The company plans to invest in its Diagnostics site in Indianapolis in a project that runs through 2030. It expects to make the site — which serves as the North American headquarters for Roche Diagnostics — a major hub for manufacturing its CGM systems.
Roche said its Indianapolis campus houses key operations, including U.S. R&D, labs, manufacturing, distribution, IT and administrative functions. It currently produces approximately 5.2 billion Accu-Chek diabetes test strips annually.
The company expects the expansion to generate hundreds of highly skilled manufacturing jobs and thousands of construction jobs. It could also enhance domestic production capabilities and reduce dependency on imports. This not only strengthens local manufacturing but may address tariffs put into place by the Trump Administration.
“The challenges of diabetes are pervasive, with millions of Americans living with the constant vigilance and countless daily decisions the disease requires. By expanding our manufacturing capabilities in Indianapolis, we ensure reliable access to innovative monitoring solutions for individuals living with diabetes in the U.S. and worldwide,” said Brad Moore, president and CEO at Roche Diagnostics North America.
More about the CGM offerings delivered by Roche
Roche’s CGM technology pipeline includes the Accu-Chek SmartGuide system. The company first unveiled its Accu-Chek SmartGuide in an event at the 2024 Advanced Technologies & Treatments for Diabetes (ATTD) conference. It won CE mark for the CGM in July 2024. At this time, the latest-generation system doesn’t hold FDA approval.
Accu-Chek SmartGuide features a 14-day wear time, a one-step application process and watertight properties. The system also utilizes predictive AI to provide glucose predictions showing estimated developments for different timeframes. Based on the CGM data, the system’s app shows where glucose levels might go in the next two hours. Every five minutes, the CGM sensor sends glucose values measured in real time to an application.
The predictive app then utilizes those values and other available information to detect patterns and predict future glucose levels. Integrated AI helps to indicate hypoglycemia risk within the next 30 minutes. It also helps to forecast low glucose levels and estimate the risk of nocturnal hypoglycemia.
Clinical evaluations of the Roche CGM delivered a mean absolute relative difference (MARD) — a measure of CGM accuracy — of 9.2%. Roche reports that 99.8% of measured glucose values fall within zones A and B on the Parkes Error Grid. The CGM’s predictive capabilities also exceeded performance requirements such as accuracy, sensitivity, specificity and events detected.
