Roche Expands Cyclospora Testing Portfolio to Support U.S. Public Health Response

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On Aug. 6, 2026, Roche announced the availability of two new flexible and cost-effective research PCR testing options for labs to address the public health impact of the Cyclospora cayetanensis parasite.

Roche is committed to advancing global health security by equipping healthcare systems with the tools they need to better detect and manage infectious diseases and other emerging threats to public health. Its comprehensive suite of tests helps identify and manage some of the world’s most challenging infectious diseases, from hepatitis and HIV, other sexually transmitted infections (STIs), and respiratory illnesses like influenza and tuberculosis, to diseases spread by insects such as dengue and malaria, and infections passed from mother to baby, like rubella. Last month. Roche developed a RUO molecular PCR test within six days to detect the rare Ebola Bundibugyo virus and to support response efforts in Central and East Africa.

The two new tests are used with the LightCycler® 480 and LightCycler® PRO instruments. The LightMix® Modular Cyclospora assay (for research use only, or RUO) is for the specific detection of cyclospora only using hydrolysis probe chemistry. The LightMix® OneTube Gastro Para 2 assay (RUO) includes multiplex, real-time PCR detection of Entamoeba histolytica, Giardia, Dientamoeba fragilis, Cryptosporidium, Blastocystis and Cyclospora cayetanensis. These complement an existing assay, UC-TIB-Gastro-PARA-2 (RUO), a multiplex, real-time PCR test for high-throughput research, detecting Dientamoeba fragilis, Blastocystis hominis and Cyclospora cayetanensis in a single reaction. It is used with the cobas® 5800, 6800 and 8800 systems.

TIB MOLBIOL develops pre-designed assays and multiple target panels for research use only with LightCycler® instruments and with the cobas®omni utility channel on cobas® 5800, 6800 and 8800 systems. The cobas® omni utility channel is a dedicated open channel on Roche’s cobas® 5800, cobas® 6800 and cobas® 8800 systems that enables a broader testing menu by consolidating research testing with Roche IVD assays on a single platform. After more than 20 years of collaboration, Roche acquired TIB MOLBIOL in December 2021 to expand its PCR-test portfolio in the fight against new infectious diseases. Roche and TIB MOLBIOL continue to build on their capabilities for the rapid development of assays for emerging pathogens and potential health threats, such as infectious diseases.

The LightMix® Modular Cyclospora assay, the LightMix® OneTube Gastro Para 2 assay and the UC- TIB-Gastro-PARA-2 assay are for Research Use Only. Not for use in diagnostic procedures.

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