LSE:AVCT

Avacta’s Diagnostic Division Achieves ISO 13485 Certification

Wednesday, July 14, 2021 - 9:16am

The ISO 13485 standard defines the comprehensive requirements for quality management for a developer and legal manufacturer of diagnostic products and medical devices.

Key Points: 
  • The ISO 13485 standard defines the comprehensive requirements for quality management for a developer and legal manufacturer of diagnostic products and medical devices.
  • ISO 13485 certification means that the CE mark for the AffiDX 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 Avactas diagnostics division has achieved ISO 13485 certification.
  • ISO 13485 certification is recognised globally by our partners, customers and regulatory bodies alike as the medical device industry benchmark for quality.

Avacta Announces AffiDX® SARS-CoV-2 Antigen Lateral Flow Test Detects Delta Variant

Tuesday, June 29, 2021 - 10:36am

Avacta Group plc (AIM: AVCT), the developer of diagnostics and innovative cancer therapies based on its proprietary Affimer and pre|CISION platforms, is pleased to announce that a study has shown that the AffiDX antigen lateral flow test detects the Delta variant of the SARS-CoV-2 virus in clinical samples and, in this small study, outperformed two lateral flow antigen tests that are commercially available in Europe.

Key Points: 
  • Avacta Group plc (AIM: AVCT), the developer of diagnostics and innovative cancer therapies based on its proprietary Affimer and pre|CISION platforms, is pleased to announce that a study has shown that the AffiDX antigen lateral flow test detects the Delta variant of the SARS-CoV-2 virus in clinical samples and, in this small study, outperformed two lateral flow antigen tests that are commercially available in Europe.
  • The AffiDX SARS-CoV-2 antigen lateral flow test has been evaluated with a small number of patient samples confirmed to be Delta variant positive and, for a Ct
  • The AffiDX SARS-CoV-2 antigen lateral flow test is CE marked for professional use in the UK and EU.
  • Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented: We are delighted to report that the AffiDX SARS-CoV-2 antigen lateral flow test detects the Delta variant with very high sensitivity for patients with a Ct value of less than 29.

Avacta Announces AffiDX® SARS-CoV-2 Antigen Lateral Flow Test Distribution Agreement

Monday, June 21, 2021 - 9:56am

The non-exclusive distribution agreement for Avactas AffiDX SARS-CoV-2 antigen lateral flow test for professional use covers the UK and EEA.

Key Points: 
  • The non-exclusive distribution agreement for Avactas AffiDX SARS-CoV-2 antigen lateral flow test for professional use covers the UK and EEA.
  • Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented: We are delighted that we have put in place this distribution agreement for the AffiDX SARS-CoV-2 antigen lateral flow test for professional use with Calibre.
  • Avacta will continue to focus on developing direct sales opportunities to major corporates and other large scale end users.
  • Lateral flow tests have a crucial role to play in helping societies and the global economy return to normal and Avactas AffiDX antigen test, developed in the UK and based on UK technology is well placed to play a significant role in this process.

Avacta Announces Registration of its AffiDX SARS-CoV-2 Antigen Lateral Flow Test in EU

Friday, June 11, 2021 - 12:25pm

Lateral flow antigen tests are intended to provide a cost effective and rapid means of identifying individuals with a high viral load that means they are more likely to infect others.

Key Points: 
  • Lateral flow antigen tests are intended to provide a cost effective and rapid means of identifying individuals with a high viral load that means they are more likely to infect others.
  • The clinical data for Avactas AffiDX SARS-CoV-2 antigen lateral flow test reported 20 April 2021, demonstrated 100% sensitivity for identifying infectious individuals with viral loads measured by PCR of Ct
  • The product registration by a Competent Authority in the EU allows the Company to sell the product in the EU for professional use.
  • Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented: We are delighted to receive confirmation of the registration of the AffiDX SARS-CoV-2 antigen test in the EU.

MHRA Confirms Registration of Avacta’s AffiDX® SARS-CoV-2 Antigen Lateral Flow Test

Monday, June 7, 2021 - 8:51am

Avacta Group plc (AIM: AVCT), the developer of diagnostics and innovative cancer therapies based on its proprietary Affimer and pre|CISION platforms, is pleased to announce that the MHRA has confirmed registration of Avactas AffiDX SARS-CoV-2 antigen lateral flow test allowing the Company to place the product on the market in the UK for professional use.

Key Points: 
  • Avacta Group plc (AIM: AVCT), the developer of diagnostics and innovative cancer therapies based on its proprietary Affimer and pre|CISION platforms, is pleased to announce that the MHRA has confirmed registration of Avactas AffiDX SARS-CoV-2 antigen lateral flow test allowing the Company to place the product on the market in the UK for professional use.
  • Lateral flow antigen tests are intended to provide a cost effective and rapid means of identifying individuals with a high viral load that means they are more likely to infect others.
  • The clinical data for Avactas AffiDX SARS-CoV-2 antigen lateral flow test reported in April demonstrated 100% sensitivity for identifying infectious individuals with viral loads measured by PCR of Ct
  • Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented: I am delighted to receive confirmation of the registration of the AffiDX SARS-CoV-2 antigen test from the MHRA.

Avacta Receives Clinical Validation of AffiDX SARS-CoV-2 Antigen Lateral Flow Test

Tuesday, April 20, 2021 - 10:48am

b'Avacta Group plc (AIM: AVCT), the developer of diagnostics and innovative cancer therapies based on its proprietary Affimer\xc2\xae and pre|CISION\xe2\x84\xa2 platforms, is pleased to announce positive data from the clinical validation of its AffiDX\xc2\xae SARS-CoV-2 antigen lateral flow test.

Key Points: 
  • b'Avacta Group plc (AIM: AVCT), the developer of diagnostics and innovative cancer therapies based on its proprietary Affimer\xc2\xae and pre|CISION\xe2\x84\xa2 platforms, is pleased to announce positive data from the clinical validation of its AffiDX\xc2\xae SARS-CoV-2 antigen lateral flow test.
  • These data will now be combined with stability and other performance data from ongoing studies to finalise the technical file for CE marking the AffiDX SARS-CoV-2 antigen lateral flow test for professional use, allowing the Company to begin commercial roll-out in Europe in May.\nThe clinical evaluation of Avacta\xe2\x80\x99s lateral flow test was carried out at a single site in Europe with patient samples with viral loads confirmed by PCR.
  • Avacta\xe2\x80\x99s rapid antigen test identified 96/98 of these correctly as positive with a 20 minutes read time resulting in a clinical sensitivity of 98.0% for samples within this broad range down to low viral loads.
  • The clinical data for Avacta\xe2\x80\x99s AffiDX\xc2\xae SARS-CoV-2 antigen lateral flow test demonstrated 100% sensitivity for identifying infectious individuals in this range.\nDr Alastair Smith, Chief Executive of Avacta Group commented: \xe2\x80\x9cI am delighted with the clinical data from this larger clinical study, which has robustly evaluated the AffiDX antigen test with lower viral loads of Ct>26 as well as with higher viral load samples.

Avacta Announces Distribution Agreement With ABCAM plc

Tuesday, April 6, 2021 - 11:21am

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 it has entered into a global distribution agreement with ABCAM plc (AIM: ABC; NASDAQ: ABCM) to sell the Groups recently developed SARS-CoV-2 research ELISA Affimer reagents.

Key Points: 
  • 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 it has entered into a global distribution agreement with ABCAM plc (AIM: ABC; NASDAQ: ABCM) to sell the Groups recently developed SARS-CoV-2 research ELISA Affimer reagents.
  • ABCAM is one of the worlds leading suppliers of high-quality biological reagents and kits which are used in a wide range of fields including drug discovery, diagnostics and basic research.
  • Under the worldwide, non-exclusive distribution agreement, ABCAM will enable the global research community to access Avactas SARS-CoV-2 spike protein Affimer research reagents through its on-line catalogue.
  • Dr Alastair Smith, Chief Executive of Avacta Group commented: We are delighted that we have established a global route to market for the SARS-CoV-2 spike protein Affimer reagents through ABCAMs dedicated global commercialisation infrastructure.

Avacta’s Rapid Antigen Test Is Confirmed to Detect SARS-CoV-2 New Variants

Monday, March 8, 2021 - 7:30am

Some of these variants are more infectious, and therefore more rapidly transmissible, and have the potential to become dominant strains.

Key Points: 
  • Some of these variants are more infectious, and therefore more rapidly transmissible, and have the potential to become dominant strains.
  • Avacta has carried out analytical tests with the spike proteins isolated from both the B117 and D614G variants, and has confirmed that its AffiDX SARS-CoV-2 rapid antigen lateral flow test detects both of these variants as well as the original strain.
  • We will continue to monitor the performance of the Affimer reagents with future dominant variants as they become available to us.
  • Disclaimer: AffiDX SARS-CoV-2 Lateral Flow Rapid Antigen Test not currently for sale in the United States.

Avacta Announces Phase 1 Clinical Trial Authorisation (CTA) for AVA6000 Approved by MHRA

Thursday, February 18, 2021 - 8:05am

Alastair Smith, Chief Executive Officer of Avacta Group, commented: I am delighted to receive this approval for the AVA6000 Pro-doxorubicin phase I study from the MHRA.

Key Points: 
  • Alastair Smith, Chief Executive Officer of Avacta Group, commented: I am delighted to receive this approval for the AVA6000 Pro-doxorubicin phase I study from the MHRA.
  • This is a significant milestone for Avacta and opens the path to a potentially transformational clinical proof-of-concept study for AVA6000 and the pre|CISION platform.
  • My team are excited to be part of the AVA6000 Phase I first into human study and we look forward to enrolling patients into the clinical trial.
  • Neil Bell, Chief Development Officer of Avacta Group, commented: The AVA6000 clincial trial authorisation approval represents another important milestone for the pre|CISION platform and AVA6000 programme.

Avacta and Mologic Announce Commercial Partnership

Monday, February 8, 2021 - 8:59am

Avacta Group plc (AIM: AVCT) (Avacta), the developer of Affimer biotherapeutics and reagents, and Mologic Ltd (Mologic) today announced that they have entered into a commercial partnership to accelerate to market Avactas AffiDX SARS-CoV-2 lateral flow rapid antigen test.

Key Points: 
  • Avacta Group plc (AIM: AVCT) (Avacta), the developer of Affimer biotherapeutics and reagents, and Mologic Ltd (Mologic) today announced that they have entered into a commercial partnership to accelerate to market Avactas AffiDX SARS-CoV-2 lateral flow rapid antigen test.
  • Avacta will also support antigen testing in low and middle income countries1 by providing access to Avactas spike antigen test through Mologic.
  • The partnership between Avacta and Mologic also provides a framework agreement for the future development of a pipeline of tests in a range of disease areas.
  • Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented:
    I am very pleased to announce this partnership with Mologic, which follows a close collaboration over recent months.