• Up to 1,500 students and staff of Madrid’s major universities to undergo testing for COVID-19 as physical lessons restart

  • Pilot has the backing of Madrid’s Vice President Ignacio Aguado, who was in attendance at the launch

Medusa 19, the developer of the Rapid Saliva Protein Test (RSPT), has launched a landmark trial with Madrid’s public universities, as the city’s major education centres restart face to face lessons.

The pilot has been endorsed by Madrid’s Vice President Ignacio Aguado, who attended the launch of the trials at Universidad Autonoma de Madrid. Once completed, the Vice President has announced his intention to roll out the Medusa 19 RSPT for mass testing widely across the city, including on public transport links.

The pilot will see up to 1,500 students and staff members tested over a period of three weeks. As part of the trial, the Medusa 19 test, which could indicate current or previous infection through antibodies created in saliva, will be compared with results from blood antibody, PCR and antigen tests.

The pilot aims to prove that restrictions currently being placed on students can be reduced and that a return to full time education can be safely enabled by implementing a robust system of mass testing.

A successful pilot in Madrid would also give hope to UK students, who have struggled with infection rates in recent weeks. Oxford University reported that the number of weekly COVID-19 cases had more than tripled in the week to 16 October, while nearly 1,000 students at Durham University tested positive for COVID-19 last week.

The Medusa 19 RSPT, launched in September 2020, is a non-invasive test for IgM and IgG antibodies in a salivasample. Results are provided on the spot in 10 minutes, removing the need for laboratory testing. As these antibodies are identified earlier in saliva than blood, the RSPT can indicate an immune response to current or recent infection and can be taken in any location under medical supervision.

In clinical trials, undertaken in Madrid earlier this year, the test demonstrated 96 per cent sensitivity, relative specificity of 92 per cent and 94 per cent accuracy in patients with the absence of specific symptoms and who did not know they had an active SARS-CoV-2 infection.

The Manchester-based firm aims to use its test to rebuild confidence in the global economy, with a system of mass testing ensuring that workplaces and schools and universities can remain open for business. The firm currently hastwo million tests in stock, with capacity to scale manufacturing to 50 million units a month in the next six to eight weeks.

Christian Stephenson, chief development officer at Medusa 19, said: “This pilot is a huge first step to ensurethat students across the world can safely return to full time education, as well as highlighting the benefits that saliva-based tests can also offer to businesses. With its speed of results, the Medusa 19 RSPT could indicate immune response at a much earlier stage than blood antibody tests, ensuring that individuals can quickly follow government guidelines and contain the virus.

“With the capacity to scale up to 50 million units a month, the RSPT test can also play a crucial role as a triage test supporting the UK and Spanish Governments to remove the bottleneck in PCR testing capacity. It also provides a result in minutes without the normal 24/48 hour delay with PCR results. A mass testing regime would enable businesses and universities to accurately filter those that require a PCR test with those that do not.”

Ignacio Aguado, Vice President of Madrid, said: “This test could be a turning point in the detection of COVID-19. It may be the first self-diagnosis test that can be used at home and that would be revolutionary. I truly hope this pilot test is successful. If greenlighted, which I hope it will be soon, it will bolster the catalogue of tests available to public administrations.”

BREAKTHROUGH SALIVA-BASED LATERAL FLOW COVID-19 TEST LAUNCHED WITH A RESULT IN TEN MINUTES

The Rapid Saliva Protein Test (“RSPT”), from Medusa 19, provides results on the spot in 10 minutes. It is a lateral flow saliva test to indicate the immune response to infection particularly in patients who do not know they have an active SARS-CoV-2 infection and have no specific symptoms.

The 10-minute result window for a saliva immune response is a significant breakthrough for the COVID-19 testing market. The RSPT is point-of-care, providing rapid results on the spot.

The non-invasive test requires simple saliva collection, and is less intrusive than a blood sample, nasal or throat swab. Developed in the UK and Spain, the test indicates a user’s immune response to SARS-CoV-2, the virus underlying COVID-19.

Users provide a saliva sample into a collection tube, mixing this with a solution, which isolates and solubilises the protein structure present in saliva. This mixture is applied to a lateral flow device which migrates the saliva sample along the device. The test identifies antibodies unique to COVID-19, capturing them on test and control lines.

The RSPT isolates the protein complexes in saliva, allowing for recognition of saliva antibodies produced after the first contact with the virus, immunoglobulin M (IgM) and immunoglobulin G (IgG).  Antibodies are produced when a virus is present as part of the body’s immune system response to infection.

At the early stage of infection, human cells produce an immune response and generate IgG, but more specifically IgM at the point of contact with the virus, which for COVID-19 is in the throat and respiratory tract.  The antibodies are then transported from the lymph nodes into blood and saliva. In the early stage, detection in blood is not sensitive enough due to a high dilution effect, whereas in saliva, the independent clinical data indicates it is detectable.

Importantly, since this test indicates an immune response to current or recent infection, it can therefore alert users if they should immediately self-isolate to stop the spread of the disease.  Independent clinical trials were conducted in collaboration with Hospital Carlos III/Institute Carlos III – Hospital La PAZ, Madrid, on 254 participants.  In a cohort of patients with no specific symptoms, the trial demonstrated relative sensitivity of 96 per cent (ability to detect true positives), relative specificity of 92 per cent (ability to detect true negatives) and 94 per cent accuracy in patients with the absence of specific symptoms and who did not know they had an active SARS-CoV-2 infection.

The test is CE marked to 98/79/EC, registered with the MHRA, and is for use under supervision from a medical professional throughout Europe.  It could prove pivotal in helping companies safely reopen workplaces and take action in line with government guidance.  The RSPT is under application with the FDA Emergency Use Authorisation for approval in the USA.

Medusa 19 is currently working to develop an app which will act as a digital passport to verify and validate RSPT results, the Saturn Pass.

Christian Stephenson, Chief Development Officer at Medusa 19, commented: “Testing for infection is pivotal to navigating the pandemic. The clinical evaluation showed the detection of an immune response to the virus could be detected in patients with no specific symptoms rapidly and accurately from a saliva sample which is a game-changer. By testing on a mass scale, outbreaks can be quickly pin-pointed and brought under control, therefore avoiding the imposition of strict blanket lockdowns.

“The ability to rapidly test on a mass scale represents a huge leap forward for the global recovery from COVID-19, pioneered here in the UK. Clinical trial results are encouraging, and this could provide the global workforce with an accessible, reliable test, that can indicate an immune response to current or recent infection, even in carriers with no specific symptoms. It could be a lifeline for businesses struggling to safely reopen, and we are working tirelessly to seek approval for use for the general public too.”

Andy White, Managing Director of Medusa 19, added: “Development of the RSPT focused on providing end users with a highly accurate result quickly via a simple and non-invasive sampling process utilising saliva, with a test that had the potential to be manufactured globally and distributed worldwide. The Medusa 19 team has worked with extraordinary dedication to produce this unique test in a matter of months, alongside the necessary infrastructure and fulfilment capability and we are delighted with the clinical results.

“Global demand for a reliable and rapid test of this nature is expected to be in the billions of tests per annum, and therefore it is important that we are able to manufacture and distribute this test widely, both at home and overseas. The infrastructure behind the test means it can be produced on mass, and by investing in a wide roll-out of this unique test, businesses can take a vital step forward in getting back to work safely, in line with government guidance.”

 

Medusa 19 is also exploring a number of other complementary tests and diagnostic products, and earlier this year entered an exclusive distribution agreement with Avacta Group plc for direct-to-consumer sales of a saliva-based antigen test. It will utilise its infrastructure to distribute this product worldwide once available.

Avacta and Liverpool School of Tropical Medicine collaborate to clinically validate saliva-based rapid coronavirus test being developed with Cytiva

Avacta Group plc (AIM: AVCT), the developer of Affimer® biotherapeutics and reagents, is pleased to announce that it has entered into a collaboration with the Liverpool School of Tropical Medicine (“LSTM”) to clinically validate the rapid, saliva-based coronavirus antigen test that Avacta is developing with Cytiva.

LSTM has been at the forefront of research into infectious, debilitating and disabling diseases since 1898 and was the first institution in the world dedicated to research and teaching in tropical medicine. It has a research portfolio of around £320 million and projects and partnerships in more than 70 countries.

Under the terms of the collaboration, LSTM will carry out the clinical validation of the Avacta COVID-19 antigen rapid saliva test in their category 3 laboratories on patient samples. In addition to working with the UK government’s CONDOR programme to provide Avacta with access to patient samples in the UK, the partnership with LSTM also provides the opportunity to access patient samples in Africa and South America. The higher prevalence of the disease in those regions means that samples for prospective clinical validation studies are more readily available which, if necessary, could be used to speed up the validation process.

Clinical validation is the process of evaluating the performance of a diagnostic test using real patient samples. Clinical validation generates the sensitivity and specificity performance parameters which are most often used to define the performance of a diagnostic test.

LSTM is currently evaluating the performance of prototype lateral flow tests provided by Cytiva alongside Avacta’s ELISA laboratory test using SARS-CoV-2 coronavirus samples, as a precursor to full clinical validation studies.

Dr. Alastair Smith, Chief Executive of Avacta Group commented:

“I am delighted to have established this collaboration with the Liverpool School of Tropical Medicine. It is an important partnership which provides Avacta with access to patient samples both in the UK and abroad, where the incidence of the disease is currently much higher, to ensure prompt access to a sufficient number of samples for clinical validation.

We have been working with the Liverpool School of Tropical Medicine for some time to define the target performance specifications of the saliva-based rapid test and their insight has been tremendously helpful in this regard.

I look forward to updating the market on further progress in due course.”

Dr Lisa Baldwin, Business Development Manager, LSTM commented:

“The partnership between Avacta and LSTM exemplifies the role of the LSTM in translational work to advance products to market and we are pleased to be working with Avacta on this coronavirus antigen test.”

Avacta appoints BBI Solutions as manufacturing partner for the rapid SARS-CoV-2 antigen test being developed with Cytiva

Avacta Group plc (AIM: AVCT), the developer of Affimer® biotherapeutics and reagents, is pleased to announce that it has appointed BBI Solutions, part of BBI Group (“BBI”), to manufacture the saliva-based rapid SARS-CoV-2 antigen test that is being developed with Cytiva.

BBI Solutions is a leading global developer and manufacturer of raw materials and finished test products for the in-vitro diagnostics market, with manufacturing sites in five different countries, spanning four continents.

The manufacturing agreement between Avacta and BBI comprises the accelerated development and validation of a scaled-up manufacturing process that has the potential to ramp up to a production capacity of millions of tests per month. Avacta, Cytiva and BBI are in the process of the technology transfer of the prototype and related manufacturing procedures for the saliva-based rapid SARS-CoV-2 antigen test from Cytiva to BBI.

Avacta aims to begin clinical validation of the test as soon as possible by using the first pilot batches generated as part of the technology transfer process for these studies. In parallel with these clinical validation studies, which will be run within the UK government’s CONDOR programme and potentially with other collaborators globally, BBI will work with Avacta and Cytiva to produce the additional technical documentation that is required for CE marking of the final product.

Dr. Alastair Smith, Chief Executive of Avacta Group commented:

“I am delighted to be working with BBI to manufacture the rapid COVID-19 test. BBI has been excellent to work with to define a highly compressed product development timeline that will allow us to get the product to market as quickly as possible.

We anticipate very high demand for the COVID-19 rapid test and will be working with our preferred manufacturing partners at BBI to satisfy that demand. We are actively continuing our discussions with other manufacturing partners to ensure that we have access to additional manufacturing capacity to address the global need for SARS-CoV-2 antigen testing both now, and in the next few years.

As we set out in the use of proceeds at the recent fund raising, we have now expanded our product development team with the appointment of an experienced in-vitro diagnostic Product Development Manager, and we are expanding the protein production facilities in order to meet the expected demand for Affimer proteins for the COVID-19 tests and future diagnostic tests in the pipeline.

The diagnostics business has also been working at a rapid pace towards ISO13485 accreditation, which will streamline CE marking and other regulatory approval processes.

I am immensely proud of what has been achieved by Avacta’s diagnostics team. Their progress in just a few months would have been challenging under normal circumstances, but with the additional restrictions imposed by COVID-19, it has been an outstanding example of hard work, ingenuity and commitment from a world-class team.

I look forward to further updating the market as we go through the next stages of manufacturing scale-up, clinical validation, regulatory approval and product launch.”

Dr. Mario Gualano, Chief Executive of BBI Group:

“BBI are delighted to have been appointed to lead the manufacture of Avacta’s rapid coronavirus antigen test, and to be able to further extend our lateral flow expertise to addressing the global challenges presented by COVID-19.

Our ability to respond rapidly to Avacta’s needs is testament to our team’s diagnostic expertise and the supporting manufacturing and quality systems we have implemented at our ISO13485 accredited facility.”

This announcement contains information which, prior to its disclosure, was considered inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (MAR).

Positive initial data from first Affimer-based rapid test strips for SARS-COV-2 spike protein

Avacta Group plc (AIM: AVCT), the developer of Affimer® biotherapeutics and reagents is pleased to announce that the first Affimer-based rapid test strips to detect SARS-COV-2 spike protein have been developed and evaluated by Avacta’s partners at Cytiva (formerly GE Healthcare Life Sciences) and show positive initial performance data.

In mid-May Avacta provided Affimer reagents that are specific to the SARS-COV-2 spike protein to Cytiva which has now developed the first lateral flow test strips using these reagents and generated initial performance data using coronavirus spike protein.

These data show that the test strips detect the spike protein in model samples at concentrations within the clinical range found in saliva of patients with COVID-19. Work continues now to refine the test strip design, optimise its performance and get the best detection limit possible in order to generate the highest sensitivity in the final rapid test product.

Following the optimisation of the lateral flow test by Cytiva the design will then be transferred to manufacturing partners in the UK that are currently being put in place by Avacta. The Company is working with these manufacturers to compress the normal manufacturing, clinical validation and regulatory timelines in order to bring a product to market as quickly as possible.

Dr. Alastair Smith, Chief Executive of Avacta Group commented:

“I am delighted with the progress made by our partners at Cytiva and very encouraged by the positive data from the first test devices. We now need to optimise the test performance to achieve the best possible limit of detection as this will ultimately play a significant factor in determining the clinical sensitivity of the test.

This is a really positive step and we aim to have completed the optimisation very soon so that we can begin the transfer to manufacturers. I will be updating the market on progress in due course.”

Klaus Hochleitner, Global Lead, Technology Product Specialist at Cytiva, commented:

“I am pleased that the test development has progressed from a working initial design to now focussing on optimising the test as much as possible. The Affimer reagents have worked well in lateral flow test strips and we are very encouraged by the initial data.”

This announcement contains information which, prior to its disclosure, was considered inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (MAR).