USA – FDA finalizes biotin interfering testing guidance

A guidance document from the US Food and Drug Administration (FDA) that addresses biotin interference testing for in vitro diagnostic devices (IVDs) has been finalized. The agency left the 2019 draft guidance largely unchanged, recognizing but declining to address industry concerns seeking a lower biotin cutoff level for interference testing and asking for more explicit information about mitigation measures.

Biotin is used in many IVD scenarios, such as tests for cardiac troponin markers, where unexpectedly high serum biotin levels can cause inaccurate test results that can have serious clinical implications. Biotin supplementation is becoming more common among American consumers, who are also consuming the substance, also known as vitamin B7, at higher levels than had previously been seen.
The June 2019 draft guidance on biotin interference testing addressed the concerns of inaccurate test results by recommending sponsors contact the appropriate review division when biotin interference is detected. The draft also laid out recommendations for interference testing and communication of test results. These recommendations all carried through to the final guidance document. (RELATED: FDA Draft Guidance Seeks to Mitigate Risk of Biotin Interference, Regulatory Focus, 12 June 2019)…