Patent ID: 8609345

Claim:
A method of diagnosing the presence of a disease, condition, or syndrome in a subject, comprising: detecting and quantitating the presence of at least one protein analyte in a preparation from a biological sample obtained from a subject suspected of suffering from a disease, condition, or syndrome, wherein the biological sample comprises formalin-fixed tissue or paraffin-embedded tissue, wherein the presence of said analyte indicates that the subject has the disease, condition, or syndrome; and wherein said preparation from a biological sample is prepared by a method comprising the steps of: (a) heating a composition comprising a histopathologically processed biological sample and a reaction buffer at a temperature from 80° C. to 100° C. for a period of time from 10 minutes to 4 hours to negatively affect protein crosslinking in said biological sample, and (b) treating the resulting composition with an effective amount of a proteolytic enzyme for a time sufficient to disrupt the tissue and cellular structure of said biological sample and to liquefy said sample, thereby producing a liquid, soluble, dilutable biomolecule lysate that is representative of the total protein content of said histopathologically processed biological sample wherein said quantitating comprises the addition of AQUA peptides to said biological sample.