Roche announced on Thursday the launch of two new PCR tests designed to detect Cyclospora cayetanensis as cyclosporiasis cases in the United States climbed to record levels this year, making the foodborne-illness outbreak one of the largest in the country’s recent history.
The Swiss healthcare company is collaborating with its subsidiary, TIB MOLBIOL, to supply the tests. The new additions expand Roche’s cyclospora testing portfolio and are intended for research use only.
New Assays Expand Cyclospora Detection Capabilities
The two new real-time PCR tests detect pathogens by identifying their genetic material. The LightMix Modular Cyclospora assay is designed for the specific detection of Cyclospora cayetanensis using hydrolysis probe chemistry.
The second test, the LightMix OneTube Gastro Para 2 assay, is a multiplex real-time PCR assay that detects Entamoeba histolytica, Giardia, Dientamoeba fragilis, Cryptosporidium, Blastocystis and Cyclospora cayetanensis.
These assays complement Roche’s existing UC-TIB-Gastro-PARA-2 assay, a multiplex, real-time PCR test for high-throughput research that detects Dientamoeba fragilis, Blastocystis hominis and Cyclospora cayetanensis in a single reaction. The assay is used with the cobas 5800, 6800 and 8800 systems.
The newly launched tests are used with the LightCycler 480 and LightCycler PRO instruments.
Testing Portfolio Offers Multiple Screening Options
According to Roche and TIB MOLBIOL, the cyclospora testing portfolio gives laboratories a choice of screening for one, three or six parasites across different testing platforms.
“The cyclospora portfolio provides the option of panel size and platform type and the economics of one, three or six targets, offering flexible and cost-effective tests,” said Marcus Droege, CEO of TIB MOLBIOL.
TIB MOLBIOL develops pre-designed assays and multiple target panels for research use with LightCycler instruments and with the cobas omni utility channel on the cobas 5800, 6800 and 8800 systems. Roche acquired TIB MOLBIOL in December 2021 after more than 20 years of collaboration between the companies.
U.S. Health Authorities Continue Outbreak Investigation
Earlier this week, U.S. health authorities said they had widened their investigation into a cyclosporiasis outbreak tied to iceberg lettuce from central Mexico after identifying cases in six additional states. The expansion increased the number of affected states in the investigation to 15.
According to the U.S. Centers for Disease Control and Prevention and the Food and Drug Administration, about 6,358 cases and at least 278 hospitalizations have been reported from those 15 states. The agencies also noted that their surveillance data lags state reporting by several weeks.
Cases have continued to rise across the United States in recent months, according to the CDC, with reports from 47 states. Cyclospora cayetanensis is a food- and waterborne parasite that can cause gastrointestinal illness, including severe diarrhea, fatigue and cramping.
Roche stated that the LightMix Modular Cyclospora assay, the LightMix OneTube Gastro Para 2 assay and the UC-TIB-Gastro-PARA-2 assay are all designated for research use only and are not intended for use in diagnostic procedures.
Rising Demand for Molecular Diagnostics
The latest outbreak has highlighted the growing need for accurate molecular diagnostic technologies. Healthcare providers rely on laboratory testing to distinguish parasitic infections from other gastrointestinal conditions that can produce similar symptoms.
PCR-based methods can help laboratories identify specific genetic material from pathogens. This approach can provide clinicians with valuable information when evaluating patients with persistent digestive symptoms.
Challenges in Outbreak Detection
Foodborne disease outbreaks can be difficult to track because infections may occur across different locations and over an extended period. Identifying common sources often requires cooperation between healthcare providers, laboratories, food-safety authorities and public-health agencies.
Increasing infection rates can place additional pressure on diagnostic laboratories. Facilities may need to process more samples while maintaining accurate and consistent testing procedures.Early laboratory confirmation can support these investigations by helping officials identify patterns and determine whether reported illnesses may be connected.
