Liver disease-related methods and systems
First Claim
1. A method comprising aiding in the diagnosis of the status or progress of a liver disease in a patient by determining at one or more time points a predictor value for each time point, wherein a comparison at one or more time points of the predictor value and a comparative data set is used to ascertain the status or progress of patient liver disease, and wherein patient predictor values are calculated by inputting data reflecting values of two or more blood markers, and optionally one or more supplementary markers, into a linear or nonlinear function algorithm derived by correlating reference liver histopathological and blood marker data.
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Abstract
The invention provides diagnostic methods, kits, and systems, and related computer-readable media, which use multiple blood marker values, including serum and plasma marker values, to aid in the diagnosis of the status or progress of a liver disease in a patient. The invention also provides methods and systems, and related computer-readable media, that use blood marker values, including serum and plasma marker values: (1) to screen for active ingredients useful in the treatment of a liver disease; (2) to aid in the selection of treatment regimens for patients that are predisposed to, or suffer from, liver disease; and (3) to aid in the design of clinical programs useful in monitoring the status or progress of liver disease in one or more patients.
23 Citations
34 Claims
- 1. A method comprising aiding in the diagnosis of the status or progress of a liver disease in a patient by determining at one or more time points a predictor value for each time point, wherein a comparison at one or more time points of the predictor value and a comparative data set is used to ascertain the status or progress of patient liver disease, and wherein patient predictor values are calculated by inputting data reflecting values of two or more blood markers, and optionally one or more supplementary markers, into a linear or nonlinear function algorithm derived by correlating reference liver histopathological and blood marker data.
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3. A method of claim 3, wherein the comparative data set comprises values corresponding to values determined by one or more of the following tests:
- Scheuer Score (0-4), the Modified Ishak Score (HAI) A-Interface Hepatitis (0-4), the Modified Ishak Score (HAI) B-Confluent Necrosis (0-6), the Modified Ishak Score (HAI) C-Spotty Necrosis (0-4), the Modified Ishak Score (HAI) D-Portal Inflammation (0-4), and the Modified HAI Score (Ishak Score) (0-6).
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4. A method of claiml, wherein the blood markers are serum markers which are selected from at least two or more of the following:
- N-terminal procollagen III propeptide (PIIINP), Collagen IV, Collagen VI, Tenascin, Laminin, Hyaluronan, MMP-2, TIMP-1, MMP-9/TIMP-1 complex, alanin-aminotransferase (ALT), aspartat-aminotransferase (AST).
- View Dependent Claims (5, 16)
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18. A computer readable medium having stored thereon a data structure comprising a data field containing data representing a linear or nonlinear function algorithm defined by concentration values for two or more of the following serum markers:
- N-terminal procollagen III propeptide (PIIINP), Collagen IV, Collagen VI, Tenascin, Laminin, Hyaluronan, MMP-2, TIMP-1, MMP-9/TIMP-1 complex, alanin-aminotransferase (ALT), aspartat-aminotransferase (AST).
- View Dependent Claims (19)
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20. A data structure stored in a computer-readable medium that may be read by a microprocessor and that comprises at least one code that uniquely identifies a linear or nonlinear function algorithm defined by concentration values for two or more of the following serum markers:
- N-terminal procollagen III propeptide (PIIINP), Collagen IV, Collagen VI, Tenascin, Laminin, Hyaluronan, MMP-2, TIMP-1, MMP-9/TIMP-1complex, alanin-aminotransferase (ALT), aspartat-aminotransferase (AST).
Specification