melbourne, Australia, the Company has produced the first batch of prototype CD4 tests that have passed preliminary evaluation at the Burnet Institute.

CD4

Testing for the number of CD4 T-cells is a vital component for the management and care of people suffering from HIV and is required to determine when HIV patients should commence antiretroviral treatment ('ART'). In addition, the World Health Organisation ('WHO') recommends patients are tested at least every 6 months thereafter to monitor their health during ART. HIV is a major global health challenge affecting approximately 33 million people worldwide, of whom more than 25 million are in developing countries and it is the primary cause of global disease burden in 12 countries, including South Africa and India.

The current market for monitoring of CD4 T-cells is dominated by flow cytometry, a technique which requires expensive laboratory-based equipment, well trained laboratory technicians and cold chain storage for reagents, all requiring the test to be carried out in centralised locations. Given this diagnostic landscape, CD4 testing remains a bottleneck to commencing ART where HIV patients living in rural areas often have difficulty in accessing a clinic and where the time between testing and reporting results can often lead to a significant patient loss to treatment. There is a clear unmet need for a lower cost POC test that can be conducted in doctors' surgeries and outreach clinics in resource-poor settings.

The Burnet Institute has developed a POC CD4 test that meets this unmet need and, further to the exclusive licensing agreement entered into with the Company, Omega has manufactured a first small-scale batch of prototype devices. The Company intends to complete the technology transfer in advance of the commercial launch of the POC CD4 test at the 19th International AIDS Conference in Washington DC on 22-27 July 2012.

There is still further work to do in terms of manufacturing scale-up and field trial evaluations before the first commercial sale of product can take place and therefore, it is not expected that there will be any revenue impact in the current financial year to 31 March 2013. However, the progress to date is very encouraging in achieving the outlined strategy of transforming the performance of the Group and the infectious disease segment.

Syphilis IgM

Subsequent to entering into the licensing agreement for CD4, the Company and the Burnet Institute have also signed an exclusive agreement providing Omega with access to a POC test for active syphilis infections.

In many developing countries, congenital syphilis is a leading cause of still births and deaths among neonates and the Burnet Institute has developed a POC test which can specifically detect IgM class antibodies. The test has the advantage of differentiating between active infections and those that have been treated in the past.

The technology transfer for this test has yet to commence, however, it is anticipated it will be a simpler manufacturing process than for CD4.

Andrew Shepherd, Founder and Chief Executive of Omega Diagnostics added: "This is an important development for our infectious diseases business and we are delighted the Burnet Institute has chosen Omega to develop these important tests. The CD4 test overcomes many of the limitations commonly associated with the traditional technique of flow cytometry, offering a cost-effective means of obtaining immediate results. Establishing when a patient should commence therapy will improve health and help to reduce transmission of the virus."

Associate Professor David Anderson, Deputy Director of the Burnet Institute and leader of the team that developed the test, added: "According to UNAIDS, there are 15 million people who should be getting access to antiretroviral therapy but aren't, just because they can't get access to an affordable CD4 test in their communities. This test will provide access for even the most remote and disadvantaged patients."

Contacts:

Information about the Burnet Institute:

The Burnet Institute is an Australian, not-for-profit, unaligned and independent organisation that links medical research with public health action, recognising that solutions to many of the major global health problems require comprehensive and innovative responses. These include novel discoveries, such as the development of new vaccines and diagnostic tests, and the better use of existing best-practice health interventions.

With an estimated 33 million people living with HIV and millions more affected by other infectious diseases, the Burnet Institute is playing its part in trying to improve the health of disadvantaged, poor or otherwise vulnerable communities.

The CD4 test has been developed to date with funding from The National Health and Medical Research Council, the Doris Duke Charitable Foundation, the CD4 Initiative (funded by the Bill and Melinda Gates Foundation), the Burnet Institute and the Medical Research Commercialisation Fund.