Roche Expands Cyclospora PCR Testing Portfolio to Support Ongoing US Outbreak Response

As public health officials continue to investigate one of the largest documented Cyclospora cayetanensis outbreaks in the US, Roche has expanded its molecular testing portfolio with 2 new real-time polymerase chain reaction (PCR) assays, providing laboratories with additional options for detecting the foodborne parasite.

The announcement comes as thousands of cyclospora infections have been reported across multiple states, underscoring the growing need for rapid laboratory identification and surveillance. Although the new assays are designated for research use only (RUO) and are not intended for diagnostic use, they provide laboratories with additional tools to study the parasite and support outbreak investigations.

Cyclospora is a microscopic parasite transmitted through contaminated food or water that can cause prolonged gastrointestinal illness. Symptoms often include severe watery diarrhea, abdominal cramping, fatigue, nausea, loss of appetite, and weight loss. While illness is typically self-limited in healthy individuals, severe dehydration and prolonged disease can lead to hospitalization, particularly among older adults and immunocompromised patients.

"Understanding disease outbreaks and how they spread can have a huge impact on public health," said Dan Malarek, president and CEO of Roche Diagnostics North America. "Our robust testing infrastructure and strong scientific partnerships enable us to provide solutions that help labs rapidly respond to evolving public health needs."

Expanding Laboratory Options

The expanded portfolio includes the LightMix Modular Cyclospora assay, which specifically detects Cyclospora cayetanensis, and the LightMix OneTube Gastro Para 2 assay, a multiplex PCR panel that detects 6 gastrointestinal parasites, including Cyclospora, Giardia, Cryptosporidium, Entamoeba histolytica, Blastocystis, and Dientamoeba fragilis.

The assays are designed for Roche's LightCycler 480 and LightCycler PRO platforms and complement the company's existing UC-TIB-Gastro-PARA-2 assay, which operates on the cobas 5800, 6800, and 8800 systems for high-throughput research applications.

According to Marcus Droege, CEO of TIB MOLBIOL, the expanded portfolio provides laboratories with flexibility in choosing testing strategies.

"The cyclospora portfolio provides the option of panel size and platform type and the economics of 1, 3, or 6 targets, offering flexible and cost-effective tests," Droege said.

Implications for Infection Prevention

Although the assays are not approved for routine clinical diagnosis, infection preventionists may recognize their potential value during outbreak investigations and epidemiologic research.

Rapid molecular detection can help researchers better understand transmission patterns, identify contaminated food sources, and evaluate how outbreaks spread across geographic regions. During large multistate outbreaks, timely laboratory data also support collaboration between clinical laboratories, public health agencies, and food safety investigators.

For infection prevention and public health professionals, the announcement also reflects a broader trend toward expanding molecular surveillance capabilities for emerging infectious diseases.

Roche noted that its infectious disease portfolio already includes testing for HIV, hepatitis viruses, sexually transmitted infections, influenza, tuberculosis, dengue, malaria, and congenital infections. The company also highlighted its recent development of a research-use PCR assay for the Ebola Bundibugyo virus, which can be run within 6 days to support response efforts in Central and East Africa.

As foodborne outbreaks continue to challenge public health systems, flexible molecular testing platforms may become increasingly important for understanding pathogen transmission and supporting coordinated outbreak response.

While the new cyclospora assays remain research tools rather than diagnostic tests, they represent another example of how molecular technologies continue to evolve alongside modern infectious disease surveillance.