Avacta Group plc, the developer of Affimer biotherapeutics and reagents, has started shipping Affimer reagents for COVID-19 antigen testing to its diagnostic test development partners.
The Group recently reported that it had generated multiple, highly specific Affimer reagents that bind the SARS-COV-2 viral antigen and do not cross-react with SARS, MERS and other closely related coronaviruses. These Affimer reagents will be used to develop a point-of-care saliva based COVID-19 antigen test strip by Cytiva (formerly GE Healthcare Life Sciences) for CE marking in Europe and FDA approval in the United States.
The Affimer reagents have been manufactured by Avacta in the quantities required for test development and are being sent to Cytiva. The reagents are also being provided to Adeptrix with whom Avacta has announced that it will develop a COVID-19 laboratory test to run on hospital mass spectrometers using Adeptrix’s proprietary BAMS assay platform.
The Affimer reagents have been studied further by Avacta and this has shown that there are Affimer reagents that can work in pairs, both binding to the spike protein at the same time. This allows tests to be developed that detect both the intact virus particle and the detached spike proteins which become separated from the virus particle during the development of the COVID-19 disease, which may also be important in monitoring disease progression.
Cytiva and Avacta will now work to develop rapid test strips for the detached spike protein and for the intact virus particle. Adeptrix is working to develop a prototype BAMS test. Both of these tests will indicate whether a person has the infection at that moment.

A research consortium led by the Jenner Institute, Oxford University is set to begin fast-tracked clinical trials for a COVID-19 vaccine.
The adenoviral vaccine candidate, ChAdOx1 nCov-19 (ChAdOx1) is one of five frontrunner vaccines in development around the world, and expected to be the UK’s first COVID-19 vaccine.
Developed at the Jenner Institute, ChAdOx1 is one of the most promising vaccine technologies for COVID-19 as it can generate a strong immune response from one dose.
Cobra Biologics (Cobra), an international CDMO for biologics and pharmaceuticals, issued a statement 31 March saying they had joined the consortium to assist with the rapid development scale-up and production of the vaccine.
The ChAdOx1 consortium includes the University of Oxford Jenner Institute, University of Oxford Clinical Biomanufacturing Facility, the Vaccines Manufacturing and Innovation Centre (VMIC), Advent Srl, Pall Life Sciences, Cobra Biologics and Halix BV.
The consortium is currently recruiting individuals from a range of ages in the UK to trial the vaccine’s efficacy, in April 2020 – a crucial step in the vaccine’s development. Cobra is actively planning for a fast set-up phase to facilitate the efficient production of a GMP working cell bank and then 200L GMP viral vaccine. The consortium partners expect to develop and manufacture the vaccine candidate in multiple batches, to support a 1 million dose scale batch size, by mid 2020.
For more information about the trial, visit: www.covid19vaccinetrial.co.uk

OXGENE and The Native Antigen Company have joined forces to scale up production of SARS-CoV-2 (COVID-19) reagents by combining OXGENE’s proprietary Adenoviral Protein Machine Technology with The Native Antigen Company’s antigen development expertise. Together, OXGENE and The Native Antigen Company will aim to scale their antigen manufacturing capabilities to deliver high-purity, recombinant proteins for the development of diagnostics and vaccines.
Together they are developing an improved, scalable approach to SARS-CoV-2 antigen manufacture. The Native Antigen Company was one of the first recognised suppliers of SARS-CoV-2 antigens in February 2020, demonstrating their ability to rapidly support the diagnostic and vaccine industries with high-quality infectious disease reagents. OXGENE’s Protein Machine Technology allows for the scalable production of viral proteins in mammalian cells using their proprietary adenoviral expression vector. Through genetic modification, the adenovirus is ‘tricked’ into making SARS-CoV-2 proteins rather than its own, thereby harnessing the innate power of highly scalable viral protein production.
The Native Antigen Company’s recombinant SARS-CoV-2 antigens are produced in mammalian cells to ensure full glycosylation and proper protein folding, both of which are essential for full biological and antigenic activity. The rapid scale up production of SARS-CoV-2 antigens is critical for the development of widely available diagnostic tests.
Unlike the PCR tests that are currently being used, these diagnostics will be able to confirm past infections and determine levels of immunity to SARS-CoV-2. This could be invaluable for disease modelling and public health policy, as true transmission rates and case fatality rates can be determined. These tests could also be instrumental for the diagnosis of healthcare workers who have been exposed to the virus to ensure that they have developed natural immunity before returning to work, and to help measure patient immune responses for the rapid development of a SARS-CoV-2 vaccine.
Dr Ryan Cawood, Chief Executive, OXGENE, said: “Our novel Protein Machine Technology represents a significant development in the rapid and scalable generation of high-quality viral proteins. We’re delighted that by collaborating with The Native Antigen Company, we can take advantage of our technology to support the needs of researchers racing to develop much-needed diagnostics and vaccines against COVID-19.”
This collaboration builds on a long-standing collegiate relationship between the two Oxford-based businesses as they work towards developing more scalable technologies for the diagnosis of disease, and the cost-effective manufacture of high-quality diagnostics and vaccines.
OXGENE and The Native Antigen Company aim to complete the first validation of this new paradigm in protein expression within the next month, which could have a demonstrable impact on the race to develop diagnostic kits and vaccines against this virus.
For further information about The Native Antigen Company’s Coronavirus Antigens, please visit: https://thenativeantigencompany.com/coronavirus-dashboard/

UK-based iPSC (induced pluripotent stem cells) disease modelling company DefiniGEN has identified iPSC-derived intestinal organoids that could be used to help structure in vitro studies of the biology of SARS-CoV-2 infection across cohorts of multiple patients.
While SARS-CoV-2 primarily targets the respiratory system, studies have shown that it also infects and multiplies within the intestinal epithelium. IPSC-derived organoids exhibit characteristics that closely mimic the in vivo intestinal epithelium, making them a valuable surrogate model for studying the virus.
The company says their iPSC-derived intestinal organoids provide a unique in vitro system to model the human intestine. The organoids display a polarized epithelium and harbour a mixture of cell types normally present in the primary intestinal epithelium barrier in vivo, including goblet cells, Paneth cells, enterocytes, LRG5+ stem cells, and enteroendocrine cells. The organoids polarise, form crypt structures and grow villi at the apical surface, and are shown to secrete mucus in a similar manner to primary human gut tissue.
DefiniGEN points out that several studies have proven that angio-tensin-converting enzyme 2 (ACE2) expression in host cells is required for SARS-CoV-2 recognition and infection. Activity of membrane proteases such as TMPRSS2 cleaves the coronavirus’ Spike protein and facilitates the membrane fusion with the host cell. Human intestine is one of the few human tissues with high expression of both ACE2 and TMPRSS2 therefore is a good candidate to study Covid-19 and the mechanisms of the SARS-CoV-2 infection.
Additionally, DefiniGEN have a platform to generate various patient-derived intestinal models which could support population studies, using many different donors with diverse ethnic profiles.
Such studies are useful as there is growing evidence that ethnic differences are a major factor in patients showing a severe response to Covid-19.
DefiniGEN’s differentiation platform is optimized to enable successful generation of intestinal organoids from a diverse range of patients. Patient skin fibroblasts or PBMCs can first be reprogrammed to iPSC, and then differentiated to produce mature intestinal organoids which carry the original patient genetics, and so manifest a gut model specific to that donor.
For more information, visit www.definigen.com/products/intestinal/covid-19

UK-based Avacta Group, the developer of Affimer biotherapeutics and reagents, will collaborate with US-based Adeptrix to develop a high throughput Covid -19 antigen test using Adeptrix’s proprietary bead-assisted mass spectrometry (BAMS) platform.
The Affimer-based BAMS coronavirus antigen test that will provide clinicians with a significant expansion of the available testing capacity for Covid-19 infection in hospitals.
Adeptrix’s novel BAMS platform combines enrichment of the sample to improve sensitivity with the power of mass-spectrometry to improve specificity. Hundreds of samples per day can be analysed by a single technician using BAMS, exceeding the capacity of single PCR machine, making BAMS a very attractive high throughput technique for Covid-19 screening in the clinical setting.
The diagnostic test will allow hospitals around the world to utilise their existing installed base of mass spectrometers that are not currently used for Covid-19 testing, thus contributing significantly to the increase in global testing capacity. Avacta’s recently developed Affimer reagents that bind the SARS-COV-2 spike protein will be used to provide the capture and enrichment of the virus particle from the sample which could be saliva, nasopharyngeal swabs or serum.
The companies are aiming to have a BAMS test ready for clinical validation, regulatory approval and manufacturing in June. Adeptrix and Avacta are already in discussion with large-scale manufacturing partners to rapidly deploy this new high throughput test.
Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented: “We believe that the BAMS test will be hugely attractive as an adjunct to PCR testing because it uses laboratory equipment that is already in hospital labs but not currently used for Covid-19 testing so it provides incremental testing capacity.
I have made it clear that we intend to partner the SARS-COV-2 spike protein Affimer reagents with several select companies to support antigen test development on multiple diagnostic test platforms. This will contribute most effectively to the urgent need to increase antigen testing capacity globally and maximise the commercial return to Avacta. Adeptrix is one example of this and other discussions are underway. I look forward very much to further updating the market in the near future.”
Dr. Jeffrey C. Silva, Director of Product Development, Adeptrix Corporation commented: “Mass spectrometry can enhance the diagnostic utility of immunoassays, as it is capable of monitoring both existing and emerging viral strains by accurately measuring the molecular components of the virus. BAMS provides an ideal multiplexing platform to obtain higher specificity for monitoring Covid-19 infection.”