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Down-Classification of Hepatitis C Virus Diagnostics: Implications for Screening and Diagnosis
1Division of Gastrointestinal and Liver Diseases, University of Southern California, Los Angeles.
The Journal of Infectious Diseases
|September 22, 2023
Summary
The US FDA reclassified hepatitis C virus (HCV) diagnostic tests to class II in 2021. This change aims to speed up the availability of innovative HCV screening and point-of-care tests.
Area of Science:
- Medical Diagnostics
- Virology
- Public Health Policy
Background:
- Hepatitis C virus (HCV) diagnostics are crucial for disease management and elimination efforts.
- Previous regulatory pathways for certain HCV diagnostic tests were considered burdensome for manufacturers.
Purpose of the Study:
- To report the reclassification of two types of HCV diagnostic tests by the US FDA.
- To discuss the implications of this regulatory change for the development and accessibility of HCV diagnostics.
Main Methods:
- Review of US Food and Drug Administration (FDA) regulatory actions.
- Analysis of the impact of class II versus class III device classification.
Main Results:
- In November 2021, the FDA reclassified HCV antibody and HCV nucleic acid tests from class III to class II.
- This down-classification establishes a less stringent regulatory pathway for these diagnostic tests.
Conclusions:
- The regulatory change is expected to lower barriers for diagnostic companies.
- This facilitates innovation in HCV diagnostics, including point-of-care assays.
- The reclassification is anticipated to support HCV elimination goals by improving screening accessibility and enabling test-and-treat strategies.
