Novacyt S.A. ("Novacyt", the "Company" or the "Group")

R&D and UK Operational Update

Regulatory News:

Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces an update on the progress of its near-term COVID-19 research and development (R&D) programmes to address rapidly evolving testing demands, particularly as SARS-CoV-2 continues to mutate around the world. Novacyt also provides an update on its UK operations.

R&D highlights

• Expansion of PathFlow lateral flow test (LFT) portfolio with COVID-19 tests
  • Launch of LFT to detect SARS-CoV-2 IgG antibodies
  • Development of LFT to detect and differentiate between SARS-CoV-2 IgG antibodies, launch expected Q3 2021
  • Development of LFT to detect antigens for SARS-CoV-2, launch expected by end of Q2 2021
• Expansion of genesig COVID-19 polymerase chain reaction (PCR) portfolio
  • Launch of CE Mark three-gene target PCR test
• Expansion of PROmate COVID-19 PCR portfolio for workflow efficiency in a near-to-patient setting
  • Development of two-gene target test, launch expected May 2021
  • Launch of test to identify a key mutation, E484K, found in all current variants of concern (VOC)
• Expansion of SNPsig COVID-19 PCR genotyping portfolio to detect SARS-CoV-2 variants
  • Launch of CE Mark VariPLEX assay panel to detect multiple variants
  • Development of test to detect a variant originally identified in India, launch expected week commencing 26 April 2021

UK operational highlights

• Expansion of UK commercial infrastructure
• Inclusion in Public Health England (PHE) National Framework Agreement

Graham Mullis, Chief Executive Officer of Novacyt, commented:

“The continued development and expansion of our COVID-19 portfolio demonstrates Novacyt’s ability to match the rapid evolution of SARS-CoV-2 with real-time bioinformatics surveillance and accelerated product development. We remain committed to identifying patient needs and overcoming healthcare challenges today and in the years ahead as we continue to strengthen our position as a leading innovator in diagnostic testing.

“We are also pleased to be included in the PHE national framework, which allows PHE and NHS hospitals to purchase our accredited products without the need for direct contract awards. We look forward to the opportunity to expand our support of diagnostic testing in the UK through our established infrastructure and building a long-term future in this important market, as well as in international markets as we continue to invest in our direct commercial operations.”