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

R&D and UK Operational Update - Seite 2

Expansion of the PathFlow LFT portfolio

PathFlow SARS-CoV-2 IgG is a professional use LFT for the detection of SARS-CoV-2 IgG antibodies, launched as a CE-IVD on 31 March 2021. The test provides a rapid turnaround time of results from ten minutes and has demonstrated sensitivity of 98% and specificity of 99% in validation studies.

PathFlow SARS-CoV-2 SMART IgG is a next generation LFT to detect and, importantly, differentiate between IgG antibodies. The test is expected to assist clinicians in understanding the impact of immunisation programmes, as well as the levels of immunity derived from infection by the virus. The Company now expects to launch this test as a CE-IVD in Q3 2021.

PathFlow SARS-CoV-2 Antigen is a professional and home use LFT for the detection of SARS-CoV-2 antigens using non-invasive anterior nasal swab samples to provide a result in approximately 15 minutes. Novacyt has been working with a partner to develop this test, which is able to detect the virus regardless of current known mutations. The Company intends to launch the test as CE-IVD before the end of Q2 2021 and expects it to complement Novacyt’s established position in COVID-19 PCR testing. As the market for COVID-19 testing continues to develop, the Directors believe this product could add significant revenues for Novacyt.

Expansion of the genesig COVID-19 PCR portfolio

Following an emerging need in some countries, Novacyt has launched a CE-IVD genesig COVID-19 three-gene target test for use with nasopharyngeal, oropharyngeal and saliva sample types. This key extension to the genesig COVID-19 portfolio, alongside the one-gene and two-gene tests, is expected to be critical for use in airport test and release programmes to and from certain countries.

Expansion of the PROmate PCR portfolio

PROmate remains the only direct-to-PCR assay approved by the UK’s Technology Validation Group and enables near-to-patient testing with results in under 90 minutes. The current CE-IVD PROmate COVID-19 test identifies the SARS-CoV-2 ORF1ab gene. Due to an emerging need in some countries, the Company expects to launch a second CE-IVD PROmate COVID-19 test in May 2021 to identify both the SARS-CoV-2 ORF1ab gene and M gene.

In addition, Novacyt has launched PROmate SARS-CoV-2 E484K, a research-use-only (RUO) test to identify this key mutation, with a CE-IVD planned subject to demand. E484K is a mutation found in all current VOC and has been associated with immune evasion and reduction of vaccine efficacy.