Disclosed is a non-invasive method for assessing in a subject the presence and severity of a liver lesion, or the risk of death or liver-related events, including: 1) performing at least three binary logistic regressions on at least one variable, performed on the same variable(s) but each directed to a different single diagnostic target, thereby obtaining at least three scores; 2) combining the scores from step 1) in a multiple linear regression to obtain a new multi-targeted score; 3) optionally sorting the multi-targeted score obtained in step 2) in a classification of liver lesion stages or grades, thereby determining to which liver lesion stage or grade the subject belongs based on his/her multi-targeted score. Also disclosed is a single multi-targeted non-invasive test obtained by the combination of single-targeted non-invasive tests providing a unique score and a unique classification with improved accuracy compared to single-targeted diagnostic tests.

Disclosures herein are directed to methods and compositions for predicting high- and low-risk liver disease in patients. Based on the results achieved from the methods and compositions disclosed herein, liver disease patients can be classified into a prognostic risk group, which enables early diagnosis and prevention of HCC and other lethal complications. Methods and compositions disclosed herein substantially improve the poor prognosis of subjects having or at risk for one or more liver diseases.

Disclosed are methods and systems using liquid chromatography-tandem mass spectrometry (LC-MS/MS) for the detection and/or analysis of progesterone metabolites, such as progesterone sulfates, in biological samples. In some cases, the amount of progesterone sulfate may be used to distinguish whether gestational pruritus of the skin is an early symptom of (ICP) or due to benign pruritus gravidarum.

Methods for determination of risk, previous history and/or presence of a betaretrovirus infection in a subject are described herein. Said methods may comprise incubating a biological sample from the subject, the biological sample comprising immune effector-producing cells, with one or more betaretrovirus-specific epitopes, the betaretrovirus-specific epitopes comprising at least 7 contiguous amino acids according to any one of SEQ ID Nos. 1-36, and measuring the production of immune effectors by the immune effector-producing cells, wherein production of the immune effectors by the immune effector-producing cells determines risk and/or presence of betaretrovirus infection in the subject. Isolated peptides and kits for carrying out the methods are also described.

The invention relates to methods of diagnosing, prognosing, or monitoring or staging the progression of non-alcoholic fatty liver disease (NAFLD) using biomarkers. The invention also relates to a method of scoring to determine the severity of NAFLD, and a method of treating NAFLD.

The present invention relates to the identification of a novel pathological marker, novel methods for the diagnosis or for the monitoring of the progress of non-alcoholic hepatic steatosis (NAFLD) by the detection and the quantitation of said marker, and devices enabling the implementation of said methods.

The disclosure features non-invasive methods for diagnosing non-alcoholic fatty liver (NAFL), non-alcoholic steatohepatitis (NASH), and liver fibrosis in a subject by, e.g., determining the level of one or more lipids, glycans, hormones, and/or fatty acids in a biological sample (e.g., a blood, serum, or plasma sample) obtained from the subject. Also described are methods of treating, monitoring, or evaluating the efficacy of a treatment for NAFL, NASH, or liver fibrosis in a subject based on the level of one or more lipids, glycans, hormones, and/or fatty acids in a biological sample (e.g., a blood, serum, or plasma sample) obtained from the subject.

Provided is a method of assisting the detection of nonalcoholic steatohepatitis (NASH), which is far less invasive than liver biopsy and is based on simple operations that do not require skilled technical personnel.

The present invention is a method of assisting the detection of NASH, which includes: a) measuring the amount of LDL-TG contained in a test blood sample isolated from a living body; b) measuring the amount of at least one component selected from the group consisting of LDL-C, LDL subfraction-C, IIDL-C, HDL subfraction-C, ApoB, ApoE, total cholesterol, ALT, and AST contained in the test blood sample; and c) determining the possibility of developing and/or having NASH by using the amount of LDL-TG in combination with the amount of the at least one component.

The present disclosure provides methods of treating subjects having a liver disease with a CAMP Responsive Element Binding Protein 3 Like 3 (CREB3L3) inhibitor, and methods of identifying subjects having an increased risk of developing a liver disease.

A method of diagnosis and treatment of primary biliary cholangitis is provided. Additionally, a pharmaceutical composition and a solid dosage form for the treatment of primary biliary cholangitis, containing ursodeoxycholic and obeticholic acids, are provided. The technical contribution resides in obtaining a new all-purpose pharmaceutical composition and solid dosage form for the treatment of PBC, which includes both ursodeoxycholic and obeticholic acids, which is effective in use at all stages of PBC and has a complex mechanism of action. In particular, simultaneous blockage of the transport and synthesis of bile acids is achieved.