Disclosed herein are methods, kits, tests, and systems for detecting, predicting, monitoring, or ruling out preeclampsia in pregnant women. Also provided herein are novel diagnostic markers, methods of data analysis, assay formats, and kits employing such markers to improve one or more characteristics of a test for identifying or ruling out preeclampsia based on biomarkers from patient samples.

The present invention relates to a method for prediction of response to cardiovascular regeneration comprising the use of biomarkers. Further, the present invention relates to a combination of the biomarkers for use in a method for prediction of response to cardiovascular regeneration, a computer device to perform a method according to the present invention and a device adapted for carrying out the inventive method.

The invention is an ex vivo method for early detection of acute kidney injury in critical patients, which includes the measurements of fibroblast growth factor 23 (FGF23), klotho (KL) and erythropoietin (EPO) as biomarkers. These measurements are obtained from a venous blood sample or urine, and allow the determination of the following indicators: 1=([FGF23]p×[EPO]p); 2=([FGF23]p/[Klotho]p); 3=([EPO]p)/[Klotho]p); 4=([FGF23]p×[EPO]p)/[Klotho]p); where [X]p is defined as the plasma level of a specific molecule (X) which includes fibroblast growth factor 23 (FGF23), klotho (KL) or erythropoietin (EPO). If the value of the indicator 1, 2, 3, 4 or two or more thereof, is equal or higher than a cut-off point (10 U), the indicator and/or indicators allow the identification of patients with high risk of developing AKI, with a high sensitivity/specificity. Therefore high levels of the indicator are associated to a high probability of the presence/development of AKI, which allows to perform specific clinical interventions for patients with AKI. If the value of the indicator 1, 2, 3, 4 or two or more thereof, is lower than the previously mentioned cut-off point, the probability of presence/development of AKI is low, therefore patients require only standard treatment.

The present invention directs to a method for treating a smooth muscle cell proliferative disease by using a recombinant expression vector comprising a polynucleotide encoding FGF12, or by using FGF12 protein or a fragment thereof; and a method for detecting a marker for diagnosis of smooth muscle cell proliferative disease, comprising the measurement of FGF12 expression level.

Biomarkers are provided that predict whether a human subject having a renal cell carcinoma is responsive to a combination therapy comprising lenvatinib or a pharmaceutically acceptable salt thereof (e.g., lenvatinib mesylate) and everolimus. The biomarkers, compositions, and methods described herein are useful in selecting appropriate treatment modalities for and treating a subject having, suspected of having, or at risk of developing a renal cell carcinoma.

The present invention relates to a method for assessing whether a subject shall be subjected to an imaging based diagnostic assessment. The method is based on the determination of the amount(s) of a cardiac Troponin and/or Fibroblast Growth Factor 23 (FGF-23) in a sample from the subject, and on the comparison of the, thus, determined amount(s) with a reference amount (reference amounts). The present invention also relates to a system for performing an assessment whether a subject shall be subjected to an imaging based diagnostic assessment and to reagents and kits used in performing the methods disclosed herein. Moreover, the present invention is directed to a method for predicting the risk of mortality and/or of a cardiovascular event. Also encompassed is a method for diagnosing an early stage of LVH in a subject having a preserved left ventricular ejection.

The invention concerns uses of anti-KLβ agents, and detection of KLβ and/or FGF19 and/or FGFR4.

Disclosed is a two-staged, generalized cancer screening concept modeled closely after a suppression test. The test is blood based, and screens for elevated levels of Fibroblast Growth Factor 19 (FGF19), a cancer biomarker expressed across a majority of cancers, via standard enzyme-linked immunosorbent assay (ELISA). Unlike other biomarker-based blood tests that rely on a single-blood draw, the F-CME test validates cancer with a follow-up test using oral cholestyramine as the “suppression” drug.

The present application relates to: a composition for diagnosing a Helicobacter pylori-associated disease, the composition comprising a preparation for measuring the expression amount of a gene whose expression is increased or decreased by Helicobacter pylori infection; and a use thereof.

Biomarkers are provided that predict whether a subject having a hepatocellular carcinoma is responsive to a therapy comprising soratenib or a pharmaceutically acceptable salt thereof. The biomarkers, compositions, and methods described herein are useful in selecting appropriate treatment modalities for and treating a subject having, suspected of having, or at risk of developing a hepatocellular carcinoma.