REG - Avacta Group PLC - AffiDX Receives CE Mark for Consumer Self-Testing

AvactaAnnouncement

22/12/2021 07:00

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RNS Number : 4176W  Avacta Group PLC  22 December 2021

 

22 December 2021

 

Avacta Group plc

 

("Avacta" or "the Group" or "the Company")

 

AffiDX(®) SARS-CoV-2 Antigen Lateral Flow Test Receives CE Mark for Consumer
Self-Testing

 

Avacta Group plc (AIM: AVCT), a clinical stage biopharmaceutical company
developing innovative cancer therapies and powerful diagnostics based on its
proprietary Affimer(®) and pre|CISION™ platforms, announces that the
AffiDX(®) SARS-CoV-2 antigen lateral flow test has received a CE mark for use
as a consumer self-test in the UK and EU.

 

Avacta partnered with Medusa Healthcare ("Medusa") to obtain regulatory
approval for the AffiDX(®) antigen test for consumer self-testing and has now
received the CE mark from a European Notified Body. Avacta has an exclusive
arrangement with Medusa to commercialise the consumer self-test product
globally.

 

The AffiDX(®) SARS-CoV-2 antigen lateral flow self-test will be marketed by
Medusa under the brand name "MeduFlow".

 

The AffiDX(®) SARS-CoV-2 antigen lateral flow test has been developed using
Avacta's proprietary Affimer(®) platform to identify individuals with a
higher viral load of the SARS-CoV-2 virus who are therefore more likely to
infect others. The test, which uses a simple, patient friendly nasal swab and
gives a result in 20 minutes, has been independently clinically validated at
the Carlos III hospital in Madrid and shown to have a sensitivity across a
broad range of viral loads of 98% and a specificity of 99%. The AffiDX(®)
antigen lateral flow test was CE marked for professional use in the UK and EU
in June 2021

 

Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented:

"This is an extremely important step forwards in the commercialisation of the
AffiDX(®) antigen test. As the pandemic progresses, the global antigen
testing market is moving away from professional use antigen tests with
increasing adoption of self-test products.

 

"The AffiDX(®) test is the first UK-developed SARS-CoV-2 antigen test that
has received a CE mark for self-testing which, coupled with the fact that it
is based on innovative UK technology and is manufactured in the UK are
important selling points for customers in the UK, EU and elsewhere.

 

"Our partners at Medusa have rapidly obtained regulatory approval, and we look
forward to working closely with them to provide consumers with reliable, high
quality tests that address this substantial market."

 

ENDS

 

For further information from Avacta Group plc, please contact:

 

 Avacta Group plc                                          Tel: +44 (0) 844 414 0452

 Alastair Smith, Chief Executive Officer                   www.avacta.com (http://www.avacta.com)

 Tony Gardiner, Chief Financial Officer

 Michael Vinegrad, Group Communications Director

 Stifel Nicolaus Europe Limited (Nomad and Broker)         Tel: +44 (0) 207 710 7600

 Nicholas Moore / Nick Adams / Fred Walsh / Ben Maddison   www.stifel.com (http://www.stifel.com/)

 FTI Consulting (Financial Media and IR)                   Tel: +44(0) 203 727 1000

 Simon Conway / Alex Shaw/ Stephanie Cuthbert              Avacta.LS@fticonsulting.com (mailto:Avacta.LS@fticonsulting.com)

 Zyme Communications (Trade and Regional Media)            Tel: +44 (0)7891 477 378

 Lily Jeffery                                              lily.jeffery@zymecommunications.com

                                                         (mailto:katie.odgaard@zymecommunications.com)

 

About Avacta Group plc - https://www.avacta.com (https://www.avacta.com/)

 

Avacta Group is developing novel cancer immunotherapies and powerful
diagnostics based on its two proprietary platforms - Affimer(®) biologics and
pre|CISION™ tumour targeted chemotherapies.

 

The Affimer(®) platform is an alternative to antibodies derived from a small
human protein. Despite their shortcomings, antibodies currently dominate
markets, such as diagnostics and therapeutics, worth in excess of $100bn.
Affimer(®) technology has been designed to address many of these negative
performance issues, principally: the time taken to generate new antibodies and
the reliance on an animal's immune response; poor specificity in many cases;
their large size, complexity and high cost of manufacture.

 

Avacta's pre|CISION™ targeted chemotherapy platform releases active
chemotherapy in the tumour, which limits the systemic exposure that causes
damage to healthy tissues, and thereby improves the overall safety and
therapeutic potential of these powerful anti-cancer treatments.

 

The Group comprises two divisions: The therapeutics development activities are
based in London and Cambridge, UK and the Group is generating near-term
revenues from Affimer(®) reagents for diagnostics, bioprocessing and
research, through a separate diagnostics business unit based in Wetherby, UK.

 

Avacta's Diagnostics Division is developing an in-house pipeline of
Affimer-based diagnostic assays, including the AffiDX(®) SARS-CoV-2 Lateral
Flow Rapid Antigen Test, and works with partners world-wide to develop bespoke
Affimer(®) reagents for third party products.

 

Avacta's Therapeutics Division is working to deliver a more tolerable and
durable treatment response for oncology patients who do not respond to
existing immunotherapies. By combining its two proprietary platforms the Group
is building a wholly owned pipeline of clinically differentiated cancer
therapies, aiming to extend the therapeutic benefits to all cancer patients.
In 2021 Avacta transitioned to become a clinical stage biopharmaceutical
company, commencing a phase I first-in-human, open label, dose-escalation and
expansion study of AVA6000, a pro-doxorubicin, the Group's lead pre|CISION™
prodrug, in patients with locally advanced or metastatic selected solid
tumours.

 

Avacta has established drug development partnerships with pharma and biotech,
including a research collaboration with ModernaTX, Inc. (formerly Moderna
Therapeutics Inc.), a multi-target deal with LG Chem worth up to $400m, a
joint venture in South Korea with Daewoong Pharmaceutical focused on cell and
gene therapies incorporating Affimer immune-modulators and a collaboration
with Point Biopharma to develop radiopharmaceuticals based on the
pre|CISION™ platform. Avacta continues to actively seek to license its
proprietary platforms in a range of therapeutic areas.

 

To register for news alerts by email go
to www.avacta.com/investor-news-email-alerts
(http://www.avacta.com/investor-news-email-alerts)

 

About Medusa Healthcare - www.medusa19.com (http://www.medusa19.com)

Medusa Healthcare, a subsidiary of Medusa 19, has recently been established by
Richard Hughes and Mahmud Kamani, who were both founder shareholders of
Boohoo.com, with the objective of building a global "Business to Consumer"
("B2C") medical diagnostics business. In addition, Richard was the founder of
Crawford Healthcare Limited and Zeus Capital Limited. The founders have
extensive experience in multi-country/global e-commerce, marketing,
fulfilment, manufacture and logistics.

 

For further information contact:

Stuart King

stuart.king@medusa19.com (mailto:stuart.king@medusa19.com)

 

Buchanan Communications (Media Relations for Medusa19)

Richard Oldworth, Henry Harrison-Topham, Jamie Hooper

Tel: +44 (0)7710 130 634

medusa19@buchanan.uk.com (mailto:medusa19@buchanan.uk.com)

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