Method for Indicating a Presence or Non-Presence of Aggressive Prostate Cancer
AssigneePhadia AB
InventorsHenrik Grönberg, Martin Eklund
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Abstract
The present invention relates generally to the detection and identification of various forms of genetic markers, and various forms of proteins, which have the potential utility as diagnostic markers. By determining the level of a plurality of biomarkers and genetic markers in a patient sample, and combining the obtained values according to a predefined formula, it is possible to determine if it is likely that the patient suffers from aggressive prostate cancer. The present invention is particularly applicable only for patients having a body mass index value greater than 25.
Claims36
A method based on a redundantly designed combination of data for indicating a presence or non-presence of aggressive prostate cancer (PCa) in an individual, comprising the steps of:
- (i) Providing at least one biological sample from said individual;
- (ii) In said biological sample, analyzing
- a. a category of PCa biomarkers, by measuring a presence or concentration of each of a plurality of PCa biomarkers of said category of PCa biomarkers;
- and
- b. a category of SNPs related to PCa (SNPpc), by measuring a presence or absence of each of a plurality of SNPpc of said category of SNPpc;
- (iii) Combining data regarding said category of PCa biomarkers, to form a biomarker composite value representing the PCa biomarker-related risk of developing PCa;
- (iv) Combining data regarding said category of SNPpc, to form a SNPpc composite value representing the SNPpc-related risk of developing PCa, wherein the method allows disregarding a subset of at least 5% of the SNPpc of the SNPpc category when forming the SNPpc composite value;
- (v) Combining the biomarker composite value and the SNPpc composite value, to form an overall composite value;
- and
- (vi) Correlating said overall composite value to the presence or non-presence of aggressive PCa in said individual by comparing said overall composite value to a pre-determined cut-off value established with control samples of known aggressive PCa and benign disease diagnosis.
An assay device comprising a solid phase having immobilised thereon at least two different categories of ligands, wherein:
- the first category of said ligands binds specifically to a PCa biomarker, and includes a plurality of different ligands binding specifically to each of a plurality of different PCa biomarkers selected from at least one of PSA, iPSA, tPSA, fPSA, and hK2, and optionally MSMB and/or MIC-1;
- and
- the second category of said ligands binds specifically to a SNPpc, and includes a plurality of different ligands binding specifically to each of a plurality different SNPpc, selected from at least one of rs11672691, rs11704416, rs3863641, rs12130132, rs4245739, rs3771570, rs7611694, rs1894292, rs6869841, rs2018334, rs16896742, rs2273669, rs1933488, rs11135910, rs3850699, rs11568818, rs1270884, rs8008270, rs4643253, rs684232, rs11650494, rs7241993, rs6062509, rs1041449, or rs2405942, rs12621278, rs9364554, rs10486567, rs6465657, rs2928679, rs6983561, rs16901979, rs16902094, rs12418451, rs4430796, rs11649743, rs2735839, rs9623117 and rs138213197.
Dependencies are inferred from the claim text.