AffiDX Lateral Flow Test Detects Delta Variant

29 June 2021

Avacta Group plc

("Avacta" or "the Group" or "the Company")

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

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.

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 Avacta's AffiDX® SARS-CoV-2 antigen lateral flow test demonstrated 100% sensitivity for identifying infectious individuals with viral loads measured by PCR of Ct<27, which is considered infectious.¹

The SARS-CoV-2 virus, like most viruses, mutates over time to create different variants and those that have a biological advantage will become a dominant strain. The Delta variant, first identified in India, has recently emerged, has greater infectivity, and may rapidly become a dominant strain world-wide.

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<29, the test was shown to correctly identify all the positive cases. In this study, two other commercially available lateral flow tests were evaluated: One test detected half the positive cases and the other detected none.

The AffiDX® SARS-CoV-2 antigen lateral flow test is CE marked for professional use in the UK and EU. The Company has recently appointed the first distributor for the test, Calibre Scientific, and is progressing multiple commercial opportunities with other distributors and professional end users in Europe and the UK.

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. This is a variant of the virus that is spreading rapidly on a global scale and therefore the ability of the test to detect this variant is paramount to our commercial roll-out.

"In comparison with other lateral flow tests on the market, Avacta's rapid antigen test demonstrates better clinical performance. This is a further huge validation of the Affimer® reagent platform for use in in-vitro diagnostics.

"This excellent performance and ease of nasal sampling, coupled with the fact that the AffiDX® test has been developed in the UK, is based on UK technology and is manufactured in the UK are huge selling points for customers in Europe."

Disclaimer: The AffiDX® SARS-Cov-2 rapid antigen test is not currently available for sale in the United States.

^[1] Liverpool COVID-19 community testing pilot: interim evaluation report 

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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 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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