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The importance of the Global Supply Chain for COVID-19 Diagnostics

April 22, 2020

In vitro diagnostic testing is often a behind-the-scenes activity in health care. Most of us are unaware of what is required to get a test result once we have provided a fluid or tissue sample. High-volume testing is a technologically complex undertaking that depends upon a global supply chain to not only provide the tests but also develop the instruments and other consumables required to process the results.

The example of Roche Diagnostics’ cobas® SARS-CoV-2 Test may help to illustrate the complexity involved. The test received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on March 12, 2020. Developed in about six weeks in response to the COVID-19 crisis—high-volume diagnostic tests normally take 18 months or more to reach regulatory review—the Roche test now is in use throughout the U.S. Hundreds of thousands of American patients have already been tested for the novel coronavirus using the Roche test, and its key components and requirements come from all over the world, illustrating the global interdependencies with creating a sophisticated test of this kind. Consider just some of the pieces involved: 

  • Manufacturing of the Roche test kits takes place in the U.S. (New Jersey).
  • The kits include highly specialized liquids called reagents, necessary for the identification of SARS-CoV-2. These reagents come from production facilities in Germany and other locations across the world. Because these reagents require sensitive manufacturing processes, it would take months for new companies in other locations to replicate the manufacturing processes involved and to begin producing these reagents on a large scale.
  • The Roche cobas® SARS-CoV-2 test was developed to run on the cobas® 6800 or 8800 systems, which are fully automated instruments—requiring little-to-no time consuming human intervention. The cobas® 8800 system includes approximately 23,000 components sourced all over the world, with 101 sub-assemblies and a total assembly time of approximately 450 hours each. Final production of these instruments takes place in Switzerland, in factories that would take months or years to replicate and equip.
  • Obtaining samples from patients requires specific types of sample collection swabs as well as Personal Protective Equipment (PPE) for the safety of health-care professionals.  

 

A global supply chain—one that never stops moving—integrates these components where and when they are needed. Together, and only together, these components enable a high volume of tests for COVID-19 in dozens of countries experiencing the pandemic.

The highly interdependent supply chain for our machines, reagents and consumables is not unique to Roche­–every other manufacturer of novel coronavirus tests could share similar descriptions. No single company or country can lay claim to essential components of testing that originate around the world. We must work together as a global society to ensure the broadest possible availability of tests and test supplies in order to win the battle against coronavirus.