FDA action increases the prospect for bringing hepatitis B screening one step closer to those who lack access to care
A potentially significant public health tool, POC testing has been used in Europe and Asia for years.
Doylestown, Pa., Oct. 2, 2024 – The U.S. Food and Drug Administration (FDA) recently posted a proposed rule, “Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices,” down-classifying hepatitis B screening and diagnostic tests from class III to class II. This increases the likelihood that point-of-care (POC) testing for hepatitis B in the U.S. will be made available, which is instrumental to improving access to testing for the disease.
A related announcement came about the same time from the National Institute of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Tech program. In collaboration with the FDA, the program is soliciting proposals “to accelerate the validation, regulatory authorization and commercialization of innovative point-of-care (POC) tests for hepatitis B virus surface antigen (HBsAg) detection,” the announcement said.
Hepatitis B Foundation President Chari A. Cohen, DrPH, MPH, applauded these steps by the FDA and NIH. For nearly two years, the Foundation and its partners have been advocating for reclassifying screening tests for hepatitis B.
“This is excellent news,” she said. “The FDA listened to what we and others have been saying for some time, which is that POC testing is extremely necessary for improving diagnosis of those living with hepatitis B who are unaware of their status. These low-risk tests would be a critical asset in our continuing fight against hepatitis B in the U.S., where conventional lab testing continues to be a burden to diagnosis, particularly among underserved communities with health care access challenges. The value and reliability of these tests have been proven in Europe and Asia, where POC testing has been used for years.”
The FDA said it plans to reclassify several types of qualitative and quantitative hepatitis B tests as moderate risk Class II devices from their current classification as high-risk Class III devices. That action would significantly lower the barriers for entry currently facing diagnostic companies that want to market POC testing for hepatitis B in the U.S.
The Hepatitis B Foundation met with the FDA two years ago and provided evidence requested by the agency that demonstrated the need for POC testing and its key role in early diagnosis. The Foundation led a nationwide public comment effort on this issue last year that engaged allies across public health and health care.
Three Hepatitis B Foundation experts – Dr. Robert Gish, Dr. Yasmin Ibrahim and Dr. Su Wang – testified at an FDA public hearing on the value of down-classifying for hepatitis B tests last fall. And the Foundation is communicating with federal officials and working with allies currently to provide additional input supporting the proposed reclassification.
The FDA is hosting an open public comment period for the new proposed re-classification rule. The Hepatitis B Foundation will be submitting comments and encourages all stakeholders to submit comments here.