Aptamer Group, the developer of diagnostic and therapeutic Optimer reagents, has announced a commercial partnership with Mologic, a leading developer and manufacturer of lateral flow and rapid diagnostic tests. 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 commercialised 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.