Qualification of M30 and M65 ELISAs as surrogate biomarkers of cell death: long term antigen stability in cancer patient plasma.
OBJECTIVE
M30 and M65 ELISAs are proposed as surrogate biomarkers of tumour cell death in patients and are being applied increasingly in the pharmacodynamic (PD) evaluation of anticancer drugs during clinical trials. In the absence of such data, we have studied the long-term stability of the antigens of both assays in plasma of cancer patients stored at -80 degrees C over 2 years.


RESULTS
No evidence was detected of degradation in the M65 antigen. However, in a proportion of patients significant increases in levels of M30 antigen were detected


CONCLUSIONS
Plasma samples for M65 analysis can be stored at -80 degrees C for 2 years; however, caution is recommended when considering long-term storage of samples for the M30 assay.
Cummings
J
J
Clinical and Experimental Pharmacology Group, Paterson Institute for Cancer Research, University of Manchester, Wilmslow Road, Manchester, M20 4BX, England. jcummings@picr.man.ac.uk
Ranson
M
M
Butt
F
F
Moore
D
D
Dive
C
C
D000951:Antigens, Neoplasm / Q000097:blood / Q000378:metabolism*; D000970:Antineoplastic Agents / Q000008:administration & dosage; D017209:Apoptosis; D014408:Biomarkers, Tumor / Q000097:blood / Q000378:metabolism*; D016923:Cell Death; D002498:Centrifugation; D004354:Drug Screening Assays, Antitumor; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005615:Freezing; D006801:Humans; D053538:Keratin-18 / Q000097:blood / Q000378:metabolism; D009363:Neoplasm Proteins / Q000097:blood / Q000378:metabolism*; D009841:Oligonucleotides / Q000008:administration & dosage; D013048:Specimen Handling; D013997:Time Factors
C498209:AEG 35156; D000951:Antigens, Neoplasm; D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor; D053538:Keratin-18; D009363:Neoplasm Proteins; D009841:Oligonucleotides