Partnership to provide Accelerated Pathway for Antigen Test

A partnership between Aptamer Group, developers of diagnostic and therapeutic Optimer™ reagents and  Mologic, a leading developer and manufacturer of lateral flow and rapid diagnostic tests, will work towards CE marking of Aptamer Group’s AptaDx SARS-CoV-2 lateral flow rapid test to detect the SARS-CoV-2 spike protein antigen in anterior nasal swabs. Clinical validation to support the CE marking will be carried out 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).

As well as accelerating development of the test, Mologic will also provide Aptamer Group with manufacturing capacity in addition to other partners, for the final commercialised test. There are also ongoing discussions with other global manufacturers to provide access to additional capacity to meet delivery of several million tests per month.

Aptamers are synthetic nucleic acid-based affinity reagents, produced by solid phase synthesis offering simple, scalable 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.

Dr Arron Tolley, CEO 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.”

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