Novacyt S.A.

Research and Development Update - Seite 2

Launch of CE Mark COVID-HT Direct

Novacyt announces the launch of its next generation high-throughput PCR test for COVID-19 (COVID-HT Direct), which has been CE Mark approved. This follows the launch of the Company’s first high-throughput PCR test for COVID-19 (COVID-HT) in June 2020. The new test eliminates the need for automated extraction systems in a high-volume PCR laboratory, reducing processing time, cost and labour of testing by up to 30%. COVID-HT Direct is already in use at one of the UK’s Lighthouse laboratories and is being validated for use with private high-throughput PCR laboratory partners.

Development of an antibody lateral flow test for COVID-19

The Company continues to work on developing an IgG antibody lateral flow test (LFT) for use as a rapid antibody test for professional use. An LFT is an easy-to-use diagnostic device used to confirm the presence or absence of a pathogen or biomarker and takes approximately 10-20 minutes or less to provide a result.

The Company expects to launch its LFT in Q2 2021, slightly later than planned as it has taken the strategic decision to develop a next generation of LFT to detect the neutralizing antibodies generated by successful immunisation and, therefore, to assist in monitoring the effectiveness of future vaccines ³. The Company believes this exemplifies how it can extend the revenue horizon for COVID-19 as the demand for testing continues to evolve.

Development of a loop-mediated isothermal amplification COVID-19 test

Further to the announcement on 16 November 2020, the Company has completed early studies using its loop-mediated isothermal amplification (LAMP) technology with its q16 and q32 instrument platforms and open LAMP platforms and demonstrated encouraging initial results. Novacyt continues to evaluate the ongoing opportunity for LAMP testing and will launch its technology subject to demand.

Development of a new test panel to detect aspergillosis fungal infections

Aspergillosis is an infection caused by aspergillus fungus common in immune compromised patients⁴, and more recently has been associated with co-infection in patients with SARS-CoV-2⁵ infections and COVID-19–associated pulmonary aspergillosis⁶. The infection is associated with long-term ventilation of patients. Outside of SARS-CoV-2 infections, aspergillosis also remains a potentially serious respiratory infection, affecting ~5 million patients worldwide⁷.