On May 14, 2020 Vyriad announced that it had completed the development of a serology test to measure protective immunity against SARS-CoV-2, the novel coronavirus that causes COVID-19. The Vyriad IMMUNO-COVﾙ antibody test detects neutralizing antibodies, the critical subset of antibodies known to protect against SARS-CoV-2 viral infections. Vyriad and Regeneron jointly developed the test as part of their existing discovery and development collaboration. The test was expected to be available through major CLIA-certified testing labs by the end of May.

The disease-causing SARS-CoV-2 virus uses its spike protein to infect healthy cells and spread throughout the body. The IMMUNO-COV™ antibody test uses an innocuous virus that has been engineered to carry this SARS-CoV-2 spike glycoprotein on its surface. It analyzes human blood serum to detect only the antibodies capable of ‘blocking’ the action of this spike glycoprotein, thus preventing the SARS-CoV-2 virus from infecting new cells. This is distinct from most existing serology tests which do not confirm the virus-neutralizing function of antibodies they detect.

Since the start of the COVID-19 outbreak in December 2019, experts believe millions of people around the world may have contracted the disease, many with asymptomatic infections or mild infections that go undetected or undiagnosed. People who recover from COVID-19 infection may develop an antibody response to the pathogen, which creates immunological memory and potentially protects them from future exposure to the virus. These antibodies are typically detectable in the blood approximately 14 days after the onset of infection.

Vyriad had internally validated this assay and was conducting ongoing assay verification studies to continually evaluate assay performance. The assay validation results and methodology had been submitted to the FDA in accordance with regulatory requirements for COVID-19 Emergency Use Authorization. The test was run at Vyriad’s CLIA-approved laboratory in Rochester, Minnesota. Vyriad does not engage in patient services and can only accept testing requests from a referring physician or laboratory.  It was anticipated that this test would be commercially available through major laboratories within the next few weeks.

Since October 2019, Vyriad has been working exclusively with Regeneron to research and develop vesicular stomatitis virus (VSV)-based oncolytic virus technologies. This collaboration now includes the IMMUNO-COV™ antibody test, which was developed utilizing the deep scientific expertise of both companies. Regeneron’s proprietary VelociSuite® technologies and Vyriad’s virus engineering capabilities enabled development of this scalable assay in a rapid timeframe.