Avacta Group (AVCT ) said it expects to receive a confirmation of registration of its AffiDX® test from the Medicines and Healthcare products Regulatory Agency ("MHRA") ‘shortly.’
The Group, which develops diagnostics and innovative cancer therapies, announced last month that its partner, Mologic, had officially submitted the Declaration of Conformity for CE mark for Avacta’s AffiDX® SARS-CoV-2 antigen rapid test for professional use in the UK.
At the time, the Group said it expected to receive confirmation of this registration ‘in the coming days’ however the submission was made eighteen days later on 28 May 2021 due to an error made by an independent regulatory consulting agency sub-contracted by Mologic.
Avacta continues discussions with distributors and customers for its test and said it does not anticipate that the error will cause a delay to first commercial sales of the product.
Following the delayed MHRA submission, it is now anticipated that Mologic will receive confirmation of registration of the AffiDX® test for the UK market from the MHRA shortly.
Avacvta developed its lateral flow test using its Affimer® platform to detect the coronavirus spike antigen. In April, 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.
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 has also confirmed that the submission of the Declaration of Conformity has also been made to a Competent Authority in an unnamed European Union member state to enable marketing and sale of the AffiDX® SARS-CoV-2 antigen lateral flow test in the EU.
Avacta also noted that the SARS-CoV-2 test referenced in a social media post on 27 May, highlighting an email that had been obtained from the MHRA reporting rejection of a filing of a Declaration of Conformity of an antigen test from Mologic, was an unrelated Mologic test, not the the company’s antigen lateral flow test as purported in the social media post.
Avacta said it will soon update the market on the responses from the Competent Authorities in the UK and EU and on commercial progress for its AffiDX® SARS-CoV-2 antigen lateral flow test.
View from Vox
Following the confirmation of the registration of the AffiDX® in-vitro diagnostic device which is expected to occur shortly, Avacta will be able to place the test on the market, enabling it to fulfil its milestone of achieving full clinical validation and CE marking for the AffiDX® test.
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.
‘Although more than a little frustrating, the 18 day delay in submitting Avacta's highly accurate, rapid lateral flow test for CE marking by a Mologic appointed 3rd party sub-contractor/agency, should be viewed as a small bump along a much more positive path.’
Shares in Avacta Group have more than doubled since the beginning of 2021. The stock was trading 1.68% lower this morning at 233.02p immediately following the statement.
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 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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