Biomarker combinations to simultaneously evaluate non-alcoholic steatohepatitis and hepatic fibrosis status
AssigneeBio-Rad Laboratories, Inc.
InventorsIsabelle Batxelli-Molina, Florian Salipante, Roger P. Walker, John Flanagan, Jeannette Fareh-Michiel
Life of this patent
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Abstract
The invention provides a method of diagnosing Non-Alcoholic Steatohepatitis (NASH) and/or the hepatic fibrosis status of a subject, especially a subject afflicted with Non-alcoholic fatty liver disease (NAFLD) or NASH, based on the level of only three or more particular biomarkers. The invention further provides a kit suitable for performing said method and the use of said method and methods of treating patients diagnosed in accordance with the disclosed methods.
Claims5
A kit for diagnosing NASH and/or the hepatic fibrosis status of a subject comprising:
- (i) antibodies for determining, in a blood, plasma, serum, urine or cerebrospinal fluid sample obtained from a subject, levels of at least three biomarkers, said at least three biomarkers being a pro-inflammatory cytokine, a chemokine and a glycosaminoglycan contributing to cell-adhesion and tissue modeling, wherein:
- (a) the pro-inflammatory cytokine is IL-8;
- (b) the chemokine is CXCL10;
- (c) the glycosaminoglycan contributing to cell-adhesion and tissue modeling is hyaluronic acid;
- and
- (ii) instructions, said instructions disclosing:
- contacting said sample with antibodies that bind to said at least three biomarkers and determining the levels of said IL-8, CXCL10 and HA in said sample;
- calculating a value for f1(NASH) and/or f1(fibrosis), wherein
- f
- 1
-
- (
- NASH
- )
- =
- exp
-
- (
- y
- 1
-
- (
- N
-
- A
-
- S
-
- H
- )
- )
- 1
- +
- exp
-
- (
- y
- 1
-
- (
- N
-
- A
-
- S
-
- H
- )
- )
-
- wherein
-
- f
- 1
-
- (
- NASH
- )
- :
- y
- 1
-
- (
- NASH
- )
- =
- (
- -
- 2.3083
- +
- 0.4079
- ×
- IL
-
- 8
- -
- 0.0129
- ×
- HA
- +
- 0.0019
- ×
- CXCL
-
- 10
- )
-
- and
- f
- 1
-
- (
- fibrosis
- )
- =
- exp
-
- (
- y
- 1
-
- (
- fibrosis
- )
- )
- 1
- +
- exp
-
- (
- y
- 1
-
- (
- fibrosis
- )
- )
-
- where
- y
- 1
-
- (
- fibrosis
- )
- =
- (
- -
- 7.0457
- +
- 1.0511
- ×
- IL
-
- 8
- +
- 0.067
- ×
- HA
- +
- 0.0004
- ×
- CXCL
-
- 10
- )
- and
- when f1(NASH)>0.4997, the subject is diagnosed with NASH and when f1(NASH)≤0.4997, the subject is diagnosed with non-alcoholic fatty liver (NAFL) and when f1(fibrosis)>0.1953, the subject is diagnosed with advanced liver fibrosis and when f1(fibrosis)≤0.1953, the subject is diagnosed with early-moderate liver fibrosis.
Dependencies are inferred from the claim text.