Roche rolls out new PCR tests as Cyclospora outbreaks hit U.S.

The rollout includes the LightMix Modular Cyclospora assay and the LightMix OneTube Gastro Para 2 assay, both designed for research use. These tools allow laboratories to run specific tests for the parasite or broader panels that identify additional gastrointestinal pathogens, including Cryptosporidium and Giardia. The tests are compatible with the LightCycler 480 and LightCycler PRO instruments, offering scalable solutions for varying laboratory demands.

Dan Malarek, President and CEO of Roche Diagnostics North America, emphasized that rapid identification of outbreaks is critical to managing public health. By expanding the testing portfolio, Roche seeks to alleviate pressure on emergency departments currently seeing an influx of patients suffering from symptoms like fatigue, cramping, and severe diarrhea. The company noted that these research-only tools complement existing high-throughput options already deployed on cobas 5800, 6800, and 8800 systems.

Marcus Droege, CEO of TIB MOLBIOL, stated that the new additions provide laboratories with the necessary economics and platform versatility to address emerging threats. Roche acquired TIB MOLBIOL in 2021 specifically to accelerate the development of molecular diagnostics for infectious diseases. While these new assays are restricted to research purposes and cannot be used for clinical diagnostics, they represent a broader push by the company to equip healthcare systems with rapid-response tools against evolving pathogens.