News & Views
Agreement Speeds Access to SARS-Cov-2 Antigen Test
Feb 18 2021
A partnership which will accelerate Avacta’s AffiDX™ SARS-CoV-2 lateral flow rapid antigen test to market is enabling the test to be CE marked for professional use under Mologic’s existing ISO13485 quality system. The CE mark will then be transferred to Avacta when it receives ISO13485 accreditation, which is expected by the end of March 2021. AffiDX supports COVID-19 testing in low and middle income countries
The partnership immediately provided Avacta with additional manufacturing capacity through Mologic and its partners including Global Access Diagnostics (GAD), in addition to the scaled-up manufacturing capacity being built with BBI and Abingdon Health. Combined, these partnerships will deliver several millions of tests per month; Avacta is also continuing discussions with other manufacturers in the UK and overseas to access additional capacity to meet demand.
Clinical evaluation of the lateral flow test is currently being carried out at a hospital in mainland Europe and Avacta will shortly initiate further clinical validation studies in the UK and abroad.
Dr Alastair Smith, Chief Executive Officer of Avacta Group said: “I am very pleased to announce this partnership with Mologic, which follows a close collaboration over recent months. I am also delighted that this collaboration provides an opportunity for Avacta to support antigen testing in low and middle income countries through Mologic’s international manufacturing links.
“The longer-term collaboration with Mologic, on a range of diagnostic tests, offers a significant potential opportunity for the Group. The combination our technologies to generate a world-leading second-generation antigen test for SARS-CoV-2 is an exciting possibility.”
Mark Davis, Chief Executive Officer of Mologic, said: “Mologic offers a highly versatile range of scientific and manufacturing services for the development of diagnostic technology. We are very pleased to be working with Avacta to apply our expertise in this important project and look forward to it paving the way for further collaborations.”
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