Prognostic COVID-19 Severity Test Launched in United States

A prognostic COVID-19 Severity Test (CST; EpiSwitch CST, Oxford BioDynamics) has been launched in the United States for the identification of high-risk individuals who are likely to experience the most severe COVID-19 complications upon exposure to the virus.

Requiring only a routine blood draw, the test can help identify those who would require hospitalization and intensive care unit (ICU) support. Additionally, the test may be beneficial for managing care among patients who are immunocompromised or immunosuppressed, as well as for those who may not be able to get vaccinated for other medical reasons.

“As COVID-19 continues to have a major impact on us all, smarter, not just more, testing is required to enable us to make informed decisions and manage our lives and livelihoods,” said Jon Burrows, PhD, CEO of Oxford BioDynamics, in a press release.

Since the standard COVID-19 tests that are now available only detect current or prior infection, the CST provides the opportunity to predict immune response using 3D genomic biomarkers to assess immune health. Using these biomarkers, the CST can predict the probable severity of a patient’s potential response to SARS-CoV-2 before infection.

The CST may also be beneficial for individuals who are already known to have a high risk of severe or critical disease by allowing for increased infection mitigation, early aggressive medication upon infection, or other early interventions in the event of SARS-CoV-2 infection. By providing a score assessing the potential response severity, the CST can help physicians and at-risk patients establish a preemptive health care management plan to address effective clinical decisions, lifestyle choices, and workplace strategies.

The release of the CST is based on the findings of a recent, genome-wide study conducted among patients who had previously tested positive for COVID-19. The study identified key 3D genomic biomarkers to determine the severity of patient response to infection.

The test was then validated using international cohorts of 116 COVID-19 patients, which included patients from North America, South America, and the United Kingdom, with the full spectrum of severity response included. The results demonstrated that the CST could predict the need for a critical response requiring ICU support with 92% high accuracy, 96% sensitivity, 86% specificity, 92% positive predictive value, and 93% negative predictive value.

“Even with advanced national vaccination programs underway, millions of people (10 million in the US alone) remain exposed to the risk of severe COVID-19 disease because they are immunocompromised/immunosuppressed or for other medical reasons cannot be vaccinated,” Burrow said in the press release. “Understanding their individual risk will enable them and their physicians to formulate a proactive health care plan, and ensure they take appropriate infection mitigation measures.”

REFERENCE

Oxford BioDynamics announces US launch of its EpiSwitch® COVID-19 Severity Test (CST). Oxford, England: Oxford BioDynamics; March 23, 2021. https://www.businesswire.com/news/home/20210323005589/en. Accessed March 24, 2021.