New Imaging-Based Serology Test Platform for COVID-19 to Confirm Activity of SARS-CoV-2 Vaccines

Capricor Therapeutics, Inc. (Los Angeles, CA, USA) has received from Johns Hopkins University (Baltimore, MD, USA) a non-exclusive license to intellectual property, know-how and data related to a new imaging-based serology test platform for COVID-19. This platform, which is amenable to a vast array of serology applications, has been applied to the analysis of patient antibodies to multiple SARS-CoV-2 proteins, including spike, nucleocapsid, and membrane.

The study conducted by Johns Hopkins University researchers marks a new approach to serology testing that harnesses the unique ability to human cells to present viral proteins in their native context and native conformation, and thereby captures and quantifies the true spectrum of patient antibodies to pathogen-encoded proteins. In the study designed to interrogate the utility of an imaging-based serology testing platform, patient plasmas were interrogated for the presence of antibodies to the SARS-CoV-2 spike (S), nucleocapsid (N), membrane (M), and other virus-encoded proteins, using genetically engineered cells as solid-phase support for antigen display in their native conformations and environment. The initial focus on detecting antibodies to S, N, and M proteins reflects their importance for the viral replication cycle, their abundance in virus particles, and the inclusion of all multiple proteins in Capricor’s potential SARS-CoV-2 exosome/RNA vaccine and VLP vaccine products.

The technology demonstrates several key advantages of imaging-based serology, which includes in-sample negative controls and gating of signal strength by specificity of signal pattern, capture of antibodies to proteins in their native conformations and environment within human cells, and the potential for simultaneous interrogation of multiple target proteins.

“In the present example, know-how in the areas of basic cell biology and imaging was used to develop a new approach to antibody testing that can provide COVID-19 patients, SARS-CoV-2 vaccine recipients with valuable insights into the array of SARS-CoV-2 antibodies they possess,” said Dr. Linda Marbán, Ph.D., CEO of Capricor. “Furthermore, we plan to convert the current version of the serology test to a multiplexed imaging test for clinical applications within and beyond the scope of SARS-CoV-2, and we intend to explore the potential for partnership opportunities for our COVID-19 technology.”

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