TIDMAVCT
RNS Number : 0838Y
Avacta Group PLC
10 May 2021
10 May 2021
Avacta Group plc
("Avacta" or "the Group")
AffiDX(R) SARS-CoV-2 Antigen Lateral Flow Test Update
Submission of Declaration of Conformity for CE mark for Avacta's
rapid antigen test
Avacta Group plc (AIM: AVCT), the developer of innovative cancer
therapies and diagnostics based on its proprietary Affimer(R) and
pre|CISION(TM) platforms, is pleased to announce that the
Declaration of Conformity for CE mark of its AffiDX(R) SARS-CoV-2
antigen rapid test for professional use has been submitted to the
Medicines and Healthcare products Regulatory Agency ("MHRA")
through the Group's partner Mologic Limited.
The Group has developed a SARS-CoV-2 antigen lateral flow test
using its Affimer(R) platform to detect the coronavirus spike
antigen and recently announced data from a clinical study on 98
positive COVID-19 samples that demonstrate excellent performance in
identifying the SARS-CoV-2 virus across a broad range of viral
loads.
These data have now been combined with stability and other
performance data and a submission of the Declaration of Conformity
for CE marking of the AffiDX(R) SARS-CoV-2 antigen lateral flow
test for professional use has now been made to the MHRA.
The Group expects to receive confirmation of the registration of
the AffiDX(R) in-vitro diagnostic device in the coming days, which
will allow the Group to immediately place the test on the
market.
Dr Alastair Smith, Chief Executive of Avacta Group
commented:
"I am absolutely delighted to have reached this significant
milestone for the Diagnostics Division and Avacta Group.
"I am very proud of the quality and performance of Avacta's
AffiDX(R) antigen test. As part of the recent clinical study the
same clinical samples were tested with two leading, commercially
available lateral flow antigen tests, and the data show that the
AffiDX(R) test had better clinical sensitivity across the range of
Ct values tested and, in particular, at lower viral loads.
"We are very excited by the potential of this high quality
SARS-CoV-2 rapid antigen test and the interest that we have
received for it from potential commercial partners, distributors
and end users. We are looking forward to receiving confirmation of
the registration from MHRA in the coming days allowing the Group to
immediately place the test on the market. "
This announcement contains information which, prior to its
disclosure, was considered inside information for the purposes of
Article 7 of Regulation (EU) No 596/2014 (MAR).
- 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
Tony Gardiner, Chief Financial Officer
Stifel Nicolaus Europe Limited (Nominated Adviser and Sole Corporate Broker) Tel: +44 (0) 207 710 7600
Nicholas Moore / Nick Adams / Fred Walsh / Ben Maddison www.stifel.com
FTI Consulting (Financial Media and IR) Tel: +44 (0) 203 727 1000
Simon Conway / Stephanie Cuthbert Avacta.LS@fticonsulting.com
Zyme Communications (Trade and Regional Media) Tel: +44 (0) 7787 502 947
Katie Odgaard katie.odgaard@zymecommunications.com
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 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 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 works with partners world-wide to
develop bespoke Affimer reagents for third party products. The
Group is also developing an in-house pipeline of Affimer-based
diagnostic assays including the AffiDX (R) SARS-CoV-2 Lateral Flow
Rapid Antigen Test and an AffiDX (R) BAMS(TM) SARS-CoV-2 Assay in
partnership with Adeptrix Inc.
Avacta's Therapeutics Division is addressing a critical gap in
current cancer treatment - the lack of a durable response to
current immunotherapies experienced by most patients. By combining
its two proprietary platforms the Group is building a wholly owned
pipeline of novel cancer therapies deigned to be effective for all
cancer patients. In 2021 Avacta will commence a phase 1
first-in-human, open label, dose-escalation and expansion study of
AVA6000 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, a partnership with ADC
Therapeutics to develop Affimer-drug conjugates 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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