Avacta Group PLC Update on UK Availability of AffiDX Test (9950Q)
02 November 2021 - 6:00PM
UK Regulatory
TIDMAVCT
RNS Number : 9950Q
Avacta Group PLC
02 November 2021
2 November 2021
Avacta Group plc
("Avacta" or "the Group" or "the Company")
Update on UK Availability of AffiDX SARS-CoV-2 Lateral Flow
Rapid Antigen Test following Implementation of CTDA Regulations
Avacta Group plc (AIM: AVCT), a clinical stage biopharmaceutical
company developing innovative cancer therapies and powerful
diagnostics based on its proprietary Affimer(R) and pre|CISION(TM)
platforms, notes that, as of 1 November 2021, the UK Health
Security Agency's Medical Devices (Coronavirus Test Device
Approvals) (Amendment) Regulations 2021 ("CTDA regulations") have
come into force. Consistent with these new regulations the Company
has suspended, as of 1 November 2021, further sales of its AffiDX
SARS-CoV-2 Lateral Flow Rapid Antigen Test in the UK until the
ongoing desktop evaluation of the test has been successfully
completed by the Agency and the test subsequently is put on the
CTDA register for approved products. This is a new requirement for
the supply of any COVID-19 test in the UK and is over and above the
CE mark and successful registration of Company's AffiDX test with
the MHRA which was announced on 7 June 2021.
The new CTDA Regulations stipulate that all suppliers of
COVID-19 tests must submit information regarding their products for
desktop review if they wish to remain on sale in the UK. As of 1
November 2021, there were only three products for which the Agency
had completed its desktop review listed on the CTDA register for
approved products. Additionally, the UK Health Security Agency has
published a temporary protocol which lists 48 tests (both PCR and
antigen based) which passed the Public Health England validation
process at Porton Down earlier in the year that can remain
available for sale in the UK whilst their validation is completed
until a cut-off date of 28 February 2022.
Avacta submitted, ahead of the 1 September 2021 deadline, all
the information required for its AffiDX test to be validated under
these regulations by the UK Health Security Agency, and the Company
has paid the required fee. The Company awaits further notification
from the UK Health Security Agency when it completes its review of
the information supplied for the AffiDX SARS-CoV-2 Lateral Flow
Rapid Antigen Test.
The impact of suspension of sales in the UK as a result of the
CTDA regulations coming into force will not have a material impact
on the Company's anticipated financial outturn for the financial
year ending 31 December 2021. As previously noted, Avacta continues
to focus on opportunities outside of the UK for the sale and
marketing of its AffiDX SARS-CoV-2 Lateral Flow Rapid Antigen Test
including markets in Europe and further afield.
- Ends -
For further information from Avacta Group plc, please
contact:
Avacta Group plc Tel: +44 (0) 844 414 0452
Alastair Smith, Chief Executive www.avacta.com
Officer
Tony Gardiner, Chief Financial Officer
Michael Vinegrad, Group Communications
Director
Stifel Nicolaus Europe Limited (Nomad Tel: +44 (0) 207 710 7600
and Broker) www.stifel.com
Nicholas Moore / Nick Adams / Fred
Walsh / Ben Maddison
FTI Consulting (Financial Media Tel: +44(0) 203 727 1000
and IR) Avacta.LS@fticonsulting.com
Simon Conway / Alex Shaw / Stephanie
Cuthbert
Zyme Communications (Trade and Tel: +44 (0)7891 477 378
Regional Media) lily.jeffery@zymecommunications.com
Lily Jeffery
About Avacta Group plc - https://www.avacta.com
Avacta Group is developing novel cancer immunotherapies and
powerful diagnostics based on its two proprietary platforms -
Affimer(R) biologics and pre|CISION(TM) tumour targeted
chemotherapies.
The Affimer(R) 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(TM) 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(R)
SARS-CoV-2 Lateral Flow Rapid Antigen Test, and works with partners
world-wide to develop bespoke Affimer(R) 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(TM) 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(TM) platform. Avacta continues to actively seek to
license its proprietary platforms in a range of therapeutic
areas.
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