Avacta Group enters non-exclusive deal for AffiDX® in UK and EEA
(AVCT ) has entered a new agreement granting the professional use of its AffiDX® SARS-CoV-2 antigen lateral flow test in the UK and European Economic Area (EEA).
The Group, which develops diagnostics and cancer therapies based on its proprietary Affimer® and pre|CISION™ platforms, announced that it has entered into a non-exclusive distribution agreement with the global provider of life science products, Calibre Scientific.
Calibre Scientific, which is headquartered in Los Angeles, California, has a global reach extending to over 100 countries across a wide array of verticals and geographies.
As part of the distribution agreement, Avacta’s AffiDX® SARS-CoV-2 antigen lateral flow test will be listed on Calibre's web site and available to be purchased by professional users.
Dr Alastair Smith, CEO of Avacta Group, commented: "We are delighted that we have put in place this distribution agreement for the AffiDX SARS-CoV-2 antigen lateral flow test for professional use with Calibre. As a high quality, global distributor of diagnostics and life science products with excellent links to our target markets, we are confident Calibre is well placed to support our penetration of the professional end use market in the UK and EEA.”
Looking ahead, the company highlighted to investors that it will continue to focus on developing direct sales opportunities to major corporations and other large scale end users.
Addressing shareholders, the Company stated: "We are also in discussion with potential customers in territories outside the UK and EEA, including some of the APAC region, where the additional regulatory approvals required beyond CE marking are minimal.”
"Lateral flow tests have a crucial role to play in helping societies and the global economy return to normal and Avacta's AffiDX antigen test, developed in the UK and based on UK technology is well placed to play a significant role in this process,” the company noted.
Earlier this month, the Medicines and Healthcare products Regulatory Agency (“MHRA”) confirmed the registration of Avacta’s AffiDX® SARS-CoV-2 antigen lateral flow test, which allowed the company to place the test product on the market in the UK for professional use.
The Company 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.
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Following the recent confirmation of registration from the MHRA, Avacta has been able to commercially roll-out its AffiDX® test across Europe by 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 7.42% lower this morning at 197.94p 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.
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.
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