The partnership will work towards CE marking of Aptamer Group’s AptaDx SARS-CoV-2 lateral flow rapid antigen test for professional use, to detect the SARS-CoV-2 spike protein antigen in anterior nasal swabs. Initial test analysis with laboratory samples has demonstrated excellent sensitivity being able to detect as little as 1000 virus particles per mL, with further clinical validation to support the CE marking to be performed at the Integrated COVID Hub North East in Newcastle, UK.
Testing of the Optimer reagents has shown that they recognise the original viral strain and the dominant emerging variants. These variants are the ‘Kent’ variant, B.1.1.7, the Danish variant, D614G, and the South African variant, B1.351 (also known as 501Y.V2).
Working with Mologic will help to accelerate the development of Aptamer Group’s test to market and provide Aptamer Group with manufacturing capacity through Mologic, in addition to other partners, for the final commercialized test. Aptamer Group is involved in ongoing discussions with other global manufacturers to access additional capacity for the delivery of several million tests per month.
Aptamer Group’s SARS-CoV-2 rapid antigen test will be the first aptamer-based diagnostic test to be commercialised. Aptamers are synthetic nucleic acid-based affinity reagents, produced by solid phase synthesis offering simple, scalable, and highly cost-effective affinity solutions. The production of aptamers compared to standard protein-based affinity reagents offer significant cost advantages, allowing large scale development and delivery of tests globally, including to low- and middle-income countries.
Further updates will be provided following the completion of the clinical evaluation of the test performance.
Dr Arron Tolley, CEO of Aptamer Group, commented: “‘Following our initial collaboration with Mologic to develop the AptaDx SARS-CoV-2 rapid antigen test over recent months, I am delighted to have now extended our partnership to progress the CE marking of Aptamer Group’s test. We have seen encouraging laboratory performance of the rapid antigen test and have demonstrated the detection of the current main SARS-CoV-2 variants. We are now keen to take the test through clinical evaluation with Newcastle’s Integrated COVID Hub to support the CE marking with Mologic. I look forward to updating the market on clinical and commercial progress in due course.”
Mark Davis, Chief Executive Officer of Mologic, said: “The agreement with Aptamer Group further demonstrates our commitment to efforts tackling the COVID-19 pandemic, globally. In doing so, Mologic and our partners are able to offer an accelerated route to market, with increased manufacturing capacities, to crucially support expanded access to these rapid test technologies.”