Avacta Group PLC Diagnostics achieves ISO 13485 Certification (1441F)
14 July 2021 - 4:00PM
UK Regulatory
TIDMAVCT
RNS Number : 1441F
Avacta Group PLC
14 July 2021
14 July 2021
Avacta Group plc
("Avacta" or "the Group" or "the Company")
Avacta's Diagnostic Division Achieves ISO 13485
Certification
Avacta Group plc (AIM: AVCT), the developer of diagnostics and
innovative cancer therapies based on its proprietary Affimer(R) and
pre|CISION(TM) platforms, is pleased to announce that Avacta Life
Sciences' diagnostics division has achieved ISO 13485 certification
for the quality management system for the manufacture and
distribution of Affimer(R) reagents for use in lateral flow, ELISA
and immunodiagnostic in-vitro diagnostic devices.
The ISO 13485 standard defines the comprehensive requirements
for quality management for a developer and legal manufacturer of
diagnostic products and medical devices. The certification, which
provides a practical foundation for Avacta to address the
regulatory requirements and ensure the safety and quality of its
products, follows after having successfully passed the audit by the
Avacta's Notified Body (BSI Group) of the Company's quality
management system in April 2021.
ISO 13485 certification means that the CE mark for the AffiDX(R)
SARS-CoV-2 antigen lateral flow test can be transferred to Avacta
from its partner, Mologic, and Avacta will be legal manufacturer of
all future in-vitro diagnostic products.
Dr Alastair Smith, Chief Executive Officer of Avacta Group,
commented:
"We are delighted that Avacta's diagnostics division has
achieved ISO 13485 certification. The team have delivered excellent
systems, processes and practices that now make up our quality
framework, supporting the future growth and commercial success of
the company.
"ISO 13485 certification is recognised globally by our partners,
customers and regulatory bodies alike as the medical device
industry benchmark for quality. This certification marks a major
milestone for Avacta and underpins the product development strategy
for the future of our diagnostics division."
-Ends -
For further information from Avacta Group plc, please
contact:
Avacta Group plc
Alastair Smith, Chief Executive Tel: +44 (0) 844 414 0452
Officer www.avacta.com
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 / Stephanie Cuthbert
Zyme Communications (Trade and Tel: +44 (0)7787 502 947
Regional Media) katie.odgaard@zymecommunications.com
Katie Odgaard
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 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(R) 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 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.
To register for news alerts by email go to www.avacta.com/investor-news-email-alerts
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
MSCRJMBTMTIBTTB
(END) Dow Jones Newswires
July 14, 2021 02:00 ET (06:00 GMT)
Avacta (LSE:AVCT)
Historical Stock Chart
From Apr 2024 to May 2024
Avacta (LSE:AVCT)
Historical Stock Chart
From May 2023 to May 2024