Aptamer Group and Mologic enter commercial partnership to develop aptamer-based SARS-CoV-2 rapid antigen test

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Aptamer Group, the developer of diagnostic and therapeutic Optimer reagents, 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 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.”

Aptamer Group is a world-leading provider of Optimer™ reagents for use in research, diagnostics and therapeutics. The Company strives to deliver transformational solutions, that meet the needs of researchers and developers across the life sciences through the use of its proprietary Optimer technology.

Optimers are next-generation aptamer molecules derived from nucleic acids that function as an antibody alternative. Despite many well-recognised problems with antibodies, the global antibody market is currently worth over $130Bn. Optimers are engineered to address many of the issues found with alternative affinity molecules, such as antibodies, and offer new, innovative solutions to bioprocessing, diagnostic and pharmaceutical scientists.

At Aptamer Group, we have successfully delivered projects for global pharma companies, diagnostic development companies, and research institutes covering a range of targets and applications with the objective of establishing royalty-bearing licenses. Through our unique technology and processes, we enable scientists and collaborators to make faster, more informed decisions that support discovery and development across the Life Sciences.

Mologic is a leading developer of advanced lateral flow and rapid diagnostic technologies. Leveraging its core technology platforms, the Company works with global organisations, researchers and clinicians to help them deliver fast, reliable and accurate diagnosis at the point-of-need. Mologic’s founder, Professor Paul Davis, was one of the co-inventors of the Clearblue pregnancy test that was launched in 1988 as the world’s first commercial application of lateral flow technology. The creativity, insight and knowledge that led to that ground-breaking invention has guided Mologic since its formation in 2003.

Mologic offers world-leading technology and scientific research expertise for contract research and development, alongside a portfolio of device and reagent products for clinical applications. The Company also helps organisations to scale-up manufacturing from initial prototyping through low to mid-scale production. Mologic’s science has broad application across markets and disease states where rapid, accurate point-of-need testing can help make a difference in patient care and patient outcomes.

Clients include the Bill & Melinda Gates Foundation where Mologic is leveraging core technology through its Centre for Advanced Rapid Diagnostics (CARD) to develop the next-generation of ultra-sensitive point-of-need diagnostics which are easy to use and low cost to manufacture – critical to the success of many global health programmes.

The Company is actively seeking strategic partners for its internal pipeline of respiratory, infectious disease and women’s health diagnostics.

Mologic is headquartered in Bedford in the United Kingdom and has a US subsidiary in the greater Boston area, MA, USA.