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From the category archives: Omega News

News

18 March 2019 CE-Mark for VISITECT® CD4 Advanced Disease test

Omega (AIM: ODX), the medical diagnostics company focused on allergy, food intolerance and infectious disease, announces that it has CE-Marked its VISITECT® CD4 Advanced Disease test for monitoring people living with HIV. The VISITECT® CD4 Advanced Disease test utilises a cut-off of 200 CD4 cells/mm³ of blood, a level at which patients’ immune systems are so weakened by HIV that they are at risk of infection by other life-threatening diseases. The technical file supporting the CE-Mark will form the basis of the additional regulatory approvals that the Company will seek through the UNITAID-funded Expert Review Panel for Diagnostics (“ERPD”), hosted by the Global Fund to Fight AIDS, Tuberculosis and Malaria. The ERPD outcome is a time-limited, risk-based recommendation on eligibility for procurement whilst the Company undergoes the World Health Organisation Prequalification programme. This programme aims to ensure that clinical diagnostics, medicines and vaccines meet global ...

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06 March 2019 VISITECT CD4 Update

Omega (AIM: ODX), the medical diagnostics company focused on allergy, food intolerance and infectious disease, announces that it has received its first purchase orders for its VISITECT® CD4 350 cut-off test and continues to make progress with its VISITECT® CD4 Advanced Disease test. VISITECT® CD4 350 cut-off test The Company is pleased to report that it has received its first purchase orders for its CE-Marked VISITECT® CD4 350 cut-off test from distributors supplying into Indonesia, Moldova and Papua New Guinea. As expected by the Company, the order quantities are low at this stage and reflect distributors’ intentions to seed their private business-to-business market channels in the initial stages. Nevertheless, this is an endorsement of the Company’s ability to develop and then commercialise this product through the regulatory processes in international markets. We expect to supply customers before the end of the current financial year. As previously indicated, we see Niger ...

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01 March 2019 Board Appointment

OMEGA DIAGNOSTICS GROUP PLC (“Omega” or the “Company” or the “Group”) Omega (AIM: ODX), the medical diagnostics company focused on allergy, food intolerance and infectious disease, announces the appointment of Jeremy Millard as Non-Executive Director to the Board with immediate effect, after a thorough search process. The Board consider Jeremy to be independent and it is anticipated that he will, in due course, be appointed to the Audit and Remuneration Committees of the Company. Jeremy has 20 years investment banking experience and was previously a partner at Smith Square Partners LLP where he provided strategic and corporate advice to clients in the science, technology and telecommunications sectors, prior to which he headed up the technology practice at Rothschild in London. Jeremy is currently a Non-Executive Director and chairman of the audit committee of AIM-listed Idox plc and a Non-Executive Director of AIM-listed Ilika Plc. Bill Rhodes, Interim Non ...

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20 April 2018 Allersys Distribution Agreement

Omega announces that it has signed a global distribuon agreement with Immunodiagnostic Systems Limited for its Allersys® range of allergy assays.

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Omega Diagnostics and Burnet Institute announce VISITECT® CD4 CE-Marking

Omega Diagnostics, the medical diagnostics company focused on allergy, food intolerance and infectious disease, is delighted to announce it has successfully achieved CE-Marking of its VISITECT® CD4 test for supporting the management of people living with HIV, following successful performance evaluations in India and the UK. VISITECT® CD4, co-developed with the Burnet Institute, is the world’s first instrument-free and affordable rapid test for determining CD4 threshold in people living with HIV. It is designed for use at the point-of-care and provides a means for decentralisation of CD4 testing capacity to where it is most needed. VISITECT® CD4 will enable those patients in rural locations to access testing more easily and does not require investment in equipment or highly technical scientific staff to operate. The test will now go forward into further regulatory processes that are necessary before being implemented in those regions where HIV remains a significant public health chall ...

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Grant of US patent for Visitect CD4

Omega has been informed by the Burnet Institute that its exclusively licensed CD4 test for monitoring HIVpositive patients has been awarded a US Patent.

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