Notably, in 2018, the first-generation Elecsys β-Amyloid(1–42) CSF and Phospho-Tau (181P) CSF immunoassays were granted United States Food and Drug Administration Breakthrough Device Designation to support the improved diagnosis of AD in concordance with amyloid PET visual read result [48]; this was followed by United States Food and Drug Administration approval for the second-generation Elecsys β-Amyloid(1–42) CSF II and the updated Elecsys Phospho-Tau (181P) CSF immunoassays on December 8, 2022 [49]. The gene discussed is MAPT; the disease is Alzheimer disease.