Approval of exsig COVID-19 Direct Test in the UK Under CTDA


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PARIS & CAMBERLEY, England–(BUSINESS WIRE)–
Regulatory News:

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

genesig® COVID-19 3G Real-Time PCR

 

7

genesig® Real-time PCR SARS-CoV-2 Winterplex

Pending evaluation

8

PathFlow® COVID-19 Rapid Antigen Pro

9

PathFlow® COVID-19 Rapid Antigen Self-Test

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

Novacyt SA

David Allmond, Chief Executive Officer

James McCarthy, 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

Numis Securities Limited (Joint Broker)

Freddie Barnfield / James Black

+44 (0)20 7260 1000

Allegra Finance (French Listing Sponsor)

Rémi Durgetto / Yannick Petit

+33 (1) 42 22 10 10

[email protected]/ [email protected]

FTI Consulting (International)

Victoria Foster Mitchell / Alex Shaw

+44 (0)20 3727 1000

[email protected] / [email protected] / [email protected]

FTI Consulting (France)

Arnaud de Cheffontaines

+33 (0)147 03 69 48

[email protected]

Source: Novacyt S.A.

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