Featured are biornarkers for, e.g., diagnosis and prognosis of spinal muscular atrophy (SMA) as well as identification of responders to treatment of SMA. Also provided are methods of treating subjects with SMA.

A method for determining the concentration of lactulose in a blood sample comprises the steps of converting lactulose in the blood sample into an entity including galactose, and converting the galactose into D-galacto-hexodialdose and hydrogen peroxide, which is detected. The detected quantity is processed to generate an output which is representative of the concentration of lactulose in the blood sample.

The present disclosure relates to a method of treating a disease or disorder associated with an abnormality in CNS function. Also provided is a method for diagnosing and/or identifying a subject having an abnormality in CNS function. FAM19A1 antagonists that can be used with the present disclosures are also provided.

The present invention is in the field of transactive response DNA binding protein with a molecular weight of 43 kDa (TARDB or also TDP-43). The invention relates to TDP-43 specific binding molecules, in particular to anti-TDP-43 antibodies or an antigen-binding fragment or a derivative thereof and uses thereof. The present invention provides means and methods to diagnose, prevent, alleviate and/or treat a disease, disorder and/or abnormality associated with TDP-43 aggregates including but not limited to Frontotemporal dementia (FTD), amyotrophic lateral sclerosis (ALS), Alzheimer's disease (AD), Parkinson's disease (PD), Chronic Traumatic Encelopathy (CTE), and limbic-predominant age-related TDP-43 encephalopathy (LATE).

This invention provides methods of detecting biomarkers in the biofluid of sepsis-associated encephalopathy (SAE) patients, including but not limited to glial fibrillary acidic protein (GFAP), ubiquitin C-terminal hydrolase LI, Tan protein, Neurofilament light chain (NF-L), myelin basic protein (MBP), secretogranin, Copeptin, total all-spectrin, all-spectrin breakdown products (SBDP, including SBDP145, SBDP150, SBDP120 all-spectrin N-terminal fragment or SBDP150N), neuron specific enolase (NSE), mature brain derived neurotrophic factor (BDNF), and full-length Pro-BDNF. These biomarker peptides are markers of axonal and blood brain barrier integrity which can be used to diagnose SAE and to assess and predict cognitive performance and outcomes in acute presentations of sepsis.

Disclosed herein are antibodies or antigen-binding fragments thereof and compositions comprising the same. Also disclosed are methods of detecting TAR DNA-binding protein 43 (TDP-43) in a biological sample, diagnosing a neurodegenerative disease in a subject, and selecting whether to enroll a subject in a clinical trial for frontotemporal lobar degeneration with TDP-43 inclusions (FTLD-TDP) using the antibodies or antigen-binding fragments thereof described herein. In addition, disclosed herein are immunoassay kits for selectively detecting TDP-43 in a biological sample.

The present invention relates to biomarkers and diagnostic and prognostic methods for Alzheimer's disease and other neurodegenerative disorders. The invention also provides compositions for detecting the biomarker as well as compositions and methods useful for treating Alzheimer's disease and other neurodegenerative disorders.

The present invention provides methods, compositions, and kits for the detection of Early-Stage Alzheimer's disease (AD) autoantibody biomarkers, for the diagnosis of Early-Stage AD, for the identification of a subject at risk for developing Early-Stage AD, and/or for the generation of patient-specific Early-Stage AD autoantibody biomarker profiles.

The present disclosure provides antibodies that specifically bind to human FAM19A5 and compositions comprising such antibodies. Also provided herein are methods for treating fibrosis or cancer using the anti-FAM19A5 antibodies.

Monoclonal anti-PHF-tau antibodies and antigen-binding fragments thereof are described. Also described are nucleic acids encoding the antibodies, compositions comprising the antibodies, methods of producing the antibodies and using the antibodies for treating or preventing conditions such as tauopathies.