Infection Control Today® Editorial Staff

 oocysts under magnification, stained bright red. cyclosporiasis outbreak, foodborne parasites, intestinal infections. water pollution.

As public health officials continue to investigate one of the largest documented 

 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."

The expanded portfolio includes the LightMix Modular Cyclospora assay, which specifically detects 

, and the LightMix OneTube Gastro Para 2 assay, a multiplex PCR panel that detects 6 gastrointestinal parasites, including 

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.

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.

Articles

Roche has introduced 2 new research-use PCR assays for Cyclospora cayetanensis, expanding laboratory testing options as public health officials continue to respond to one of the largest Cyclospora outbreaks in US history.

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

Copacabana Beach and Ipanema Beach in Rio de Janeiro, Brazil

A once-weekly oral HIV treatment regimen could soon offer people living with HIV a new alternative to daily antiretroviral therapy, according to late-breaking phase 3 data presented at the 26th International AIDS Society Conference on HIV Science (AIDS 2026) in Rio de Janeiro, Brazil.

 announced positive results from the ISLEND-1 and ISLEND-2 phase 3 clinical trials evaluating an investigational once-weekly single-tablet regimen combining islatravir (ISL) 2 mg and lenacapavir (LEN) 300 mg in adults with virologically suppressed HIV-1. The regimen has the potential to become the first approved long-acting oral HIV treatment requiring just one dose per week.

Both studies demonstrated that participants who switched from daily oral antiretroviral therapy maintained virologic suppression through 48 weeks, at rates comparable to those of participants receiving standard daily regimens.

ISLEND-1 demonstrates noninferiority to BIKTARVY

 evaluated adults who switched from BIKTARVY (bictegravir/emtricitabine/tenofovir alafenamide) to once-weekly ISL/LEN.

At Week 48, investigators found the investigational regimen was statistically noninferior to continuing BIKTARVY. None (0%) of the participants who switched to ISL/LEN had HIV-1 RNA levels of 50 copies/mL or greater, compared with 0.3% of participants who remained on BIKTARVY, according to the US FDA's snapshot analysis.

Jürgen Rockstroh, MD, PhD, professor of medicine and head of the HIV Outpatient Clinic at University Hospital Bonn in Germany and primary investigator for ISLEND-1, emphasized both the clinical performance and the potential impact on patient choice.

"People living with HIV have shown strong interest in having more treatment options, including long-acting oral regimens. In the ISLEND-1 trial, switching to once-weekly oral ISL/LEN was well tolerated and maintained high rates of viral suppression. The effectiveness of the investigational combination regimen was comparable to B/F/TAF, and no treatment-emergent resistance to ISL/LEN has been seen so far. The Phase 3 results presented at AIDS 2026 and published in 

 provide strong evidence for the potential of ISL/LEN to be the first and only once-weekly oral HIV treatment option, expanding choice with a longer dosing interval that may better fit the different needs and preferences of people living with HIV."

ISLEND-2 supports switching from multiple daily regimens

 evaluated adults with virologically suppressed HIV who switched from a variety of standard daily oral antiretroviral therapies.

Results mirrored those seen in ISLEND-1. At Week 48, the once-weekly regimen met the primary end point of statistical noninferiority. Only 0.3% of participants receiving ISL/LEN had HIV-1 RNA levels of at least 50 copies/mL compared with 1.3% of participants who continued their baseline daily therapies.

Beyond maintaining viral suppression, investigators also found that participants reported greater satisfaction with the weekly regimen. According to HIV Patient Perspective of Regimen Change assessments, most participants who switched to ISL/LEN considered the once-weekly regimen less burdensome than taking daily antiretroviral medications.

Amy Colson, MD, MPH, Medical Director of the Zinberg Clinic at Cambridge Health Alliance and primary investigator for ISLEND-2, highlighted the potential quality-of-life benefits.

"The findings in the ISLEND-2 trial represent an important advance in HIV treatment. The results show that the once-weekly oral single tablet regimen of islatravir and lenacapavir maintains virologic suppression as effectively as contemporary daily oral regimens in people with well-controlled HIV-1. A once-weekly regimen has the potential to provide enhanced privacy and greater flexibility in everyday life and to reduce daily reminders of HIV status."

Although modern daily antiretroviral therapy has transformed HIV into a manageable chronic condition for many patients, investigators note that treatment preferences vary considerably. Less frequent dosing may help some individuals better integrate therapy into their daily lives while reducing treatment burden.

Long-acting injectable therapies have already demonstrated that many patients value alternatives to daily pills. If approved, ISL/LEN would introduce another option by offering long-acting treatment without injections, requiring only one oral dose each week.

The findings also reinforce continued innovation in HIV care, where treatment decisions increasingly incorporate patient preferences alongside efficacy and safety.

The ISLEND-1 and ISLEND-2 findings were featured during the AIDS 2026 press program and presented as late-breaking oral abstracts during the conference. The Phase 3 data were also published simultaneously in 

Gilead and Merck announced they plan to include these findings in upcoming regulatory submissions. If approved, the once-weekly islatravir/lenacapavir regimen would become the first long-acting oral HIV treatment for adults with virologically suppressed HIV, offering a new option that combines durable viral suppression with a simplified weekly dosing schedule.

Phase 3 ISLEND trials presented at AIDS 2026 found an investigational once-weekly oral HIV regimen maintained viral suppression comparable to daily therapy while improving treatment satisfaction and flexibility.


AIDS 2026: Long-Acting Weekly Oral HIV Therapy Advances Toward Regulatory Review 

When reports of foodborne illness begin appearing across multiple states, identifying the contaminated product is rarely straightforward. Investigators often start with little more than patients describing meals they ate weeks earlier, then painstakingly reconstruct supply chains that can span continents before determining where contamination likely occurred.

During a recent American Association for the Advancement of Science media briefing, Craig Hedberg, PhD, professor at the University of Minnesota, and Kalmia Kniel, PhD, professor of microbial food safety at the University of Delaware, explained how public health officials investigate foodborne outbreaks and why the ongoing Cyclospora outbreak illustrates both the strengths and limitations of today's food safety system.

Although much public attention focuses on recalls and case counts, both experts emphasized that outbreak investigations represent a complex collaboration among local and state health departments, the CDC, the Food and Drug Administration (FDA), clinical laboratories, growers, processors, and epidemiologists.

A Unique Pathogen Presents Unique Challenges

 is a protozoan parasite with biological characteristics that complicate both prevention and investigation.

"Cyclospora is really unique," Kniel said. "It is a single-celled protozoan parasite. It's not a bacterium."

She explained that Cyclospora requires a human host to reproduce and is shed only by infected individuals through feces. Even then, newly shed oocysts are not immediately infectious. Instead, they require approximately 7 to 14 days in the environment before they mature and become capable of causing illness.

That delayed maturation distinguishes Cyclospora from many other foodborne pathogens and influences how contamination occurs.

Fresh produce remains particularly vulnerable because it is frequently consumed raw, eliminating the cooking step that would normally destroy many pathogens. At the same time, modern agricultural distribution systems combine products from numerous farms before shipping them nationwide, making traceback investigations considerably more difficult.

"We are really fortunate to have access to so many different types of fresh fruits and vegetables," Kniel said. "But without that cooking step, we don't have a chance to kill any pathogens that could be present."

Consumers frequently ask why contaminated produce reaches grocery stores despite extensive food safety programs.

"We cannot visually see contamination by bacteria or by Cyclospora or norovirus," she explained.

Instead, contamination often remains undetected until multiple illnesses appear and public health officials recognize an unusual pattern. Environmental monitoring programs can occasionally identify contamination before illnesses occur, but testing alone cannot guarantee food safety.

"We can't test our way really to food safety," Kniel said. "If we tested all the food, we'd have nothing to eat."

Instead, prevention depends on strong worker hygiene programs, sanitation, environmental monitoring, pest management, and continual employee education throughout the food production process. Understanding why these measures matter is as important as implementing them.

"Training is really critical," she said. "Making sure that people understand the why."

Once illnesses are reported, epidemiologists begin what Hedberg described as the fundamental work of outbreak investigation.

"The basic process of epidemiology is talking to the people who got sick initially," Hedberg said.

Investigators ask detailed questions about symptoms, illness onset, restaurants visited, grocery purchases, and foods consumed during the days or weeks before illness developed. Because Cyclospora has a relatively long incubation period, investigators often review food exposures covering approximately 2 weeks.

Those interviews are then compared across hundreds or even thousands of patients.

The challenge is determining which foods truly stand out.

"If you are interviewing 10 people and 7 of them say they ate lettuce, that might seem like a lot," Hedberg explained. "But in fact, that's about the rate at which we generally consume lettuce."

Investigators, therefore, collect increasingly detailed information, including restaurant names, grocery stores, product varieties, and brands. They may also compare patients with healthy control groups to determine whether certain foods were consumed more frequently among those who became ill.

Once investigators identify likely food vehicles, FDA traceback specialists begin reconstructing the product's journey through the supply chain.

"The tracebacks always start with the individual information we're getting from the cases," Hedberg said.

Investigators work backward from restaurants or grocery stores to distributors, processors, and ultimately the farms where products originated.

However, modern food distribution rarely follows a single, uncomplicated path.

Distributors frequently receive products from multiple processors, while prepared foods such as salads or salsas may contain several ingredients originating from different suppliers.

"If we can't figure out which of those ingredients might have been the source," Hedberg said, "FDA might wind up tracing two or three different food items."

Every additional supplier introduces more uncertainty, making traceback investigations both labor intensive and time consuming. Ironically, investigators often become more confident as outbreaks grow because additional cases provide stronger epidemiologic evidence connecting contaminated products.

Why Cyclospora remains especially difficult to investigate

Laboratory technology has revolutionized outbreak investigations for many bacterial pathogens.

Whole genome sequencing now allows investigators to determine whether bacterial isolates from patients are genetically related, strengthening epidemiologic evidence.

Cyclospora presents a different challenge.

Because the parasite cannot be cultured easily, laboratories have limited material available for genetic analysis. Few laboratories possess the specialized expertise required to perform advanced molecular characterization.

"We just don't have the ability to say that this group of 5 Cyclospora cases [are] all related," Hedberg explained.

Instead, investigators rely more heavily on illness timing, geography, and patient interviews than they would for bacterial outbreaks.

Modern Surveillance Has Improved, but Resources Remain Essential

Both experts noted that foodborne disease surveillance has improved substantially during the past 2 decades.

Clinical laboratories increasingly use multiplex PCR panels that simultaneously detect more than 20 gastrointestinal pathogens, dramatically improving diagnosis and reporting.

Food companies also maintain sophisticated electronic traceability systems documenting product movement throughout the supply chain.

"We have a lot of new laboratory techniques," Hedberg said, noting that many illnesses previously would have gone undiagnosed.

However, technology alone cannot replace experienced investigators.

Hedberg emphasized that outbreak investigations still depend heavily on trained epidemiologists, laboratorians, and public health personnel.

"Our workforce is frequently a limiting factor," he said.

Recent reductions in federal and state public health funding, he warned, threaten both laboratory capacity and outbreak response.

"If we really want to invest in our ability to improve our capability of responding," Hedberg said, "a lot of it is going to be to invest in the workforce."

Another challenge lies in communicating investigations that continue to change as new information becomes available.

Kniel encouraged journalists to emphasize that outbreak investigations are dynamic.

"I think it's important to share with consumers that this investigation is ongoing," she said.

Early epidemiologic signals may point toward one product, only for additional evidence to reveal multiple contaminated foods or separate outbreaks occurring simultaneously.

Hedberg pointed to the current Cyclospora investigation as an example. Early evidence linked illnesses to shredded lettuce supplied to Taco Bell locations, prompting recalls. As additional cases emerged, investigators recognized that the recalled product likely represented only part of a more complicated outbreak.

"The outbreak investigation matures," Hedberg said, "and we're beginning to have better ways to look at the foods that were in distribution."

Despite ongoing investigations, neither expert recommends avoiding fresh produce altogether.

"This is a big outbreak," Hedberg acknowledged, "but the vast majority of produce moving through our markets is not part of this outbreak."

Avoiding fruits and vegetables entirely could create greater long-term health risks than the outbreak itself.

Instead, both experts encouraged consumers to follow standard food safety practices, including hand hygiene, preventing cross-contamination, proper refrigeration, and paying attention to recall notices.

Kniel noted that individuals at particularly high risk or those with compromised immune systems can further reduce risk by cooking produce when appropriate because heat effectively destroys Cyclospora.

She also encouraged consumers to continue supporting local producers while recognizing that no food production system can eliminate risk completely.

For both experts, Cyclospora serves as more than a current public health challenge. It represents an opportunity to strengthen future prevention efforts.

Kniel called for greater investment in scientific research, workforce training, sanitation infrastructure, traceability, and transparency throughout the food system.

"We need investments in science and research," she said.

Hedberg broadened that message beyond U.S. borders. "We do live in a global food system," he said. "The investments in safe water and sanitary sewage disposal that we want to make here, it's important that we support those in the countries outside of the United States that are also producing food for us."

Ultimately, both experts argued that every outbreak investigation contributes valuable knowledge that improves future prevention. By identifying previously unrecognized contamination pathways, strengthening surveillance systems, and refining traceback methods, today's investigations help reduce tomorrow's risks.

As food supply chains become increasingly global and complex, those investments in epidemiology, laboratory science, environmental health, and public health infrastructure will remain central to protecting consumers and maintaining confidence in the safety of the food supply.

Food safety experts explain how epidemiology, traceback investigations, surveillance, and food safety practices work together to identify contamination sources during Cyclospora outbreaks while highlighting ongoing challenges in protecting the food supply.

Cyclospora Outbreak Highlights the Science Behind Foodborne Disease Investigations

, working with the CDC and state health departments, has expanded its investigation into 

 linked to recalled iceberg lettuce sourced from central Mexico. The outbreak now includes 9 states, with 1,947 laboratory-confirmed illnesses and at least 98 hospitalizations, making it one of the largest Cyclospora outbreaks investigated in the United States. No deaths have been reported.

For infection preventionists (IPs), the outbreak serves as a reminder that foodborne pathogens are not confined to restaurants or grocery stores. Health care facilities, particularly those that prepare or serve fresh produce, must remain vigilant when food recalls involve products commonly used in patient meals, cafeterias, and long-term care settings.

According to the FDA, illnesses included in this investigation are linked to exposure 

at Taco Bell restaurants and have been reported in Illinois, Indiana, Kansas, Kentucky, Michigan, Ohio, Oklahoma, Pennsylvania, and West Virginia.

 Illness onset dates range from June 22 through July 20, 2026. Officials expect the case count to continue to rise because it can take up to 6 weeks for investigators to determine whether newly reported illnesses are part of the outbreak.

The investigation prompted Taylor Farms de Mexico to voluntarily remove all iceberg lettuce sourced from central Mexico from the US market on July 17. 

The recall includes Marketside-brand iceberg salad and shredded lettuce products sold at Walmart,

 as well as numerous foodservice products distributed to restaurants, institutional kitchens, and other commercial customers. Product distribution has been confirmed across 28 states, underscoring the importance of reviewing food inventories even in states without confirmed illnesses.

For hospitals and other health care organizations, IPs may want to work with dietary services, supply chain teams, and environmental health personnel to verify that recalled products have been removed from inventory and that foodservice vendors are aware of the recall. Although Cyclospora is not spread person-to-person through routine patient care, recognizing foodborne outbreaks remains an important component of infection prevention and public health surveillance.

The FDA also clarified a laboratory finding that briefly created confusion during the investigation. An iceberg lettuce sample initially reported as positive for 

 was later determined to be a false positive after additional laboratory review. The agency emphasized that this does not change the epidemiologic evidence or traceback investigation, both of which continue to implicate shredded iceberg lettuce supplied by Taylor Farms de Mexico.

Cyclospora causes cyclosporiasis, a gastrointestinal illness

 characterized by prolonged watery diarrhea, abdominal cramping, bloating, nausea, fatigue, weight loss, and decreased appetite. Symptoms may persist for weeks or recur if untreated. Immunocompromised patients are at increased risk for prolonged illness and complications, making early recognition particularly important in hospitals caring for transplant recipients, oncology patients, and others with weakened immune systems.

Although health care-associated transmission is not expected, clinicians and IPs should consider Cyclospora infection in patients presenting with persistent diarrheal illness

 who have recently consumed fresh produce or eaten at establishments receiving recalled products. Prompt diagnosis not only improves patient management but also supports public health investigations by helping identify additional outbreak-associated cases.

The FDA continues to advise consumers, retailers, restaurants, and institutional foodservice operators not to consume, serve, or distribute recalled iceberg lettuce products. The agency also recommends cleaning and sanitizing surfaces and containers that may have come into contact with recalled products to reduce the risk of cross-contamination.

As traceback activities continue, the FDA cautioned that additional brands, retailers, restaurants, or distribution channels may be identified. For infection preventionists, staying informed about evolving food recalls and maintaining close collaboration with nutrition services and facility leadership can help ensure recalled products do not reach vulnerable patient populations.

The FDA has expanded its Cyclospora outbreak investigation to 9 states. Infection preventionists should review food safety protocols, vendor recalls, and surveillance for prolonged diarrheal illness.

FDA Expands Cyclospora Outbreak Investigation to 9 States as Nearly 2,000 Confirmed Cases Highlight Challenges for Health Care Facilities

(Adobe Stock 112538011 by Vitalii Vodolazskyi)

Atea Pharmaceuticals has completed enrollment in its phase 3 C-FORWARD clinical trial, marking a significant milestone in the company's global hepatitis C virus (HCV) development program and advancing efforts to evaluate a potential new treatment option designed to simplify care and improve access.

The C-FORWARD study is one of 2 pivotal phase 3 trials evaluating the investigational oral combination of bemnifosbuvir and ruzasvir in adults with chronic HCV infection. Together with the companion C-BEYOND study, the program is the first global head-to-head phase 3 comparison of direct-acting antiviral (DAA) regimens in HCV, comparing the investigational therapy with the current standard of care.

According to the company, the clinical program is designed to support the growing emphasis on a "test-and-treat" model, which aims to rapidly diagnose patients and initiate treatment, an approach considered essential to achieving the World Health Organization's goal of eliminating hepatitis C as a public health threat.

"Completing enrollment in C-FORWARD is a meaningful milestone for our global phase 3 HCV program, bringing us one step closer to a regimen designed around the unique needs of people living with HCV and the test-and-treat model that is critical to advancing HCV elimination efforts,”Arantxa Horga, MD, Chief Medical Officer at Atea Pharmaceuticals, told 

. “Together, C-FORWARD and C-BEYOND represent the first global head-to-head phase 3 program of direct-acting antivirals in HCV. We believe bemnifosbuvir and ruzasvir's potential best-in-class profile with a short treatment duration, low risk of drug-drug interactions with common medications, and ability to be taken with or without food substantially differentiates it from the current standard of care and could make it easier for patients to access and adhere to treatment. That is significant in a disease that, if left untreated, can progress to cirrhosis, end-stage liver disease, and liver cancer. HCV is a leading cause of liver cancer in the US."

Hepatitis C remains a major global public health challenge despite the availability of highly effective antiviral therapies. Although direct-acting antivirals have transformed HCV treatment by achieving sustained virologic response rates exceeding 95% in many patient populations, barriers to diagnosis, treatment initiation, medication access, and adherence continue to prevent many individuals from receiving curative therapy.

Investigational regimens that shorten treatment duration and reduce medication restrictions may help support broader treatment uptake, particularly in populations with limited access to specialty care or those taking multiple medications for other chronic conditions.

Atea's investigational combination pairs bemnifosbuvir, a nucleotide polymerase inhibitor, with ruzasvir, an NS5A inhibitor. The company believes the regimen's potential to be administered with or without food and its low potential for clinically significant drug-drug interactions could simplify treatment for patients with complex medical needs.

The completion of enrollment in C-FORWARD follows continued progress across Atea's global Phase 3 program. Data from both C-FORWARD and C-BEYOND will help determine whether the investigational regimen can demonstrate noninferior or superior efficacy compared with currently available DAA therapies while maintaining a favorable safety profile.

If successful, the program could provide clinicians with an additional treatment option that supports simplified HCV management strategies, particularly as health systems increasingly adopt decentralized screening and treatment models designed to reach underserved populations.

With hepatitis C remaining a leading cause of cirrhosis, liver failure, and hepatocellular carcinoma worldwide, expanding the availability of effective, easy-to-administer antiviral therapies remains an important component of global elimination efforts. The results of Atea's Phase 3 program are expected to further clarify whether bemnifosbuvir and ruzasvir can help address remaining gaps in HCV treatment and improve access to curative therapy for patients around the world.

Atea Pharmaceuticals completed enrollment in its Phase 3 C-FORWARD trial evaluating Bemnifosbuvir and Ruzasvir, advancing a simplified treatment approach for chronic hepatitis C.

Atea Completes Enrollment in Phase 3 Hepatitis C Trial Evaluating Bemnifosbuvir and Ruzasvir

Welcome to the ICT Expert Acronym Challenge!

Infection prevention and control (IPC) professionals work with a specialized vocabulary every single day. From tracking health care-associated infections (HAIs) through the National Healthcare Safety Network (NHSN) to implementing high-level disinfection (HLD) protocols, mastering these key acronyms is essential for effective practice.

This first challenge tests your knowledge of 

Regulatory and professional organizations

Whether you're preparing for certification, brushing up on terminology, or challenging your colleagues, this quiz is designed to reinforce the foundational knowledge that keeps patients safe. Take your time, match each acronym to its definition, and then check the complete answer key.

And look for more of these in the future. :) 

Puzzle Quizzes

Think you know your infection control acronyms?
Test your expertise with our ICT Expert Acronym Challenge! From CLABSI to VRE, this 20-question puzzle covers essential health care-acquired infection prevention terminology that every infection control professional should master.
How many can you match correctly? 
Try the challenge now! Perfect for IPC specialists, infection prevention coordinators, and health care epidemiologists!