Avacta Group (AIM: AVCT ) has released positive data from the clinical validation of its AffiDX® SARS-CoV-2 antigen lateral flow test which demonstrated 98% clinical sensitivity.
The Group, which develops diagnostics and innovative cancer therapies, said the data from the 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 a 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.
The data will be combined with stability and other performance data from ongoing studies to finalise the technical file for CE marking the AffiDX® SARS-CoV-2 antigen lateral flow test for professional use, allowing the Company to begin commercial roll-out in Europe in May.
In particular, 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.
‘Many factors affect whether an individual will infect others or not, as well as viral load, such as the circumstances and length of exposure. However, there is a growing consensus that a viral load as measured by PCR of Ct<27 should be considered as infectious,’ it noted.
The Company added that clinical data for its AffiDX® SARS-CoV-2 antigen lateral flow test has demonstrated 100% sensitivity for identifying infectious individuals in this range.
"I am delighted with the clinical data from this larger clinical study, which has robustly evaluated the AffiDX® antigen test with lower viral loads of Ct>26 as well as with higher viral load samples. The results are very impressive and mark a major step in obtaining a CE mark for professional use,” commented Dr Alastair Smith, Chief Executive of Avacta Group.
He added, "We are completing the necessary assessment of the product from our manufacturing partner Global Access Diagnostics, including stability testing that will complete the technical file for CE marking, which we expect will happen in early May.
We are very excited by the potential of this high-quality SARS-CoV-2 rapid antigen test and we are looking forward to updating the market as we commercially roll-out the AffiDX® test in the coming months."
Today’s news marks a further validation for the company whose next milestone will be to achieve full clinical validation and CE marking for its AffiDX® rapid antigen lateral flow test.
The data will now be combined with stability and other performance data from ongoing studies to allow the Group to begin the commercial roll-out of the test across Europe in May.
Shares in Avacta Group have more than doubled in value since the beginning of 2021. The stock was trading 18.38% higher this morning at 277p 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 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 it 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.