Roche has expanded its Cyclospora testing portfolio in collaboration with its subsidiary TIB MOLBIOL, introducing two new research-use PCR testing solutions to support laboratories responding to the continuing outbreak across the United States. The new assays are designed to provide laboratories with flexible and cost-effective molecular testing options for detecting Cyclospora cayetanensis and other gastrointestinal parasites.
Cyclospora cayetanensis is a food and waterborne parasite that can cause severe gastrointestinal illness, including prolonged diarrhea, fatigue and abdominal cramping. As outbreaks continue to place pressure on healthcare systems and public health laboratories, rapid research testing has become increasingly important for understanding disease transmission and supporting outbreak investigations.
The latest additions include the LightMix Modular Cyclospora assay and the LightMix OneTube Gastro Para 2 assay. Both are intended for research use only and are compatible with Roche LightCycler 480 and LightCycler PRO instruments. The Modular Cyclospora assay enables specific detection of Cyclospora using hydrolysis probe chemistry, while the OneTube Gastro Para 2 assay offers multiplex real-time PCR detection of six gastrointestinal parasites, including Entamoeba histolytica, Giardia, Dientamoeba fragilis, Cryptosporidium, Blastocystis and Cyclospora cayetanensis.
These assays complement Roche’s existing UC-TIB-Gastro-PARA-2 research panel, which is designed for high-throughput testing on cobas 5800, 6800 and 8800 systems through the cobas omni utility channel. Together, the portfolio offers laboratories multiple testing formats depending on the number of targets and platform requirements.
Dan Malarek, President and CEO of Roche Diagnostics North America, said the company remains committed to helping laboratories respond quickly to emerging public health challenges through strong scientific partnerships and reliable molecular testing infrastructure. Marcus Droege, CEO of TIB MOLBIOL, added that the expanded portfolio gives laboratories the flexibility to choose between single-target and multiplex testing solutions while maintaining cost efficiency across different research environments.
Roche continues to strengthen its infectious disease testing capabilities across a wide range of public health threats, including respiratory illnesses, vector-borne diseases, sexually transmitted infections and emerging pathogens. The company recently developed a research-use molecular PCR assay for the Ebola Bundibugyo virus within days to support response efforts in Africa, demonstrating its ability to rapidly develop testing solutions for evolving infectious disease situations.
The new LightMix Modular Cyclospora assay, LightMix OneTube Gastro Para 2 assay and UC-TIB-Gastro-PARA-2 assay are strictly intended for Research Use Only and are not approved for diagnostic procedures. Roche stated that the expanded portfolio reflects its continued focus on supporting laboratories with advanced molecular tools that help strengthen infectious disease research and public health preparedness.
Roche is a global healthcare company founded in Basel, Switzerland, in 1896. The company combines pharmaceuticals, diagnostics and digital healthcare technologies to develop solutions for patients across more than 150 countries. Roche focuses on therapeutic areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology, while continuing to invest in scientific innovation and advanced diagnostic technologies.
