It appears that regulatory agencies are pretty ignorant of predictive/diagnostic modeling. A very similar thing happened with the Japanese PMDA.
Toshi Furukawa
FDA grants breakthrough device designation for schizophrenia/bipolar bloodtests, based on below paper with n=30 per disorder, "using 'leave-one-out' analyses, indicating that the models should be predictive when applied to independent data cohorts."
Ouch.
pmc.ncbi.nlm.nih.gov/articles/PMC...
This study developed potential blood-based biomarker tests for diagnosing and differentiating schizophrenia (SZ), bipolar disorder type I (BD), and normal control (NC) subjects using mRNA gene express...
