[Source Avacta]
Avacta Group (AVCT ) said a study has shown that the company’s AffiX® antigen lateral flow test is able to detect the Delta variant of the SARS-CoV-2 virus with “very high sensitivity.”
The Group, which develops diagnostics and cancer therapies, said clinical data for its AffiDX® SARS-CoV-2 lateral flow test demonstrated 100% sensitivity for identifying infectious individuals with viral loads measured by PCR of Ct<27, which is considered infectious.
Ct refers to the number of cycles needed to amplify viral RNA to reach a detectable level. AffiDX® was evaluated with a small number of patient samples confirmed to be Delta variant positive and, for a Ct<29, the test was shown to correctly identify all the positive cases.
The Delta variant, which has recently emerged and was first identified in India, has proven to have greater infectivity in people, and may rapidly become a dominant strain world-wide.
Typical of most viruses, the SARS-CoV-2 virus will mutate over time to create different variants and those that have a biological advantage will become a dominant strain.
Commenting on the results, Dr Alastair Smith, Chief Executive Officer of Avacta Group said: “This is a variant of the virus that is spreading rapidly on a global scale and therefore the ability of the test to detect this variant is paramount to our commercial roll-out.”
In addition, Avacta’s AffiDX® test was also proven to outperform two lateral flow antigen tests currently commercially available in Europe. Following the evaluation, one of the tests only detected half the positive cases than AffiDX® while the other test detected none.
"In comparison with other lateral flow tests on the market, Avacta's rapid antigen test demonstrates better clinical performance,” said Smith, who added that this demonstration is “a further huge validation of the Affimer® reagent platform for use in in-vitro diagnostics.”
Avacta recently appointed Calibre Scientific as its first distributor for AffiDX®, which is already CE marked for professional use in the UK and EU. It now continues to progress commercial opportunities with other distributors and professional end users in Europe and the UK.
"This excellent performance and ease of nasal sampling, coupled with the fact that the AffiDX® test has been developed in the UK, is based on UK technology and is manufactured in the UK are huge selling points for customers in Europe,” Smith highlighted to investors.
View from Vox
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.
Last week, Avacta 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).
It signed a non-exclusive distribution agreement with Calibre Scientific, a provider with a global reach of over 100 countries across a wide array of verticals and geographies.
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 increased by nearly 70% in value since the beginning of 2021. The stock was trading 4.60% higher this morning at 182p 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 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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