A Letter From our CEO Chris Macek on Cepheid's New Rapid Sars-CoV-2 Test and SystemOne's COVID-19 Module for Aspect

Tuesday, March 24, 2020

Dear Customers and Stakeholders,

Cepheid announced on Saturday that it has been awarded an Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for the Xpert® Xpress SARS-CoV-2, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19. The test will operate on any of Cepheid's more than 23,000 automated GeneXpert® machines worldwide, with a detection time of approximately 45 minutes. The FDA’s EUA means that implementation in the U.S. can begin immediately.

Cepheid is working with global regulatory bodies to clear the test for implementation on its devices in other countries. SystemOne currently supports over 3,000 GeneXpert devices in 32 countries, and has the capacity to expand to many more devices and countries to help fight COVID-19 and other infectious diseases. SystemOne is ready with a new COVID-19 support module for GeneXpert to accurately and securely report test results once approvals and cartridges are available. Ministries of Health planning to integrate COVID-19 testing with at-risk TB and HIV populations can contact SystemOne now for more information about the functionality and features of our COVID-19 module for Aspect.

We join the world’s infectious disease experts in highlighting the fact that the poor and the marginalized, especially those with pre-existing co-infections such as TB and HIV, will be disproportionately affected by the COVID-19 pandemic. Rapid, accurate and connected diagnostic data is greatly needed to contain the SARS-CoV-2 virus. We’re a major step closer today to that goal.

Sincerely,

Chris Macek and the SystemOne Team

Learn more about the COVID-19 module for Aspect