Header: FDA endorses use of alpha-synuclein assay in Parkinson's and synucleinopathy clinical development because of its very high diagnositc precision.
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Protein self-amplification into toxic configurations was established in Creutzfeldt-Jacob disease (prion protein; with Nobel prize) and this strange process applies to Parkinson's disease as well (alpha-synuclein protein). Many dozens of research studies have validated such dysfunctional protein pathways. For an entrance point to synucleinopathies, Wikipedia here.
The first laboratory to make a commercially available and CLIA-validated CSF synuclein assay. specific to the toxic form, is Amprion (San Diego). (The assay involves patient abnormal protein catalyzing the formation of more abnormal protein in vitro.) Now, FDA has issued a letter of support for this biomarker in clinical trials, so that patient groups can be identified earlier and more accurately, supporting the operation of clinical trials.
See the FDA letter here:
https://www.fda.gov/media/181368/download?attachment
See a press release from Amprion here:
See, for example, an 1100 patient study on the high accuracy of the alpha-synuclein test in Lancet Neurology:
https://www.discoveriesinhealthpolicy.com/2023/04/big-win-for-novel-diagnostics-clinical.html
See trade news here:
https://parkinsonsnewstoday.com/news/fda-letter-supports-use-new-alpha-synuclein-assay-trials/
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See a table of FDA letters of support for biomarkers here:
