Roche expands cyclospora testing portfolio to support U.S. public health response

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Roche (OTCQX: RHHBY) announced the launch of two new real-time PCR tests for research detection of Cyclospora cayetanensis, developed with subsidiary TIB MOLBIOL, to support U.S. public health efforts amid an ongoing cyclospora outbreak.

The LightMix® Modular Cyclospora assay (RUO) targets cyclospora only on LightCycler® 480 and LightCycler® PRO instruments, while the LightMix® OneTube Gastro Para 2 assay (RUO) enables multiplex detection of six gastrointestinal parasites, including Cyclospora. These tests complement the existing UC-TIB-Gastro-PARA-2 multiplex RUO assay for cobas® 5800/6800/8800 systems. All assays are for research use only and not for diagnostic procedures.

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• Roche has launched two new, real-time PCR tests to detect cyclospora, a diarrhea-causing infection, to help meet diverse needs of laboratories.
• The new tests expand the Roche cyclospora portfolio, providing laboratories with more flexible choices.
• Cyclospora tests are another example of Roche's leadership in infectious disease testing and long-standing commitment to improving public health.

INDIANAPOLIS, Aug. 6, 2026 /PRNewswire/ -- As a cyclospora outbreak continues to spread throughout the United States,^1,2 Roche (SIX: RO, ROG; OTCQX: RHHBY), in collaboration with subsidiary TIB MOLBIOL, announces 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.

Food and waterborne parasite Cyclospora cayetanensis can cause serious gastrointestinal illness such as severe diarrhea, fatigue and cramping,¹ and can place pressure on local emergency rooms. ¹

"Understanding disease outbreaks and how they spread can have a huge impact on public health," said Dan Malarek, President and CEO, 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."

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.

"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.

About the TIB MOLBIOL portfolio

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.

About Roche 
Roche is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions. Roche was founded in Basel, Switzerland, in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.

Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

Research Use Only. Not for diagnostic use.  

References

1. Centers for Disease Control and Prevention. Cyclospora Outbreak Linked to Iceberg Lettuce in 9 States. Accessed July 24, 2026.
2. U.S. Food and Drug Administration. Investigation of 9-State Outbreak of Cyclospora Illnesses: Iceberg Lettuce. Accessed July 24, 2026.
3. Cleveland Clinic. Cyclosporiasis: Transmission, Symptoms & Treatment. Accessed July 28, 2026.
4. The Today Show. "ER Doctors in 'Diarrhea Parasite' Cyclospora Hotspot Describe Top Symptoms: 'This Isn't Subtle.'"  Accessed July 23, 2026.

For Further Information 

Roche Diagnostics U.S. Media Relations
us.mediarelations@roche.com

Krystina Monaco

1-317-850-7521

krystina.monaco@roche.com 

Lori McLaughlin

1-463-207-2395

lori.mclaughlin@roche.com 

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SOURCE ROCHE DIAGNOSTICS CORPORATION

FAQ

What did Roche (RHHBY) announce about new cyclospora PCR tests on August 6, 2026?

Roche announced two new real-time PCR assays for research detection of Cyclospora cayetanensis. According to Roche, these RUO LightMix® assays expand its cyclospora portfolio to support laboratories responding to the ongoing U.S. cyclospora outbreak and broader gastrointestinal parasite research.

Which instruments support Roche’s new cyclospora research tests mentioned for RHHBY investors?

The new LightMix® Modular Cyclospora and LightMix® OneTube Gastro Para 2 assays run on LightCycler® 480 and LightCycler® PRO instruments. According to Roche, they complement the UC-TIB-Gastro-PARA-2 RUO assay used with cobas® 5800, 6800 and 8800 systems.

Are Roche’s new cyclospora PCR assays for RHHBY intended for diagnostic use?

Roche’s new cyclospora PCR assays are for Research Use Only and not for diagnostic procedures. According to Roche, the LightMix® Modular Cyclospora, LightMix® OneTube Gastro Para 2 and UC-TIB-Gastro-PARA-2 tests support research on gastrointestinal parasites, including Cyclospora cayetanensis.

How do Roche and TIB MOLBIOL collaborate on cyclospora testing solutions for RHHBY?

Roche and its subsidiary TIB MOLBIOL co-developed the new cyclospora research assays. According to Roche, TIB MOLBIOL designs pre-configured assays and multipanel tests for LightCycler® instruments and cobas® omni utility channels, enabling rapid development for emerging infectious disease threats.

What parasites are covered by Roche’s LightMix OneTube Gastro Para 2 assay related to RHHBY?

The LightMix® OneTube Gastro Para 2 assay detects Entamoeba histolytica, Giardia, Dientamoeba fragilis, Cryptosporidium, Blastocystis and Cyclospora cayetanensis. According to Roche, it offers multiplex, real-time PCR capability for gastrointestinal parasite research on LightCycler® instruments as a flexible RUO panel option.

How does Roche’s expanded cyclospora portfolio support the U.S. outbreak response?

Roche’s expanded cyclospora portfolio gives laboratories multiple RUO PCR options for Cyclospora cayetanensis detection. According to Roche, these flexible and cost-effective assays help labs study the outbreak’s spread and characteristics, supporting broader public health and emergency room pressure mitigation efforts.