Recent steps by the FDA and National Institutes of Health increase the likelihood of point-of-care (POC) testing for hepatitis B virus (HBV) becoming available in the United States, according to the Hepatitis B Foundation. 

A proposed rule from the FDA down-classifies HBV screening and diagnostic tests from (high-risk) class III to (moderate-risk) class II devices. This would lower the barriers to entry for diagnostic companies planning to market POC testing for HBV in the United States.

Meanwhile, the NIH Rapid Acceleration of Diagnostics Tech program is soliciting proposals to “accelerate the validation, regulatory authorization, and commercialization of innovative” POC tests for hepatitis B.

The Hepatitis B Foundation noted that it has advocated for reclassifying screening tests for HBV for nearly two years; three of its experts testified at an FDA public hearing about down-classifying hepatitis B tests last fall.

“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,” president Chari A. Cohen, DrPH, MPH, said in a statement. “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,” Dr. Cohen added.

The FDA is hosting an open public comment period for the new proposed reclassification rule. The Hepatitis B Foundation said it will be submitting comments and encourages all stakeholders to submit comments here.


Facilitating ‘The HBV Cascade of Care’

Point-of-care HBV tests represent an alternative to laboratory-based standard-of-care (SOC) assays and are designed to accelerate diagnosis and treatment. A multinational team of investigators sought to test that design claim via a wide-ranging analysis of various information sources (Open Forum Infect Dis 2024;11[9]:ofae483).

The team searched five databases, six conference websites and contacted manufacturers for studies on the effects of HBV testing on several outcomes, including turnaround times between testing and treatment.

Six studies with nine arms were included in the analysis. Although the researchers were not able to find any head-to-head comparisons of POC versus SOC in those studies, the data they uncovered on POC were encouraging on several fronts, they noted.

“First, the time between a POC HBV DNA test and the available results was short, ranging from one hour to one day,” they wrote. “Second, studies indicate a high rate of HBV DNA VL [viral load] testing among [HBV-positive] individuals and a high rate of treatment initiation among those who qualify for treatment.”

These findings, the researchers added, “suggest that despite the lack of comparative studies, HBV POC DNA VL testing could facilitate the HBV cascade of care.”

—PPN Staff

Originally published by our sister publication Pharmacy Practice News