Regulatory News:

Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces the launch of its research-use-only (RUO) polymerase chain reaction (PCR) test for a new strain of COVID-19 and the development of two new RUO PCR tests for avian influenza following recent outbreaks across Europe.


Further to the announcement on 16 November 2020, Novacyt has launched the first RUO PCR test for a specific new mutation of the SARS-CoV-2 virus, known as Y453F. Originally found in mink in Denmark and The Netherlands, the Y453F mutation quickly spread to humans and has also been detected outside of Europe1.

The mutation is of potential concern to scientists and clinicians as it causes an amino acid change which affects antibody binding. The Company believes this could have implications for vaccine strategies, which are predicated on stimulating a defined antibody response to the virus2. While it is unknown what, if any, impact the amino acid modification will have on vaccines, Novacyt believes a RUO test could help scientists and clinicians to identify patients that carry the virus with the Y453F mutation. Should a clinical need arise for the diagnostic differentiation of Y453F from other strains of COVID-19 infection, Novacyt is well positioned to offer this as a clinical use diagnostic product. The RUO product is immediately available to order.



Avian influenza

Novacyt has also taken the strategic decision to develop two new RUO PCR tests for avian influenza amid recent outbreaks. The European Centre for Disease Prevention and Control has announced that since October 2020, multiple European countries, including the UK and France, have reported outbreaks for highly pathogenic avian influenza (HPAI) viruses. Three different subtypes of HPAI viruses have been identified in wild birds and poultry, including A(H5N8), A(H5N5) and A(H5N1), with A(H5N8) being the most common.

Given the expected movements of both migratory and resident wild birds in Europe during winter, there is a high risk of further spread of the HPAI A(H5) viruses, in particular to poultry3. This has already been seen in the UK, resulting in the culling of thousands of turkeys with the H5N8 strain, including in North Yorkshire and West Norfolk.

While no human infection due to these viruses has so far been detected and the threat to the general population is currently low, continued surveillance of avian influenza viruses in Europe is important to monitor virus evolution and emergence3. As a result, Novacyt has developed two RUO PCR tests to assist in the current outbreaks. These include a test to detect all HPAI A(H5) subtypes and a test designed to confirm the specific presence of the HPAI A(H5N8) subtype, which has been at the centre of the current outbreaks. Both tests can be run on the Company’s mobile PCR testing instruments, q16 and q32, as well as on central laboratory-based PCR machines. Both RUO products are immediately available to order.


Graham Mullis, Chief Executive Officer of Novacyt, commented:

“Novacyt has long been at the forefront of rapidly developing tests to assist with the diagnosis and monitoring of emerging infectious disease threats. We continue to demonstrate this market intelligence and expertise with the development of these new RUO products to support scientists and clinicians around the world, as well as expanding our portfolio.”

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.

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