Early diagnosis of conformational diseases
AssigneeLaboratories Serono SA
InventorsClaudio Soto, Gabriella Saborio
Life of this patent
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Abstract
A method for the diagnosis or detection of conformational diseases by assaying for a marker (the pathogenic conformer) of such diseases in a sample is described, which method comprises a cyclic amplification system to increase the levels of the pathogenic conformer which causes such diseases. In particular, such transmissible conformational diseases may be prion encephalopathies. Assays, diagnostic kits and apparatus based on such methods are also disclosed.
Claims12
A method for the detection of a conformational disease which is characterized by a conformational transition of Prion Protein between the PrPC non-pathogenic conformer and the PrPSC pathogenic conformer, by assaying a marker of said disease within a sample, which method comprises:
- (i) contacting said sample with an amount of the PrPC non-pathogenic conformer;
- (ia) incubating said sample with said PrPC non-pathogenic conformer;
- (ii) disaggregating any aggregates eventually formed during step (i);
- and
- (iii) determining the presence and/or amount of said PrPSC pathogenic conformer within the sample, the pathogenic conformer being a marker for the presence of said disease, wherein steps (ia) and (ii) form a cycle which is repeated at least twice before carrying out step (iii).
The method of any one of the preceding claims, wherein the sample to be analysed is subjected to a pre-treatment for selectively concentrating the PrPSC pathogenic conformer in the sample.
An assay for a marker of a conformational disease which is characterized by a conformational transition of Prion Protein between the PrPC non-pathogenic conformer and the PrPSC pathogenic conformer, within a sample, which assay comprises the following steps:
- (i) contacting said sample with an amount of the PrPC non-pathogenic conformer;
- (ia) incubating said sample with said PrPC non-pathogenic conformer;
- (ii) disaggregating any aggregates eventually formed during step (i);
- and
- (iii) determining the presence and/or amount of said PrPSC pathogenic conformer within the sample, the PrPSC pathogenic conformer being a marker for the presence of said disease, wherein steps (ia) and (ii) form a cycle which is repeated at least twice before carrying out step (iii).
A method for identifying a compound which modulates the conformational transition of Prion Protein between the PrPC non-pathogenic conformer and the PrPSC pathogenic conformer, comprising:
- (i) contacting an amount of the PrPC non-pathogenic conformer with an amount of the PrPSC pathogenic conformer (a) in the presence of said compound and (b) in the absence of said compound;
- (ii) disaggregating any aggregates eventually formed during step (i);
- and
- (iii) determining the amount of the PrPSC pathogenic conformer (a) in the presence of said compound and (b) in the absence of said compound.
A method for detecting the presence of a PrPSC pathogenic form of Prion Protein within a sample, comprising:
- (i) contacting the sample with an amount of the PrPC non-pathogenic prion protein;
- (ia) incubating the sample with the PrPC non-pathogenic prion protein;
- (ii) disaggregating any aggregates formed during step (ia);
- repeating steps (ia)-(ii) two or more times;
- and then
- (iii) determining the presence and/or amount of PrPSC pathogenic prion protein within the sample.
Dependencies are inferred from the claim text.