Approval of exsigT COVID-19 Direct test in the UK

RNS Number : 5788S

Novacyt S.A.

15 July 2022

 

Novacyt S.A.

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

Approval of exsig™ COVID-19 Direct test in the UK under CTDA legislation

Paris, France and Camberley, UK - 15 July 2022 - Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces that the Company's exsig™ COVID-19 Direct Real-Time PCR test has been approved in the UK under the UK Health Security Agency's Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 ("CTDA").

The exsig™ COVID-19 Direct Real-Time PCR test is designed to detect a SARS-CoV-2 gene target within ORF1ab and, as with all the Company's direct-to-PCR products, removes the need for manual or automated extraction solutions to significantly improve laboratory workflow and reduce costs. In addition, the test is designed for use on an open platform, meaning it can be used with the Company's q16 and q32 instruments, as well as other validated systems. The test is the Company's fifth PCR product to be added to the CTDA register of approved products.

David Allmond, Group CEO of Novacyt, commented:

"To ensure Novacyt is well positioned for any future COVID-19 outbreaks, the Company continues to consolidate its portfolio. The approval of exsig™ COVID-19 Direct supports this aim, complementing the Company's existing PCR portfolio for COVID-19 testing in the UK and further reinforcing Novacyt's position as a first responder in infectious diseases."

The status of current CTDA submissions is as follows:

#	Product name	Current CTDA status
1	genesig® COVID-19 Real-Time PCR	Approved November 2021
2	PROmate® COVID-19 2G (q32)	Approved February 2022
3	PROmate ® COVID-19 1G (q32)	Approved April 2022
4	PROmate ® COVID-19 1G (q16)	Approved May 2022
5	exsig™ COVID-19 Direct	Approved July 2022
6 7 8 9	genesig ® COVID-19 3G Real-Time PCR genesig ® Real-time PCR SARS-CoV-2 Winterplex PathFlow ® COVID-19 Rapid Antigen Pro PathFlow® COVID-19 Rapid Antigen Self-Test	Pending evaluation

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Contacts

Novacyt SA

David Allmond, Chief Executive Officer

James McCarthy, 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]

Numis Securities Limited (Joint Broker)

Freddie Barnfield / James Black

[phone]

Allegra Finance (French Listing Sponsor)

Rémi Durgetto / Yannick Petit

[phone]

[e-mail] / [e-mail]

FTI Consulting (International)

Victoria Foster Mitchell / Alex Shaw

[phone]

[e-mail] / [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.co m

 

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