| |
The Urgent Need to Implement Point-of-Care RNA Testing for Hepatitis C Virus to Support Elimination
|
| |
| |
Download the PDF here
Shashi N. Kapadia,1, Ashly E. Jordan,2, Benjamin J. Eckhardt,3 and David C. Perlman2,4
1Division of Infectious Diseases, Weill Cornell Medicine, New York, New York, USA; 2Center for Drug Use and HIV/HCV Research, New York, New York, USA; 3Division of Infectious Diseases,
New York University School of Medicine, New York, New York, USA; and 4Division of Infectious Diseases, Icahn School of Medicine at Mt Sinai, New York
Abstract
Hepatitis C virus (HCV) elimination is an important global public health goal. However, the United States is not on track to meet the World Health Organization's 2030 targets for HCV elimination. Recently, the White House proposed an HCV elimination plan that includes point-of-care (POC) HCV RNA testing, which is currently in use in many countries but is not approved in the United States. POC HCV RNA testing is crucial for implementing community-based testing and for enabling test-and-treat programs, assessing cure, and monitoring for reinfection. Here, we review the status of POC HCV RNA testing in the United States, discuss factors that are needed for successful implementation, and issue specific public health and policy recommendations that would allow for the use of POC HCV RNA testing to support HCV elimination.
As of this writing, no POC HCV RNA testing platform is available for clinical use in the United States, even though this technology has been approved for use abroad since 2018 [15]. The technology to perform POC molecular testing has been supported by US public research investment. The totality of US public investment for the Cepheid GeneXpert molecular diagnostic platform, for example, was estimated to be more than $250 million [16]. Despite this significant public investment, companies such as Cepheid that have developed POC HCV RNA testing platforms have not sought regulatory approval in the United States. In general, regulatory pathways for molecular POC testing have been onerous. As a result, these critical technologies have been unavailable to medical providers, public health programs, community-based organizations, and patients who would benefit from their use.
In December 2021, the US Food and Drug Administration (FDA) reclassified HCV testing to class II, which allows manufacturers to seek approval through a less burdensome and less costly regulatory pathway. To further incentivize approval, HCV RNA is included as part of the Rapid Acceleration of Diagnostics (RADx) Independent Test Assessment Program, a fast-track program supported by the FDA and the National Institutes of Health and created to facilitate the development and distribution of COVID-19 molecular testing. A request for proposals that was launched in January 2023 is soliciting HCV POC RNA tests with the goal of accelerating the validation and authorization of these diagnostic tests [17]. Indeed, the use of POC testing using the RADx program is a key pillar of the Biden Administration's HCV elimination program agenda, as built into the White House 2023 budget proposal [18].
| |
| |
| |
|
|
|
