Clinical validation of AffiDX Lateral Flow Test
20 April 2021
Avacta Group plc
("Avacta" or "the Group" or "the Company")
Clinical validation of AffiDX ® SARS-CoV-2 Antigen Lateral Flow Test
98.0% clinical sensitivity for samples with PCR Ct values [1] up to 31
Completing the technical data set for self-declaration of a CE mark for professional use in early May, followed immediately by commercial launch in Europe
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 positive data from the clinical validation of its AffiDX® SARS-CoV-2 antigen lateral flow test. Data from the clinical study conducted in Europe on 98 positive COVID-19 samples demonstrate excellent performance in identifying the SARS-CoV-2 virus across a broad range of viral loads. 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.
The clinical evaluation of Avacta's lateral flow test was carried out at a single site in Europe with patient samples with viral loads confirmed by PCR. The study tested 98 positive samples (31 with Ct<26; 65 with Ct 26-30 and 2 with Ct 30-31). Avacta's 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. Out of a total of 102 negative samples tested with the lateral flow device, the test correctly identified 101 as negative, giving a clinical specificity of 99.0%.
Lateral flow rapid antigen tests are intended to provide a low cost means of identifying individuals with a high viral load that means they are more likely to infect others. Many factors affect whether an individual will infect others or not, as well as viral load, such as the circumstances and length of exposure. However, there is a growing consensus that a viral load as measured by PCR of Ct<27 should be considered as infectious. The clinical data for Avacta's AffiDX® SARS-CoV-2 antigen lateral flow test demonstrated 100% sensitivity for identifying infectious individuals in this range.
Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented:
"I 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. The results are very impressive and marks a major step in obtaining a CE mark for professional use.
"As part of the 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 value and in particular at lower viral loads.
"We are completing the necessary assessment of the product from our manufacturing partner Global Access Diagnostics, including stability testing that will complete the technical file for CE marking, which we expect will happen in early May.
"We are very excited by the potential of this high quality SARS-CoV-2 rapid antigen test and we are looking forward to updating the market as we commercially roll-out the AffiDX® test in the coming months. "
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).
Disclaimer: The AffiDX® SARS-Cov-2 rapid antigen test is not currently available for sale in the United States.
- Ends
For further information from Avacta Group plc, please contact:
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Avacta Group plc |
Tel: +44 (0) 844 414 0452 |
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Alastair Smith, Chief Executive Officer |
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Tony Gardiner, Chief Financial Officer |
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finnCap Ltd (Nominated Adviser and Joint Broker) |
Tel: +44 (0) 207 220 0500 |
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Geoff Nash / Giles Rolls - Corporate Finance Tim Redfern - ECM |
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Stifel Nicolaus Europe Limited (Joint Broker) |
Tel: +44 (0) 207 710 7600 |
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Nicholas Moore / Nick Adams / Fred Walsh / Ben Maddison |
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FTI Consulting (Financial Media and IR) |
Tel: +44 (0) 203 727 1000 |
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Simon Conway / Stephanie Cuthbert |
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Zyme Communications (Trade and Regional Media) |
Tel: +44 (0) 7787 502 947 |
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Katie Odgaard |
About Avacta Group plc - https://www.avacta.com
Avacta Group is developing powerful diagnostics and novel cancer immunotherapies 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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[1] Ct or cycle time indicates the number of cycles of amplification required before the virus gene can be detected by PCR. The higher the Ct value the more amplification that was needed to identify the virus in the sample, and therefore the lower the amount of virus present. Conversely, a high viral load means that there is more virus present and fewer amplification cycles are required to detect it mean a lower Ct value is returned.
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