Liver disease-related methods and systems
View Patent ↗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.
1. A method for aiding in the diagnosis of liver fibrosis comprising:
(a) obtaining a sample of body fluid from an individual;
(b) selecting two or more diagnostic markers of a dynamic process of extracellular matrix synthesis and/or extracellular matrix degradation from said sample;
(c) measuring the amount of each said selected two or more diagnostic markers in said sample to obtain a measured value for each of said selected diagnostic markers; and
(d) combining said measured value of each said selected diagnostic markers using a mathematical algorithm to obtain a liver fibrosis score.
2. The method according to claim 1 wherein said sample of body fluid is blood, serum, plasma or urine.
3. The method according to claim 1 wherein said liver fibrosis score is used to support, predict or substitute the histological score of a liver biopsy.
4. The method according to claim 1 wherein said mathematical algorithm is a discriminant function algorithm.
5. The method according to claim 4 wherein said discriminant function algorithm is a linear discriminant function algorithm.
6. The method according to claim 4 wherein said liver fibrosis score corresponds to a pathology score obtained by a histological assessment of a liver biopsy.
7. The method according to claim 6 wherein said pathology score is obtained by using any one of the following scoring systems: the Scheuer scoring system, the Ishak scoring system, the HAI scoring system, the Ludwig scoring system, or the Metavir scoring system.
8. The method according to claim 1 wherein said liver fibrosis score is at least one factor to determine a treatment strategy for said individual.
9. The method according to claim 1 wherein said liver fibrosis score is at least one factor used to monitor the efficacy of an implemented treatment strategy for said individual.
10. The method according to claim 1 wherein said liver fibrosis score is at leas one factor used to determine whether said individual should obtain a liver biopsy.
11. The method according to claim 1 wherein said liver fibrosis score is at least one factor used to distinguish liver fibrosis from liver cirrhosis.
12. The method according to claim 1 wherein said liver fibrosis score is at least one factor used to evaluate the degree of liver fibrosis in said individual.
13. The method according to claim 1 wherein at least one of said two or more selected diagnostic markers is Hyaluronan.
14. The method according to claim 1 wherein at least one of said two or more selected diagnostic markers is PIIINP.
15. The method according to claim 1 wherein at least one of said two or more selected diagnostic markers is TIMP-1.
16. The method according to claim 2 wherein said body fluid is blood, serum, plasma or urine.
17. The method according to claim 3 wherein said liver fibrosis score is at least one factor used to determine a treatment strategy for said individual.
18. The method according to claim 1 wherein said liver fibrosis score is at least one factor used to monitor the efficacy of an implemented treatment strategy for said individual.
19. The method according to claim 1 , wherein said liver fibrosis score is measured at two or more time points.