Table 1.
Summary of blood-based biomarkers in late-stage clinical development
| Name | Company | Measures | BDD (year) | CLIA (Year) | Launch | Assay type | Context of use |
|---|---|---|---|---|---|---|---|
| PrecivityAD | C2N Diagnostics, St. Louis, MO, USA | age, Aβ42/40 and APOE proteotype | Yes (2018) | Yes (2020) | 2020 | Immunoprecipitation and liquid chromatography mass spectrometry | Adults presenting with cognitive impairment, not stand-alone, must be ordered through health care provider |
| LucentAD | Quanterix, Billerica, MA, USA | pTau181 | Yes (2021) | Yes (2018) | 2023 | Simoa® immunoassay | Adults presenting with cognitive impairment, not stand-alone, must be ordered through health care provider |
| Elecsys Amyloid Plasma Panel | Roche Diagnostics, Indianapolis, IN, USA | pTau181 and APOE proteotype | Yes (2022) | Unknown | Unknown | Cobas® immunoassay | Adults presenting with cognitive impairment, not stand-alone, ordering mechanism unknown |
| AlzoSure Predict | Diadem SpA, Milan, LOM, IT, and Palo Alto, CA, USA | p53 | Yes (2022) | Unknown | Unknown | Immunoprecipitation and liquid chromatography mass spectrometry | Inclusion criteria unknown, stand-alone status unknown, ordering mechanism unknown |
| SOBA-AD | AltPep, Seattle, WA, USA | Aβ42 (oligomers) | Yes (2022) | Yes (unknown) | Unknown | ELISA | Inclusion criteria unknown, stand-alone status unknown, ordering mechanism unknown |
| AD-Detect | Quest Diagnostics, Secaucus, NJ, USA | Aβ42/40 | unknown | Yes (unknown) | 2023 | Immunoprecipitation and liquid chromatography mass spectrometry | Adults with a family history of AD, brain trauma, other risk factors (excessive alcohol consumption) or presenting with cognitive impairment, not stand-alone, can be ordered directly by consumer |
Abbreviations: Aβ, amyloid-β; AD, Alzheimer’s disease; BDD, Breakthrough Device Designation; CLIA, Clinical Laboratory Improvement Amendments; ELISA, enzyme-linked immunoassay.