As global funding for hepatitis C virus (HCV) testing has been deemed "insufficient," ensuring continued access to essential diagnostics and care for patients is more critical than ever. Here, we hear from Jennifer Rakeman-Cagno, Senior Director of Medical Affairs and Public Health Programs at Cepheid, who shares how innovative diagnostics are helping to close the access gap for HCV patients.
From your perspective, what are the biggest diagnostic challenges laboratories face in identifying HCV infections today?
The greatest challenge in the US has been reaching those most at risk and ensuring they have access to testing, treatment, and support. Until recently, the diagnostic pathway for HCV infection required two steps: an initial antibody test to detect past or current infection, followed by confirmatory RNA testing if the antibody result was positive. This process could take days or weeks to complete and often required multiple clinic visits before a diagnosis was confirmed and treatment began. As a result, many patients were lost at various stages of testing. The traditional approach could also miss early infections, as antibodies are not yet detectable in the acute phase, which can last for weeks or months and carries a high risk of viral transmission.
Current guidance from the US Centers for Disease Control and Prevention (CDC) recommends “auto-reflex” testing, where a single specimen is submitted, and any positive antibody result is automatically sent for confirmatory RNA testing. While this approach shortens turnaround time, patients typically still need at least two visits to complete testing, receive results, and start treatment.
Today, the main challenge in HCV diagnostics lies not in technology but in access – ensuring testing is available to those at highest risk. Moving testing from centralized laboratories to decentralized or community-based settings allows patients to be tested, diagnosed, and started on treatment in a single visit. This approach reduces barriers to care and encourages testing in low-threshold environments where patients feel supported. As more people learn their HCV status and begin treatment promptly, engagement improves, and the spread of infection can be significantly reduced.
Which patient populations remain underserved by current HCV diagnostic strategies, and what specific barriers contribute to these diagnostic gaps?
The populations most underserved by current HCV strategies are also those with the highest rates of infection – people who use drugs, individuals experiencing homelessness, Indigenous populations, and those who are incarcerated. Barriers such as limited access to healthcare, stigma, and competing daily needs (for example, securing food and shelter) make it difficult for many to seek testing. Existing diagnostic approaches are complex and often require multiple clinic visits, leading many patients to drop out before they can begin treatment.
Outside the US, point-of-care (POC) HCV testing has proven highly effective in reaching, diagnosing, and treating patients in community settings. One example is the Kombi Clinic in Australia, where healthcare workers bring testing and treatment directly to people using a VW van. The team sets up at harm reduction centers, soup kitchens, and even music festivals to provide on-the-spot HCV RNA testing and treatment from the mobile unit.
In the US, similar decentralized “test-and-treat” models are beginning to show success. Programs such as the UCSF DeLIVER van, the La Bodega Clinic in Buffalo, New York, and initiatives led by Jennifer Havens at the University of Kentucky are bringing testing and care to patients in harm reduction and community settings. These low-threshold models – offering testing, treatment, and supportive services in a single visit – are helping overcome barriers, engage more patients, and ultimately move closer to curing HCV in high-risk populations.
How have recent funding cuts affected diagnostic capacity and disease surveillance?
Funding for HCV programs in the US has declined even as case numbers have continued to rise. Efforts to eliminate HCV have been consistently limited by insufficient resources. In addition, barriers to insurance coverage for both testing and treatment make it difficult for patients to access life-saving care. The lack of sustained public health investment has left many underserved populations without adequate testing or treatment options, while surveillance systems remain under-resourced and fragmented.
In 2023, Rachael Fleurence and Francis Collins, then serving at the White House, outlined the need for a National Hepatitis C Elimination Program. They emphasized that the tools to achieve elimination already exist: direct-acting antivirals (DAAs) that can cure HCV in weeks and reliable diagnostic technologies to identify those in need of treatment. In 2025, the bipartisan Cure Hepatitis C Act was introduced by Senators Bill Cassidy and Chris Van Hollen. The proposed legislation would allocate $9.7 billion to fund widespread diagnostic testing, expand treatment access, and strengthen the necessary infrastructure and support services. Over a decade, the initiative is projected to pay for itself and save an estimated $7 billion by preventing severe liver disease, liver cancer, transplants, and premature death. Despite its potential impact, the bill has not yet been passed.
In mid-2025, the Substance Abuse and Mental Health Services Administration (SAMHSA) launched the Hepatitis C Elimination Pilot Initiative. This three-year, $98 million grant program funds 19 organizations serving populations at high risk for HCV infection, including Indian Health Service sites. The initiative focuses on building decentralized, test-and-treat models of care, where patients can be tested, diagnosed, and started on treatment in a single visit. Each program will be evaluated on the number of patients tested, treated, and cured. The success of these pilot programs may demonstrate that national HCV elimination is achievable – and provide a foundation for broader implementation across the US.
How can cross-sector collaboration strengthen HCV diagnostic efforts?
Public–private partnerships are essential to the success of HCV elimination efforts and will remain so in the years ahead. The same-day test-and-treat model required for elimination depends on the ability to diagnose infection at the POC – both in clinical settings and in decentralized or community-based environments. While POC RNA testing for HCV has been available internationally for several years, it was not introduced in the US until 2024. This followed the US FDA reclassification of HCV diagnostic tests in November 2021, which allowed their use in CLIA-waived settings.
The National Institutes of Health (NIH) established the Rapid Acceleration of Diagnostics (RADx) and Independent Test Assessment Program (ITAP) during the COVID-19 pandemic to accelerate the development and deployment of high-quality diagnostics. These programs have since expanded to support responses to other public health challenges, including the 2022 US mpox outbreak. In 2023, ITAP announced an initiative to develop POC HCV RNA tests aligned with the goals of a national hepatitis C elimination strategy.
Collaboration among federal agencies – including ITAP, NIH, FDA, CDC, the Centers for Medicare & Medicaid Services (CMS), and the White House – alongside diagnostic manufacturers, led to the rapid development, authorization, and deployment of the first POC HCV RNA tests in the US. The launch of these tests in 2024 marked a key milestone toward enabling same-day diagnosis and treatment initiation for HCV infection.
Updated test-and-treat guidance developed in partnership with the CDC and the American Association for the Study of Liver Diseases/Infectious Diseases Society of America (AASLD/IDSA) now incorporates the use of POC RNA diagnostics. However, despite these technological and policy advances, the US still lacks the dedicated funding needed to implement a coordinated national elimination program that integrates testing, treatment, and comprehensive support services.
What emerging diagnostic tools or technologies do you believe hold the most promise for closing the access gap in HCV testing?
Reaching patients where they are is essential for improving access to HCV testing and treatment – and for advancing equitable healthcare more broadly. Providing care in low-threshold, non-stigmatizing settings that are convenient and welcoming to patients is key. However, connecting patients in highly decentralized settings with a clinician who can prescribe HCV treatment can still be challenging.
The expansion of telemedicine during the COVID-19 pandemic has helped address this barrier, allowing patients to consult with healthcare providers remotely and begin treatment without visiting a clinic. Combined with POC testing that can be performed by community health workers in mobile units – or even from a car – these advances make it possible to bring diagnostic and treatment services directly to patients. With accessible testing, telehealth support, and fewer administrative barriers, care can truly reach people where they are.
Could innovations in sample collection help extend testing into underserved communities?
For many reasons, some patients are unwilling or unable to undergo a venous blood draw, and venous collection is not feasible in all settings. The ability to test using capillary “fingerstick” blood expands access by allowing testing in a wider range of environments. Fingerstick samples can be collected without a trained phlebotomist and are suitable for use in encampments, harm reduction centers, and other non-clinical locations.
Dried blood spots are another practical option – they are easy to collect, stable during transport, and useful for remote sampling – though they typically require laboratory processing. Expanding the range of specimen collection and testing options, both in laboratories and in the field, increases opportunities to reach more patients and provide timely diagnosis and care.
In your view, what is the most important role pathologists and laboratory professionals can play in moving us closer to HCV elimination?
Decentralized, non-laboratory-based testing is essential for HCV elimination, but, used in isolation, it's not enough. Laboratory-based testing remains a critical component of diagnosis and care. Laboratories will need to maintain efficient testing workflows, including clinician decision-support tools and auto-reflex testing to confirm infection. Beyond confirming HCV, additional testing for co-infections such as hepatitis B virus (HBV) and HIV, as well as liver function and disease status, is vital for comprehensive patient evaluation – particularly for those with co-morbidities.
Laboratory professionals and pathologists also play a key role in educating clinicians and care teams about diagnostic strategies and test interpretation. Equally important, laboratories are central to diagnostic innovation. Many new technologies originate from identified needs or discoveries within the clinical laboratory, and data on test performance and outcomes come from laboratory practice. Continued collaboration between laboratory professionals, clinicians, and diagnostic developers is essential to improving test quality, supporting the adoption of new technologies, and advancing patient care.
What do you think are the priorities for HCV diagnostics in the next 10 years?
The National Hepatitis C Elimination Plan aims to eliminate the condition as a public health problem in the US by 2030. However, current progress indicates that this goal will not be achieved without significant federal investment. While effective diagnostic tests and curative treatments are already available, the infrastructure and public health coordination needed to deliver them broadly remain insufficient. Legislative action – such as passing the Hepatitis C Cure Act – would provide the funding required to move meaningfully toward elimination.
The Viral Hepatitis National Strategic Plan outlines five key goals:
Prevent new infections.
Improve health outcomes for people with viral hepatitis, including access to testing and treatment.
Reduce disparities and health inequities related to viral hepatitis.
Strengthen surveillance and data systems.
Achieve integrated, coordinated action among all partners.
Reaching these goals will require sustained collaboration and funding at the federal, state, and local levels.
Looking ahead, the priority for the next decade is to establish and fund a comprehensive national elimination plan. Ensuring equitable access to available diagnostic technologies and highly effective treatments will be essential. Progress toward HCV elimination must also be made in the broader context of the syndemic of hepatitis C and substance use disorder, addressing both conditions through coordinated prevention, testing, and care.
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