Methods for the detection, enumeration and analysis of circulating tumor cells expressing insulin-like growth factor-1 receptors (IGF-1R) are disclosed. These methods are useful for cancer screening and staging, development of treatment regimens, and for monitoring for treatment responses, cancer recurrence or the like. Test kits that facilitate the detection, enumeration and analysis of such circulating tumor cells are also provided.

This invention provides modified IGFBP-derived peptides—collectively termed “immodulator peptides”—and related compositions and methods. Chemical modifications to peptides using small molecules, and sequence extensions to immodulator core sequences exhibit new and surprising biological activities. The invention builds the combinatorial power of the immodulator peptide class further by demonstrating which core sequences bind metal or glycosaminoglycans such as heparin. The invention discloses some surprising biological properties of compositions derived from these modifications, including a host of new therapeutic and diagnostic utilities (e.g. immune modulation of TLR signaling, enhanced collagen synthesis by skin fibroblasts, and synergy with a RIG-1 agonist in killing melanoma cells). The invention also teaches methods for enhancing previously disclosed uses of immodulator peptides by showing how the modifications of the invention can boost the efficacy of immodulator peptides in a model of burn trauma.

The present invention relates to methods and compositions for monitoring, diagnosis, prognosis, and determination of treatment regimens in subjects suffering from or suspected of having a renal injury. In particular, the invention relates to using a measured urine concentration of one or more of TIMP2 and IGFBP7 in combination with one or more of a measured serum creatinine and a measured urine output, which results are correlated to the renal status of the subject, and can be used for diagnosis, prognosis, risk stratification, staging, monitoring, categorizing and determination of further diagnosis and treatment regimens in subjects suffering or at risk of suffering from an injury to renal function, reduced renal function, and/or acute renal failure.

The present invention relates to a method for diagnosing a recent paroxysmal atrial fibrillation. The method is based on the determination of the at least one marker selected from the group consisting of a cardiac Troponin, NT-proBNP (N-terminal prohormone of brain natriuretic peptide), hsCRP, IL-6 (Interleukin-6) and IGFBP7 (Insulin like growth factor binding protein 7) in a sample from the subject, and on the comparison of the, thus, determined amount(s) with a reference amount (reference amounts). Further, the present invention relates to a method for identifying a subject being treatable with anticoagulation therapy. Further envisaged are systems, reagents and kits used in performing the methods disclosed herein.

The present invention relates to methods and compositions for monitoring, diagnosis, prognosis, and determination of treatment regimens in subjects suffering from or suspected of having a renal injury. In particular, the invention relates to using a one or more assays configured to detect a kidney injury marker selected from the group consisting of Coagulation factor VII, CA 19-9, Insulin-like growth factor-binding protein 7, C—X—C motif chemokine 6, and C—C motif chemokine 13 as diagnostic and prognostic biomarkers in renal injuries.

The present invention relates to a method for diagnosing a respiratory tract infection in a subject, comprising determining in a sample from said subject the level of High-Mobility-Group-Protein B1 (HMGB1), and/or determining in a sample from said subject the level of a histone protein, and/or determining in a sample from said subject the level of Insulin-like growth factor binding protein, acid labile subunit (IGFALS), wherein the subject is diagnosed with a bacterial respiratory tract infection when the level of IGFALS is below a predetermined threshold level and/or the level of the histone protein is above a predetermined threshold value, and/or wherein the subject is diagnosed with a respiratory tract infection when the level of HMGB1 is above a predetermined threshold level.

The invention provides IGFBP7 immunoassays with improved clinical performance, particularly when used in the evaluation of renal injuries. The immunoassays rely on the selection and use of antibodies and antibody pairs that exhibit improved assay performance when used in complex clinical specimens such as biological fluids, and particularly when used in rapid assay formats such as lateral flow test devices.

Some embodiments are directed to a method for the in vitro detection/prediction of imminent childbirth based on the detection of at least two of the following markers: insulin-like growth factor-binding protein 1 (IGFBP-1), a N-terminal fragment of insulin-like growth factor-binding protein 1, and interleukin 6 (IL-6). Some embodiments are also directed to a device for the implementations of the method. Some embodiments are applicable in the medical field, in the diagnostic field, and in particular in the obstetric field.

It is an object of the present invention to provide methods for assessing the efficacy of a remote ischemic preconditioning procedure though the measurement of urinary TIMP-2 and IGFBP7 concentrations.

The present invention relates to a method for identifying a subject being eligible to the administration of at least one medicament selected from the group consisting of a beta blocker, an aldosterone antagonist, a diuretic, and an inhibitor of the renin-angiotensin system. The method is based on the determination of the amount of at least one biomarker selected from the group consisting of GDF-15 (Growth Differentiation Factor 15), endostatin, mimecan, IGFBP7 (IGF binding protein 7), a cardiac Troponin, a BNP-type peptide, uric acid, Gal3 (Galectin-3), osteopontin, sST2 (soluble ST2), PlGF, sFlt-1, P1NP, Cystatin C, Prealbumin, and Transferrin in a sample from a subject suffering from heart failure. Further, the method comprises the step of comparing the, thus, determined amount with a reference amount. Further envisaged by the present invention are kits and devices adapted to carry out the method of the present invention. The present invention also relates to a system for identifying a subject being eligible to the administration of at least one medicament as disclosed herein and to reagents and kits used in performing the methods as disclosed herein.