Omega Diagnostics Group PLC – Development Update – Visitect® CD4 and Allergy
Omega (AIM: ODX), the medical diagnostics company focused on allergy, food intolerance and infectious disease, announces the following development update on its infectious disease and allergy projects.
Infectious Disease – Visitect® CD4 update
Since the trading update on 15 April 2015, the Company has continued to test devices on a large number of patient samples with the aim of optimising performance and deciding on suitable in-house manufacturing processes. The Company confirms that it has now made three pilot batches of devices, all of which have yielded comparable results and which demonstrate that Visitect® CD4 is capable of meeting the Company’s performance design goals in comparison to flow cytometry when tested on HIV positive patients. The Company confirms that its internal investigation phase is now complete as planned.
The outcome of this investigation phase has been the selection of in-house manufacturing processes which are scalable and which will now be subject to verification and validation leading to the release of Visitect® CD4 test devices for re-evaluation in the field.
We remain very confident of the prospective commercial success of Visitect® CD4 and will provide further updates in due course.
Allergy Development – Allersys® automation update
Our allergy development programme has continued to make progress. We now have 32 allergens that have been optimised to show equivalent performance to the market leading product. Of these, 22 have completed their claim support work. The manufacturing process and recent amendments to the instrument software have been validated for full scale manufacture and we now have commercial quantities for 27 allergens and associated reagents within our inventory which have all passed internal quality control procedures. These allergens will be used in beta evaluations at sites in Spain and Italy, planned in June and July respectively.
A preliminary field study comparing the Allersys® system to ThermoFisher ImmunoCAP® using eight allergens was conducted at Udine University Hospital Laboratory, Italy last year. The investigators concluded that the two systems were comparable. The results of the study have recently been accepted for an oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Annual meeting in Barcelona, 6-10 June 2015.