[source: Avacta]

Avacta Group (AVCT ) has begun the shipment of its AffiDX® SARS-CoV-2 antigen lateral flow test, a ‘high performance’, 20-minute antigen test which uses patient-friendly nasal swabbing. 

To date, the AffiDX® SARS-CoV-2 test has been shown by independent clinical evaluation to be 100% sensitive for patient samples with a PCR Ct value below 27 (indicative of a high viral load), 98.0% sensitive across a much wider range of viral loads and with 99% specificity. 

The AffiDX® SARS-CoV-2 test is CE marked for professional use in the UK and EU and has been proven to detect the Delta variant of the SARS-CoV-2 virus with “very high sensitivity.”  

In June, 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.   

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.  

Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented: "I am delighted that shipment of the AffiDX® SARS-CoV-2 antigen lateral flow test has commenced.” 

Addreshing investors he said, “The excellent clinical performance and ease of nasal sampling, coupled with the fact that the AffiDX® antigen test has been developed in the UK, and is based on UK technology and manufactured in the UK, are major points of differentiation.” 

Avacta recently appointed Calibre Scientific, a global distributor of diagnostic and life science products, as the first distributor for the test in the UK and EU, and is progressing multiple commercial opportunities with distributors and end users in Europe, UK, Asia and elsewhere. 

The Company highlighted that its manufacturing scale up continues to “progress well” as it remains focused on the challenge of being able to supply the clear demand in the market. 

"We continue to see significant levels of commercial interest from around the world and are progressing a number of opportunities in a range of sectors,” added Dr Alistair Smith. 

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.    

In recent weeks, Avacta 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).   

In June 2021, Avacta noted that its AffiDX® test was 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.”  

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 20% in value since the beginning of the year. The stock was trading 0.27% lower this morning at 130.15p following the news. 

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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