OraSure Technologies Inc. took a step forward in its bid to bring to market its OraQuick In-Home HIV Test. If approved, OraQuick would be the first over-the-counter HIV test that lets people get results without using a doctor or laboratory. The FDA Blood Products Advisory Committee unanimously determined that the benefits of the saliva test outweigh the risks. The primary risk being false negative results.
Final-phase trials of the OraQuick home test are reported to have found 5,384 of 5,385 negative users resulting in one false positive, and 106 of 114 confirmed positive users resulting in eight false negatives. Reports indicate that OraQuick would potentially produce one false negative result for every 13 true positive tests. The FDA suggested that the product’s labeling be enhanced to ensure people understand the risk of false negative results.
OraSure is faced with the task of incorporating the FDA’s suggestions into its labeling in such a way that consumers will understand the risks. It is critical that labeling on over-the-counter diagnostic devices meet regulatory standards and be easily understood by consumers, without the benefit of their physician. Failure to incorporate adequate instructions and warnings in the labeling could hinder approval and lead to lawsuits down the road.
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