Regulatory News:

Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces the expansion of its VersaLab™ service with the launch of mobile processing laboratories (MPL) to provide rapid turnaround polymerase chain reaction (PCR) testing on-site. Testing will be performed using mid-nose nasal swabs, which were found to be effective and well tolerated compared to the more invasive nasopharyngeal swabs in the interim review of Queen Mary University of London’s clinical trial in care homes, as announced by the Company on 16 November 2020.

VersaLab™ was launched in December 2020 to support private sector testing of infectious diseases, initially focused on COVID-19. This has enabled Novacyt to identify a growing number of UK and international mobile testing opportunities across the private sector.

Novacyt’s MPLs will be fully equipped with its PROmate™ assay and q16 PCR instruments. PROmate™ is the only direct-to-PCR COVID-19 assay approved by the Department of Health and Social Care’s Technology Validation Group. The PROmate™ workflow, which includes a viral inactivation buffer, means the MPLs do not require a category 2 laboratory to handle the live virus. As a result, the cost of testing is reduced, as well as the risks associated with handling the live virus in a mobile testing unit. This workflow allows Novacyt to provide rapid results to patients in under 80 minutes. Novacyt is one of the first companies to offer mobile testing units to deliver same day, on-site results using the gold standard sensitivity and specificity of PCR technology.

With an active pipeline of opportunities, Novacyt believes the addition of VersaLab™ MPLs could offer new long-term revenue growth opportunities as the private sector begins to take control of COVID-19 testing to keep businesses open and running efficiently. Novacyt is trialling the MPLs with several private testing partners (approved customers of the government “test-to-release” scheme) at various sites in the UK to support international travel.

Each MPL is able to process up to 900 COVID-19 samples per day, depending on customer needs. This throughput model supports multiple use cases such as on-site testing at workplaces, schools, sporting and music events.

Novacyt is also in the process of validating the use of its SNPsig® portfolio with PROmate™ to enable a mobile workflow solution that can detect the original SARS-CoV-2 strain and identify variants of concern to support healthcare providers rapidly identify the outbreak of surge infections in localised areas.

Graham Mullis, Chief Executive Officer of Novacyt, commented:

“Throughout the COVID-19 pandemic, Novacyt has focused on innovation to ensure we adapt in line with a rapidly evolving market. The roll-out of our VersaLab™ MPL units is an exciting development for Novacyt, as we continue to bring PCR technology outside of the central laboratory and closer to patients. We believe this option provides companies and communities with reliable and fast turnaround results to deal with localised surge infections or for routine localised mass testing. The need for localised community testing and monitoring of COVID-19 infections looks set to continue over the next 12 months and it is our view that much of this testing could be undertaken by the private sector. Novacyt is therefore well-placed to support this growth opportunity.”

About Novacyt Group

The Novacyt Group is an international diagnostics business generating an increasing portfolio of in vitro and molecular diagnostic tests. Its core strengths lie in diagnostics product development, commercialisation, contract design and manufacturing. The Company's lead business units comprise of Primerdesign and Lab21 Products, supplying an extensive range of high-quality assays and reagents worldwide. The Group directly serves microbiology, haematology and serology markets as do its global partners, which include major corporates.

For more information please refer to the website: www.novacyt.com