Avacta Group submits registration for CE mark for its AffiDX® rapid antigen test
(AVCT ) told investors that it has submitted a declaration of conformity for CE mark for its AffiDX® SARS-CoV-2 antigen rapid test for professional use to the Medicines and Healthcare products Regulatory Agency ("MHRA") through the Group's partner Mologic.
Avacta, which develops cancer therapies and diagnostics based on its proprietary Affimer® and pre|CISION™ platforms, informed shareholders that it expects to receive confirmation of this registration of the AffiDX® in-vitro diagnostic device ‘in the coming days.’
Avacvta developed the lateral flow test using its Affimer® platform to detect the coronavirus spike antigen. Last month, it released positive data from the clinical validation of the AffiDX® SARS-CoV-2 antigen lateral flow test which demonstrated 98% overall clinical sensitivity.
Data from a study in Europe on 98 positive COVID-19 samples demonstrated an ‘excellent performance’ in identifying the SARS-CoV-2 virus across a broad range of viral loads.
The clinical evaluation of Avacta's lateral flow test, which tested 98 positive samples, was carried out at a single site in Europe with patient samples with viral loads confirmed by PCR.
The test identified 96/98 of these correctly as positive with 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%, the company told investors.
At the time, Avacta said the data would be combined with other performance data from ongoing studies to finalise the technical file for CE marking the AffiDX® SARS-CoV-2 test for professional use, allowing the Company to begin commercial roll-out in Europe in May 2021.
The Company confirmed to investors this morning that this data has now been combined and that 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.
Following the confirmation of the registration of the AffiDX® in-vitro diagnostic device which is expected in the coming days, Avacta will be able to place the test on the market.
"I am absolutely delighted to have reached this significant milestone for the Diagnostics Division and Avacta Group,” said Dr Alastair Smith, Chief Executive of 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,” he added.
View from Vox
Today’s news sees Avacta edge closer towards its milestone of achieving full clinical validation and CE marking for the AffiDX® test which is now expected in the coming days.
Following the confirmation of this registration, Avacta will be able to commercially roll-out the test across Europe this month by immediately placing the test of the market.
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.
Shares in Avacta Group have more than doubled in value since the beginning of 2021. The stock was trading 2.19% higher this morning at 267.73p following the announcement.
Reasons to AVCT
Avacta is developing cancer immunotherapies and diagnostics based on its two proprietary platforms - Affimer® biologics and pre|CISION™ tumour targeted chemotherapies.
Its 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, which is a market that is believed to be worth in excess of $100bn.
Therapeutics
The 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.
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 Company is building a wholly owned pipeline of novel cancer therapies designed to be effective for all cancer patients.
In 2021, Avacta commenced a phase 1 first-in-human, open label, dose-escalation and expansion study of AVA6000 Pro-doxorubicin, the Company's lead pre|CISIONTM prodrug, in patients with locally advanced or metastatic selected solid tumours.
COVID-19 Test Development
Avacta has also developed a SARS-CoV-2 lateral flow rapid antigen test aimed at identifying infectious individuals so that they can isolate promptly and reduce the spread of COVID-19.
Recent data returned earlier this week from the Company’s ongoing clinical studies across Europe and the UK demonstrated an ‘excellent performance’ of the SARS-CoV-2 rapid antigen test in identifying patients with an infectious viral load and no false positive results.
As a result of ‘excellent initial data’, the Company said it will now progress to a full clinical validation with a larger number of patient samples to CE mark the test for professional use, aiming to bring the test to market in Europe around the end of the first quarter of this year.
These data from the first clinical studies will allow it the Group to advance into a full clinical validation of the test, manufactured at scale, at its clinical trial sites in the UK and the EU.
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