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

Launch of CE-Mark test to detect multiple COVID-19 variants of concern - Seite 2

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

About N501Y and E484K mutations

The N501Y mutation is important as it leads to an increase in ACE2 binding and therefore to increased infectivity.³ This mutation has been seen in the UK, South African, and Brazilian variants and has been correlated in epidemiological studies to increase infectivity by approximately 70% and could potentially lead to an increase in mortality.^4-8 The E484K mutation is seen in all current VOC and is called an escape mutation because it helps the virus slip past the body's immune defences to evade host antibodies and may, as a result, diminish the efficacy of immunisation.^4-7,9-12

SNPsig portfolio

The table below contains details on Novacyt’s SNPsig portfolio of products, which have been launched to date or are due to launch imminently. Novacyt's bioinformatics surveillance group remains highly vigilant and, as significant new mutations are identified, these will be added to the SNPsig portfolio.

Product names	Detection profile	Format	Product code
SNPsig VariPLEX SARS-CoV-2#	20I/501Y.V1, 20H/501Y.V2, 20J/501Y.V3, 20C/S.452R, N501Y, E484K	CE-IVD, RUO	D00060
			R00137
SNPsig SARS-CoV-2 PLUS (20I/501Y.V1)#	20I/501Y.V1 and E484K	CE-IVD	D00066
SNPsig SARS-CoV-2 (20I/501Y.V1)	20I/501Y.V1