Charles Sternberg, Assistant Editor02.08.21
Avacta Group plc, the developer of Affimer biotherapeutics and reagents, and Mologic Ltd have entered into a commercial partnership to accelerate to market Avacta’s AffiDX SARS-CoV-2 lateral flow rapid antigen test. Avacta will also support antigen testing in low and middle income countries1 by providing access to Avacta’s spike antigen test through Mologic.
The partnership will provide a faster route to market for Avacta’s rapid antigen test by CE marking it 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.
The partnership also provides 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 manufacturing partnerships will deliver several millions of tests per month, and potentially much higher with further investment. Avacta is also continuing its discussions with other manufacturers in the UK and overseas in order 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.
The partnership between Avacta and Mologic also provides a framework agreement for the future development of a pipeline of tests in a range of disease areas. The possibility of combining Avacta’s spike antigen test with Mologic’s nucleocapsid antigen-based technology1,2 in a single lateral flow device is already being explored. A hybrid antigen test such as this is expected to be a world first and has the potential to deliver an extremely sensitive lateral flow coronavirus antigen test.
Avacta will provide the market with a detailed business update later this month once definitive clinical data from the lateral flow test evaluation is available.
Comments from the CEOs
Dr. Alastair Smith, chief executive officer of Avacta Group, commented, “I am very pleased to announce this partnership with Mologic, which follows a close collaboration over recent months. The partnership provides Avacta with a low-risk route to CE marking our rapid antigen test during Q1 ahead of achieving our own ISO13485 accreditation.
“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.
“The critical next step is to demonstrate that the outstanding laboratory performance of our rapid spike antigen test is reflected in its clinical performance. Customs issues following the UK's departure from the EU caused delays to the tests being delivered to our clinical partner in Europe, but the clinical evaluation is now progressing. We have also identified UK clinical groups outside of the FALCON/CONDOR programmes whose data can be used for CE marking. Therefore, if the clinical evaluation in Europe is positive, we are ready to move quickly into full clinical validation in Europe and the UK, and subsequent CE marking through Mologic. With this approach it is possible to bring the test to market around the end of the first quarter of this year.
“I look forward to further updating the market on the lateral flow test once we have definitive clinical performance data.”
Mark Davis, chief executive officer of Mologic, said, “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.”
References:
1 https://wellcome.org/grant-funding/guidance/low-and-middle-income-countries
2 https://mologic.co.uk/mologic-receives-ce-mark-approval-for-professional-use-covid-19-rapid-antigen-test/
The partnership will provide a faster route to market for Avacta’s rapid antigen test by CE marking it 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.
The partnership also provides 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 manufacturing partnerships will deliver several millions of tests per month, and potentially much higher with further investment. Avacta is also continuing its discussions with other manufacturers in the UK and overseas in order 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.
The partnership between Avacta and Mologic also provides a framework agreement for the future development of a pipeline of tests in a range of disease areas. The possibility of combining Avacta’s spike antigen test with Mologic’s nucleocapsid antigen-based technology1,2 in a single lateral flow device is already being explored. A hybrid antigen test such as this is expected to be a world first and has the potential to deliver an extremely sensitive lateral flow coronavirus antigen test.
Avacta will provide the market with a detailed business update later this month once definitive clinical data from the lateral flow test evaluation is available.
Comments from the CEOs
Dr. Alastair Smith, chief executive officer of Avacta Group, commented, “I am very pleased to announce this partnership with Mologic, which follows a close collaboration over recent months. The partnership provides Avacta with a low-risk route to CE marking our rapid antigen test during Q1 ahead of achieving our own ISO13485 accreditation.
“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.
“The critical next step is to demonstrate that the outstanding laboratory performance of our rapid spike antigen test is reflected in its clinical performance. Customs issues following the UK's departure from the EU caused delays to the tests being delivered to our clinical partner in Europe, but the clinical evaluation is now progressing. We have also identified UK clinical groups outside of the FALCON/CONDOR programmes whose data can be used for CE marking. Therefore, if the clinical evaluation in Europe is positive, we are ready to move quickly into full clinical validation in Europe and the UK, and subsequent CE marking through Mologic. With this approach it is possible to bring the test to market around the end of the first quarter of this year.
“I look forward to further updating the market on the lateral flow test once we have definitive clinical performance data.”
Mark Davis, chief executive officer of Mologic, said, “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.”
References:
1 https://wellcome.org/grant-funding/guidance/low-and-middle-income-countries
2 https://mologic.co.uk/mologic-receives-ce-mark-approval-for-professional-use-covid-19-rapid-antigen-test/
