Avacta Group receives UK approval for AffiDX® COVID-19 test
Avacta, which develops cancer therapies and diagnostics based on its proprietary Affimer® and pre|CISION™ platforms, submitted a declaration of conformity for CE mark for its AffiDX® SARS-CoV-2 antigen rapid test through its partner Mologic in early May 2021.
Following a delay in the MHRA submission, Avacta said last week that it expected to receive confirmation of registration of the AffiDX® test for the UK market from the MHRA shortly.
Avacvta developed the lateral flow test using its Affimer® platform to detect the coronavirus spike antigen. In April 2021, it released positive data from the clinical validation of the AffiDX® 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.
Avacta confirmed to investors this morning that it has now received a confirmation of registration from MHRA meaning it can sell the product in the UK for professional use. Avacta said it expects product registration from a Competent Authority within the EU to follow shortly.
It said ongoing commercial discussions are underway with distributors as well as with end user customers in countries that accept the CE mark for in vitro diagnostic products.
Addressing shareholders, Dr Alastair Smith, Chief Executive of Avacta Group said, “I am delighted to receive confirmation of the registration of the AffiDX® SARS-CoV-2 antigen test from the MHRA. It is a transformative milestone for Avacta's Diagnostics Division being the first CE marked product powered by the Affimer® platform that has been brought to market.”
"We are very excited by the potential of this high-quality SARS-CoV-2 rapid antigen test and by the interest it has already attracted from potential commercial partners and distributors. We will continue to focus on its commercial roll-out and manufacturing scale-up to meet demand.
"Lateral flow tests have a crucial role to play in helping our society and economy return to normal, and I am confident that the AffiDX® test will now play a significant part in this process,” he added.
View from Vox
Following the confirmation of this registration, Avacta will now be able to commercially roll-out its AffiDX® test across Europe this month by immediately placing the test on 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 since the beginning of 2021. The stock was trading 5.23% higher this morning at 251.5p immediately following the announcement.
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 in recent months 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 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.
Follow News & Updates from Avacta Group here:
Disclaimer & Declaration of Interest
The information, investment views and recommendations in this article are provided for general information purposes only. Nothing in this article should be construed as a solicitation to buy or sell any financial product relating to any companies under discussion or to engage in or refrain from doing so or engaging in any other transaction. Any opinions or comments are made to the best of the knowledge and belief of the writer but no responsibility is accepted for actions based on such opinions or comments. Vox Markets may receive payment from companies mentioned for enhanced profiling or publication presence. The writer may or may not hold investments in the companies under discussion.