Rapid HCV Test Provides Opportunity for Single Visit Diagnosis and Treatment Encounters

Cepheid’s Xpert HCV test, authorized by the FDA for use in CLIA-waived settings in June 2024, represents an advancement in hepatitis C virus (HCV) diagnostics. The test, developed through collaboration among Cepheid, the NIH Rapid Acceleration of Diagnostics (RADx), and the Independent Test Assessment Program (ITAP), detects the full range of HCV genotypes and delivers qualitative results within an hour.

Designed for ease of use, it can be deployed in decentralized settings such as harm reduction centers, shelters, and mobile units—enabling clinicians to test, diagnose, and initiate treatment in a single visit. This eliminates the need for multiple clinic appointments and helps reach patients who may otherwise be lost to follow-up, particularly in underserved or high-risk populations.

However, achieving broad adoption of rapid testing still faces barriers, including infrastructure needs, consistent funding, and reliable public health reporting. While sites such as emergency departments, federally qualified health centers, and mobile medicine teams have already integrated the test into successful “test-and-treat” models, sustained investment is needed to scale these programs nationally.

The proposed Cure Hepatitis C Act of 2025 and the $98 million in pilot funding from SAMHSA mark promising steps toward building the infrastructure for widespread HCV testing and treatment. Rapid diagnostics not only expand access to care and reduce disease transmission but also have the potential to save billions in healthcare costs by preventing advanced liver disease and related complications. What remains essential, experts emphasize, is federal funding and a coordinated national plan to achieve HCV elimination in the United States.

Jennifer Rakeman-Cagno, PhD, senior director, Medical Affairs, Public Health Programs, Cepheid spoke to Contagion about the test's capabilities and how it can streamline the process from diagnosis to treatment.

Contagion: Can you provide an overview of Cepheid’s recent FDA approval for its test that detects the full range of known HCV genotypes in about an hour?

Rakeman-Cagno: The Cepheid Xpert HCV test received FDA authorization for use in the CLIA-waived setting in June 2024. This milestone was possible because of collaborative public-private partnerships. Cepheid partnered with the NIH Rapid Acceleration of Diagnostics (RADx) and Independent Test Assessment Program (ITAP). Collaboration between federal partners, including ITAP, NIH, FDA, CDC, CMS, and the White House, with Cepheid enabled the development, regulatory authorization, and deployment of the Xpert HCV test in a matter of months.

The test is designed to be easy to perform and can be deployed in decentralized settings, such as harm reduction centers, mobile testing units, shelters, and carceral settings. The test is able to reliably detect circulating genotypes of HCV within an hour and provides a qualitative result. Detection of HCV RNA is consistent with active infection, and the test can be used for making treatment decisions.

Contagion: How does diagnostic testing abilities foster accessibility, allowing more patients to be diagnosed and treated sooner, particularly in resource-limited settings?

Rakeman-Cagno: Before the availability of point-of-care diagnostic testing for HCV, testing had to be done in two steps, with at least one of the testing steps occurring in a centralized laboratory. First, a patient would be tested for antibodies to HCV. A positive HCV antibody result indicates a past infection that may have resolved or been treated, or a current infection. To determine if the patient needs treatment for active infection, a laboratory-based HCV RNA test must be performed. Overall, this process can take days to weeks, and the patient must visit the clinic at least two times (usually more) to be tested, diagnosed, and started on treatment. Many patients are lost to follow-up at each of the steps and never receive their diagnosis or life-saving treatment.

With the availability of an HCV RNA test that can be performed on-site while the patient is still there, we can test, diagnose, and start treatment in a single visit, and the visit site does not need to be a traditional clinical setting. We can meet patients where they are.

Contagion: Can you provide an example of how ongoing partnerships and commitments in the diagnostics space are helping to bridge the gap in HCV care?

Rakeman-Cagno: In order to meet national HCV elimination goals, we need a plan, and we need funding to implement that plan. The National Hepatitis C Elimination Program outlined by Drs Rachael Fleurence and Francis Collins, in 2023, informed the draft bipartisan Cure Hepatitis C Act that was introduced by Senators Cassidy and Van Hollen in 2025. This bill has yet to be passed and funded. However, in 2025, the Substance Abuse and Mental Health Services Administration (SAMHSA) committed $98 million total for HCV elimination pilot projects at 19 sites serving populations at high risk for HCV. This pilot funding will start to build infrastructure that will bridge the gap many face in getting HCV testing, treatment, and care.

Contagion: What are the biggest challenges to adoption of rapid testing, whether it be funding, learning curves for labs, limited capabilities?

Rakeman-Cagno: The biggest challenges to the adoption of decentralized HCV RNA diagnostic testing are building out the infrastructure for testing, treatment, and services in spaces where populations at highest risk for HCV infection present. Funding is critical, and federal funding for a national HCV elimination plan is necessary.

That said, there are many sites that have successfully implemented the test as part of a test-and-treat program. Harm reduction centers, emergency departments, federally qualified health centers, mobile testing units, and street medicine teams have implemented testing. Resources and experience are helpful for implementation, and health departments are leading successful programs to assist sites in the implementation of testing.

Importantly, we need to ensure that decentralized testing sites are able to report positive results to public health entities, as HCV is a reportable infection. Previously, all of the HCV diagnostic testing was performed in laboratories which have systems in place for public health reporting. This is a significant challenge in decentralized settings that may not have access to an electronic laboratory information system or electronic medical record that is able to automatically report positive results to public health. Maintaining this reporting is important for generating complete data for monitoring progress toward elimination, surveillance, and determining equitable distribution of testing, treatment, and support resources.

Contagion: How does rapid diagnostics improve patient care and costs overall?

Rakeman-Cagno: HCV test-and-treat programs require funding to build. These programs, however, not only save lives, but also save on healthcare costs overall. With more patients diagnosed and treated sooner, there is less time for HCV to cause significant liver damage that can lead to cirrhosis, liver cancer, the need for transplant, and death. Based on analysis of the Cure Hepatitis C Act of 2025, the proposed plan would pay for itself and save nearly $7 billion over 10 years.

In addition, HCV test-and-treat programs in decentralized settings enable more patients to access care, patients visit the clinic fewer times, and fewer patients are lost to follow-up. More patients can be tested and treated with less overall burden on the health care system.

With the launch of the Xpert HCV test, we now have the necessary tools for HCV elimination in the US—a point-of-care diagnostic test and a well-tolerated and highly effective treatment. What we are still missing is the funding for a coordinated elimination program that includes testing, treatment, and wrap-around services.