Novacyt Regulatory News (NCYT)

Novacyt S.A.

("Novacyt", the "Company" or the "Group")

2,000 patient clinical trial using Novacyt's near-patient testing system initiated in London care homes

Paris, France and Camberley, UK - 22 July 2020 - Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, notes the initiation of a clinical trial by Queen Mary University of London using the Company's innovative near-patient testing system. The study is investigating whether daily COVID-19 testing reduces the infection rate, morbidity and mortality in the high-risk care home population.

The randomised clinical trial, recruiting up to 2,000 residents in 50 care homes across east London, is being led by Professor Jo Martin, President of the Royal College of Pathologists and Professor of Pathology at Queen Mary University of London. The study is using a mobile or near-patient testing (NPT) system for COVID-19 developed by Novacyt (further detail below), which comprises the Company's COVID-19 polymerase chain reaction (PCR) test, direct-to-PCR RNA extraction kit (exsig™ Direct), and portable testing instruments (Q16 and Q32 instruments), to ensure reliable results are received within an hour of testing.

The clinical trial team comprises researchers, medical students and laboratory experts from Queen Mary and Novacyt. Daily testing, using Novacyt's NPT system, is being trialled for residents, staff and visitors in 25 care homes. As the comparator, the other 25 care homes will receive standard central laboratory testing once a week.

As part of the clinical trial, the effectiveness of mid-nose nasal swabs compared to invasive nasopharyngeal swabs will be evaluated to support ease of use, lower levels of discomfort and demonstrate more reproducible data.

Professor Jo Martin, Professor of Pathology at Queen Mary University of London, and lead investigator of the study, commented:

"This work has the potential to bring a new rapid COVID-19 testing system to those at highest risk and help interrupt community transmission. If found to be successful in care homes, it could be very useful in a wide range of settings, helping to make a quick diagnosis and keep an environment free of COVID-19.

"With rapid daily testing, we can report back to the care home on the same day, so that they can take action to reduce transmission in their care home and prevent outbreaks into the wider community. By undertaking this study in the diverse East London community, we're hoping to protect one of the most vulnerable groups in the UK, and the frontline staff who are caring for them."

Graham Mullis, Group CEO of Novacyt, added:

"We are delighted to be working with Professor Jo Martin and her expert team at Queen Mary University of London to complete this important clinical trial. We believe daily testing with our near-patient testing system, which incorporates the use of our market leading COVID-19 test, has the potential to reduce the transmission of SARS-CoV-2 in the high-risk care home population and in a wider community setting. We believe our new system increases the number of options available for rapid and reliable COVID-19 testing outside of centralised care and we expect to launch the system by the end of July 2020."

Novacyt's near-patient testing system

The Company's first COVID-19 test was designed for professional, central laboratory use only. In this format, the components of the test are supplied in specific vials which laboratory staff are required to pipette, along with the patient sample, in precise volumes, into the reaction vessel. Whilst this is customary in clinical diagnostic laboratories, for decentralised near-patient testing (NPT) settings a more direct procedure is required.

Novacyt's objective is therefore to develop a system with a reduced number of workflow steps for NPT. The Company plans to use its expertise in PCR testing to coat and stabilise the essential biological components required for its COVID-19 test onto laboratory products, such as reaction tubes. As a result, the laboratory products will be "ready-to-use" on Novacyt's q16 and q32 portable instruments and will only require the addition of a small amount of patient sample to initiate the COVID-19 test.

Also part of the NPT system is the Company's recently developed direct-to-PCR extraction kit (exsig™ Direct), which extracts RNA from patient samples and further reduces the number of workflow steps. As a result, the NPT system is ideally suited to applications in mobile settings, such as care homes, key hospital departments and other community locations. The Company expects to launch its NPT system by the end of July 2020.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.

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Contacts

Novacyt SA

Graham Mullis, Chief Executive Officer

Anthony Dyer, Chief Financial Officer

+44 (0)1276 600081

SP Angel Corporate Finance LLP (Nominated Adviser and Broker)

Matthew Johnson / Charlie Bouverat (Corporate Finance)

Vadim Alexandre / Rob Rees (Corporate Broking)

+44 (0)20 3470 0470

FTI Consulting (International)

Victoria Foster Mitchell / Mary Whittow

+44 (0)20 3727 1000

victoria.fostermitchell@fticonsulting.com / mary.whittow@fticonsulting.com 

FTI Consulting (France)

Arnaud de Cheffontaines

+33 (0)147 03 69 47

arnaud.decheffontaines@fticonsulting.com 

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