ProAxsis Limited (www.proaxsis.com), the Belfast-based respiratory diagnostics company, has successfully completed the Performance Evaluation study of the COVID-19 antibody test, initially created by AstraZeneca, with impressive results.
The assay has exceptional levels of sensitivity and specificity of 100% and 99.3% respectively, and enables the SARS-CoV-2 antibodies to be measured and tracked over time in individuals. This assay requires a simple blood sample and will be launched into the research and clinical trials markets, further strengthening ProAxsis’s expanding product range and international customer offering.
ProAxsis previously announced that it had entered into an exclusive licensing agreement with the global biopharmaceutical company AstraZeneca for the Worldwide commercialisation rights of a SARS-CoV-2 (the virus associated with COVID-19) serology Enzyme-Linked ImmunoSorbent Assay (ELISA) that detects antibodies to SARS-CoV-2. The highly skilled ProAxsis team have further developed and validated this valuable assay, which in addition has been rigorously tested by Professor Tara Moore, a leading expert in this field.
Hence, ProAxsis is now delighted to confirm that the necessary work for CE Marking has been completed and as such, a notification has been sent to the MHRA. The company expects acknowledgment of receipt from the MHRA shortly, which is a prerequisite of market launch.
In return for providing access to the required intellectual property and technical know-how, AstraZeneca will receive an undisclosed royalty fee on future Global net sales of the assay.
Speaking about the news, Professor Tara Moore, Professor of Precision Medicine at Ulster University, commented:
“This assay performed exceptionally well in the Performance Evaluation study which analysed >1100 clinical serology samples demonstrating levels of sensitivity and specificity of 100% and 99.3% respectively, which was extremely impressive. The assay was able to detect IgG antibodies in blood samples from previously infected individuals, vaccinated individuals and also detected IgG from individuals known to be infected by the different SARS-CoV-2 variants – Alpha, Delta and Omicron. Furthermore, strong evidence of assay specificity for SARS-CoV-2 antibodies was found when the assay was assessed against over 100 serology from virus infections including common corona virus, influenza virus and many other common respiratory viruses. The full data set will be published in a peer reviewed journal at the earliest opportunity.”
Ruth March, SVP, Precision Medicine, AstraZeneca, added:
“The development of this serology ELISA by our team is another example of AstraZeneca’s comprehensive response to the COVID-19 pandemic. We are delighted to see the formal validation of the assay and the results of the independent Performance Evaluation study that has formed a critical part of the submission for registration of the assay with a CE Mark.”
Dr David Ribeiro, CEO of ProAxsis, said:
“This is clearly great news for both ProAxsis and AstraZeneca. The initial work conducted by AstraZeneca provided a strong framework for our team to further develop, optimise and validate the antibody assay. A critical component of the validation process was the completion of an external independent Performance Evaluation study, and we greatly appreciate the efforts of Professor Tara Moore to complete this work in a timely and highly professional manner.”
Any enquiries concerning the new SARS-CoV-2 serology assay can be directed to firstname.lastname@example.org.
ProAxsis Limited is a commercial diagnostics company, based in Northern Ireland, and with a rapidly growing global client list of pharmaceutical companies and academic laboratories. The company has already CE Marked their activity-based immunoassays targeting Neutrophil Elastase (NE) and Proteinase 3, as biomarkers of lung infection and inflammation in chronic respiratory diseases such as COPD, cystic fibrosis and bronchiectasis.
This technology has been translated into a point-of-care test (NEATstik®), to enable ongoing monitoring of active NE levels. Recently published data has shown that measuring active NE levels using NEATstik® enables identification of patients with airway bacterial infection and those patients at highest risk of suffering pulmonary exacerbations over the subsequent 12 months.
In addition to proteases, the company also has significant expertise in the measurement of other inflammatory biomarkers, including IL-6, IL-8 and TNF-alpha. Grant-funded R&D funded projects for a variety of targets remain a key area of focus.
Aside from the provision of assays, ProAxsis can offer sample analysis at its purpose-built laboratory facility in Belfast and is currently supporting a number of pharmaceutical company-sponsored Phase I, II and III clinical trials.
ProAxsis is a wholly owned subsidiary of NetScientific Plc.