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

R&D Update

Regulatory News:

Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces an R&D update.

R&D highlights

• Launch of near-patient (mobile) testing, which comprises Novacyt’s COVID-19 test, direct-to-PCR RNA extraction kit (Exsig Direct), and q16 and q32 instruments
• Launch of a saliva sampling type to support ease of patient sampling, lower levels of discomfort and demonstrate more reproducible data
• Development of a respiratory testing panel to diagnose and distinguish between influenza A&B, RSV and COVID-19. Launch expected during September 2020 for the 2020/21 flu season in the Northern hemisphere
• Development of a two-gene test to address markets employing this testing approach. Launch expected no later than September 2020
• Development, together with a partner, of a serology (antibody) test to detect past infection of COVID-19. Launch expected in Q4 2020

The Company’s COVID-19 polymerase chain reaction (PCR) test was one of the first to be developed and registered under the CE-IVD Directive, establishing Novacyt as a pioneer and a leader in COVID-19 diagnostics. The success of the product has been built around robust design principles and the selection of a gene target that has so far demonstrated exceedingly low levels of genetic mutation and variation. To date, the target has been analysed against 42,655 individual COVID-19 viral sequences and demonstrated 100% detection.

Novacyt remains committed to building on this innovative position for COVID-19 testing, and more broadly for respiratory disease testing, and investing to address unmet needs in the market. The Company has already launched three new innovative products, Exsig Direct, Exsig Mag and COVID-HT, to support laboratories testing for COVID-19 through improving workflow efficiency and helping to address the reported shortfall in global manufacturing and supply of extraction reagents.

Scientists at the Company continue to innovate and detailed below is an update on the current development activities, which are expected to drive incremental revenue for the Company once launched. Novacyt continues to build on its patent portfolio through new filings to protect its products and market leading position in COVID-19 testing.

Launch of near-patient (mobile) testing

Further to the Company announcement on 22 July 2020, Novacyt confirms the launch of its near-patient testing (NPT) system for COVID-19. Validation of the NPT system includes analysis of over 400 patient samples carried out by a leading, accredited clinical laboratory. The reported sensitivity and specificity are both greater than 99%.