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® and pre|CISION™ platforms, is pleased to announce that the Declaration of Conformity for CE mark of its AffiDX® 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® 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® 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® 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® 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® 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).
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® 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 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 ® SARS-CoV-2 Lateral Flow Rapid Antigen Test and an AffiDX ® BAMS™ 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™ 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™ platform. Avacta continues to actively seek to license its proprietary platforms in a range of therapeutic areas.
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