Original Publication Date: 1 July, 2018
Publication / Source: Bioanalysis 10(13)
Authors: Booth BP, Furmanski B
In the near-term, the wide-spread use of hybrid assays appears to be ‘the next big thing’ in bioanalysis as evidenced by its inclusion in recent professional publications (Table 1) and discussions at scientific meetings. Consequently, the US FDA has been prompted to issue guidance/specifications/expectations for hybrid assays; however, regulatory experience with these modalities has been extremely scarce to date.