Hybrid assays: the next big thing?

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. Much of the interest in FDA guidance has been for acceptance criteria around accuracy and precision for hybrid assays. Several authors have privately and publicly promulgated the use of the ligand-binding assay (LBA) criteria (20/25%) because of the use of LBA to...