Novacyt releases new tests for Covid-19, bird flu

Clinical diagnostics company Novacyt announced the launch of its research-use-only polymerase chain reaction test for a new strain of Covid-19 on Monday, as well as the development of two new research-use0only polymerase chain reaction tests for avian influenza, following recent outbreaks across Europe.

The AIM-traded firm said the Covid-19 test was 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 had also been detected outside of Europe, the board said.

It said the mutation was of potential concern to scientists and clinicians, as it causes an amino acid change which affects antibody binding.

Novacyt said it believed that could have implications for vaccine strategies, which were predicated on stimulating a defined antibody response to the virus.

While it is unknown what, if any, impact the amino acid modification would have on vaccines, the company said it believed a research-use-only test could help scientists and clinicians identify patients that carry the virus with the Y453F mutation.

It said that, should a clinical need arise for the diagnostic differentiation of Y453F from other strains of Covid-19, Novacyt was “well-positioned” to offer it as a clinical use diagnostic product.

The company said the product was immediately available to order.

Meanwhile, Novacyt said it had also taken the “strategic decision” to develop two new tests for avian influenza, amid recent outbreaks.

The European Centre for Disease Prevention and Control had announced that, since October, multiple European countries including the UK and France had reported outbreaks for highly pathogenic avian influenza viruses.

Three different subtypes had 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, the company said there was a high risk of further spread of the HPAI A(H5) viruses, in particular to poultry.

It had 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.

Novacyt said that, while no human infection due to the viruses had so far been detected and the threat to the general population was currently low, continued surveillance of avian influenza viruses in Europe was important to monitor virus evolution and emergence.

As a result, Novacyt said it developed two tests to assist in the current outbreaks.

They included 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 was at the centre of the current outbreaks.

Both tests could be run on the company's mobile PCR testing instruments, q16 and q32, as well as on central laboratory-based PCR machines.

Both products were also immediately available to order.

“Novacyt has long been at the forefront of rapidly developing tests to assist with the diagnosis and monitoring of emerging infectious disease threats,” said chief executive officer Graham Mullis.

“We continue to demonstrate this market intelligence and expertise with the development of these new research-use-only products to support scientists and clinicians around the world, as well as expanding our portfolio.”

At 1614 GMT, shares in Novacyt were down 0.03% at 869.73p.