Methods for remote blood collection, extraction and analysis of neuro biomarkers

A method of identifying if a subject is at risk for having or developing a neurodegenerative disease, the method comprising:

• a) obtaining a biological sample, wherein the biological sample is a blood sample derived from the subject;
• b) extracting proteins from the biological sample using a protein extraction reagent to obtain a protein-enriched extracted sample;
• c) performing an assay on the protein-enriched extracted sample, wherein the assay comprises determining a detected protein level of at least one of biomarkers:
• i) phosphorylated Tau-181 (pTau-181), ii) phosphorylated Tau-217 (pTau-217), iii) glial fibrillary acidic protein (GFAP), iv) neurofilament light chain (NFL), v) phosphorylated Tau-231 (pTau-231), vi) phosphorylated Tau-212 (pTau-212), vii) phosphorylated Tau-212+217 (pTau-217+), viii) brain-derived tau (BD-Tau), ix) 42-amino acid β amyloid (Aβ42) peptide, or x) 40-amino acid 1 amyloid (Aβ40) peptide.
• d) providing the detected levels of biomarkers to perform an evaluation step, wherein the evaluation step comprises comparing the provided detected levels of biomarkers in the protein-enriched extracted sample derived from the subject to threshold levels of biomarkers detected in a plurality of healthy subjects having normal cognitive function who have not been diagnosed with a neurodegenerative disease;
• and
• e) estimating a likelihood of the subject for having a neurodegenerative disease or developing a neurodegenerative disease, following completion of the evaluation step.

A method for treating a neurodegenerative disease in a subject in need thereof, the method comprising:

• i) determining protein levels of one or more biomarkers in a biological sample by:
• a) obtaining a biological sample, wherein the biological sample is a blood sample derived from the subject;
• b) extracting proteins from the biological sample using a protein extraction reagent to obtain a protein-enriched extracted sample;
• and
• c) performing an assay on the protein-enriched extracted sample, wherein the assay comprises determining a detected protein level of at least one of biomarkers:
• i) phosphorylated Tau-181 (pTau-181), ii) phosphorylated Tau-217 (pTau-217), iii) glial fibrillary acidic protein (GFAP), iv) neurofilament light chain (NFL), v) phosphorylated Tau-231 (pTau-231), vi) phosphorylated Tau-212 (pTau-212), vii) phosphorylated Tau-212+217 (pTau-217+), viii) brain-derived tau (BD-Tau), ix) 42-amino acid β amyloid (Aβ42) peptide, or x) 40-amino acid β amyloid (Aβ40) peptide;
• and
• ii) administering a therapy to the subject.