NIH Record - National Institutes of Health

FDA Grants Authorization to First Hepatitis C Test

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Hepatitis C concept with 3D virus cells attached to an illustration of a human liver
Hepatitis C concept with 3D virus cells attached to an illustration of a human liver

The FDA has granted marketing authorization for the first point-of-care hepatitis C RNA test, which was validated in part by NIH Rapid Acceleration of Diagnostics (RADx) Tech. This game-changing rapid test that can be used in patient care settings delivers results in about an hour. 

This new technology could help patients who test positive for the disease get treated right away rather than the current approach, which requires lengthy laboratory processing.

The RADx Tech program aims to speed development, validation and commercialization of innovative virus testing. 
For more information, see: go.nih.gov/TBWV4Ok

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