Testing for COVID-19

CAMBRIDGE, U.K. & BEVERLY, Mass.—Avacta recently announced a collaboration with Adeptrix through which the companies will work to develop a high-throughput COVID-19 antigen test using Adeptrix’s proprietary bead-assisted mass spectrometry (BAMS) platform, reportedly providing clinicians with a significant expansion of the available testing capacity for COVID-19 infection in hospitals using samples from saliva, nasopharyngeal swabs or serum.

“We are delighted to have established this partnership with Adeptrix in our push to develop Affimer -based COVID-19 antigen tests,” said Dr. Alastair Smith, CEO of Avacta Group. “Jeff [Dr. Jeffrey C. Silva] and his team are world-renowned in the mass spectrometry field, and the BAMS diagnostic platform is highly sensitive and specific, giving us great confidence that a high-performance COVID-19 antigen test can be developed and launched commercially very quickly.”

Avacta’s Affimer technology offers an alternative to antibodies across a range of applications, including diagnostics. The company has worked with a variety of partners to develop high-performance diagnostics, and had previously demonstrated that the Affimer platform could be used to quickly generate new and highly specific reagents to detect the Zika virus, showing its utility in response to an epidemic/pandemic. Additionally, Avacta was able to identify and characterize the reproducible Affimer reagents that bind to the SARS-CoV-2 spike protein within just four weeks. These reagents do not cross-react with other very closely related viruses, such as SARS and MERS, which is important when approaching COVID-19.

“I am pleased to have Avacta recognize the promise of the BAMS technology with respect to its sensitivity, accuracy and high-throughput capacity,” said Silva, who is director of product development at Adeptrix. “I have worked with Affimers previously and have found them to be excellent immunoassay reagents, so we are looking forward to quickly implementing the SARS-CoV-2 Affimers in a BAMS diagnostic test.”

Avacta’s researchers realized the importance of a triple-pronged approach to diagnostic development to cover all three market areas: point-of-care (POC), consumer-based and lab-based tests. By applying the Affimer binders across platforms in all three sectors, the company believes it will contribute most effectively to the urgent need to increase antigen testing capacity globally.

Although antibodies have shown to be effective reagents in immunodiagnostics, they have well-documented limitations, prolonging the timeline of test development and evaluation and restricting the ability of diagnostics companies to respond to outbreaks fast enough. Affimer reagents can be developed in weeks vs. months for antibodies, using cost-effective and standardized processes that only require sub-milligram quantities of antigen.

Avacta has established two test development partnerships to date, including the one with Adeptrix. Adeptrix’ BAMS platform is reportedly able to 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.

Governments are globally scaling up diagnostic development programs to urgently provide COVID-19 testing. The Affimer-based BAMS test supports this critical need by offering significant expansion of lab-based testing capacity.

“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,” Smith stated. “A consensus view is building around the world that hundreds of millions of COVID-19 tests are going to be required per month for a long period, and that the disease will be endemic after the initial pandemic has passed, meaning that testing for COVID-19 is going to be needed for many years.”

“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,” he continued. “This will contribute most effectively to the urgent need to increase antigen testing capacity globally and maximize 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.”

On June 9, Avacta announced that the test had reached prototype stage and can detect the SARS-CoV-2 spike protein in model samples in the concentration range appropriate for a clinical diagnostic test.

The next step in the development of the final product that will run on the installed base of mass spectrometers in clinical laboratories around the world is to evaluate and optimize the BAMS assay using patient samples at laboratory sites in the United Kingdom and United States.

Alongside the partnership with Adeptrix, the Affimer SARS-CoV-2 binders will also be implemented through a collaboration with Cytiva into a lateral flow assay, to develop both professional point-of-care tests and consumer self-tests.