Business
VISITECT® CD4 update
VISITECT® CD4 update.
About this update from Cambridge Nutritional Sciences Plc
[{"type":"text","content":"\n \nRNS Number : 9417R Omega Diagnostics Group PLC 06 March 2019 \n\n \nOMEGA DIAGNOSTICS GROUP PLC \n(\"Omega\" or the \"Company\" or the \"Group\")\n \nVISITECT® CD4 update\n \nOmega (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. \n \nVISITECT® CD4 350 cut-off test\n \nThe 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.\n \nAs previously indicated, we see Nigeria as being the single largest market for this version of the test and, whilst we are still awaiting our first order from Nigeria pending a performance evaluation, we remain confident of the potential to deliver shareholder value from this opportunity. We have received ethics approval from the National Health Research Ethics Committee of Nigeria and will provide a further update on progress of the evaluation in due course.\n \nVISITECT® CD4 Advanced Disease test\n \nOur VISITECT® CD4 Advanced Disease test utilises a lower 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.\n \nWe have now achieved two further key milestones for this project:\n \n· The successful completion of all internal verification studies by our development team. \n· The successful completion of an external performance evaluation of venous whole blood samples.\nThese studies have completed in line with management's expected timelines and, to CE-Mark our Advanc...