COVID-19 diagnostic regulatory update

RNS Number : 8174I

Novacyt S.A.

06 April 2020

 

Novacyt S.A.

("Novacyt" or the "Company")

COVID-19 diagnostic regulatory update

CNR (Institut Pasteur) approval in France

Ministry of Health approval in Thailand

Paris, France and Camberley, UK - 6 April 2020 -   Novacyt ( EURONEXT GROWTH: ALNOV; AIM: NCYT ), an international specialist in clinical diagnostics, announces that the CNR (Centre National de Référence des Virus des Infections Respiratoires (dont la grippe)) of the Institut Pasteur, an internationally renowned centre for biomedical research with a goal of improving public health in France, has approved its COVID-19 test. The Company's CE-Mark test is available for immediate distribution into the French market.

On 2 April 2020, Novacyt also received approval for its COVID-19 test from the Ministry of Health in Thailand.

Graham Mullis, Chief Executive Officer of Novacyt, commented:  

"As an Anglo-French company, I am delighted that Novacyt is able to support both of its domestic markets in tackling this pandemic. The Institut Pasteur's evaluation and approval of our COVID-19 test is an important validation and I am grateful to Atothis, our distribution partner in France, for its efforts in working with the centre. We look forward to suppo rting the French authorities in their COVID-19 testing requirements. "

The Primerdesign COVID-19 test has received accreditation from a number of leading global regulatory authorities, including Public Health England and the US Food and Drug Administration. In addition to the test currently being approved in the UK, the US, France, India, the Philippines, Argentina and Thailand, it is available in markets which directly accept CE-Mark accreditation without the need for further approval.

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

[phone]

SP Angel Corporate Finance LLP (Nominated Adviser and Broker)

Matthew Johnson / Charlie Bouverat (Corporate Finance)

Vadim Alexandre / Rob Rees (Corporate Broking)

[phone]

FTI Consulting (International)

Victoria Foster Mitchell / Mary Whittow

[phone]

[e-mail] / [e-mail]  

FTI Consulting (France)

Arnaud de Cheffontaines

[phone]

[e-mail]  

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 COVID-19

Researchers at the Chinese Centre for Disease Control and Prevention and their collaborators have sequenced the 2019 novel coronavirus (COVID-19) pathogen from patient samples and have found it to be genetically distinct from the severe acute respiratory syndrome (SARS) virus that caused an epidemic in 2002 and 2003, as well as from the Middle East respiratory syndrome (MERS) virus that was detected in 2012.  

 

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