Disclosed herein are methods that aid in the determination of whether a subject has a traumatic brain injury (TBI) by detecting levels of at least one biomarker, glial fibrillary acidic protein (GFAP), in samples taken from a subject, such as a human subject, where the subject has received a head CT scan that is negative for a TBI.

Embodiments of the disclosure are directed to biomarkers, or a panel of biomarkers, that determine progression of Alzheimer's disease, and methods of use thereof.

The invention relates to an in vitro method for isolating nucleic acids associated to or contained inside extracellular vesicles (EVs) from a sample based on the formation of a DMB-EVs precipitate and the isolation of the nucleic acids present in the precipitate. The invention also relates to the use of the method of the invention for diagnosing or for determining the susceptibility of a subject to a disease, for determining the prognosis or for monitoring the progression of a disease, for monitoring the effect of a therapy, for identifying compounds suitable for the treatment of a disease, or for designing a personalized therapy or selecting a patient susceptible to being treated with a therapy for the prevention and/or treatment of a disease. In addition, the invention also relates to a kit comprising dimethylmethylene blue (DMB) and a reagent capable of isolating nucleic acids from EVs, and to its use.

Provided herein are methods for determining the functional status of G-protein coupled receptor (GPCR) signaling pathways in a diseased cell sample obtained from a subject to thereby select for therapeutic use in the subject a RAS node or receptor tyrosine kinase (RTK) targeted therapeutic. Also provided are methods for determining whether a GPCR signaling pathway is ultrasensitive in a diseased cell sample from a subject. Methods of administering a selected RAS node or RTK targeted therapeutic agent to the subject are also provided.

The invention relates to methods of cardiovascular imaging and/or measurement of blood markers for detecting, diagnosing and/or prognosing cardiac or myocardial microbleeds, especially in subject with hypertension and cardiovascular diseases. Treatment methods are also provided for subjects identified, diagnosed, prognosed, or detected with cardiac or myocardial microbleeds. In some embodiments, the subject has hypertension-induced microbleeds, but has not had a myocardial infarction or reperfusion therapy.

The invention relates to a collection of signature peptides representing at least 10 proteins for use in cancer diagnosis and/or prognosis, to an artificial protein comprising signature peptides representing at least 10 proteins and to a nucleic acid construct encoding for such an artificial protein. The invention further relates to a collection of at least 10 proteins for use in cancer diagnosis and/or prognosis. Additionally, the invention relates to a method for cancer diagnosis and/or prognosis comprising the step of analyzing at least 10 proteins in a urine sample of a subject. Finally, the invention relates to an immunoassay product comprising antibodies for detecting at least 10 proteins.

Methods are provided for the prognosis, diagnosis and treatment of various pathological states, including cancer, chemotherapy resistance and dementia associated with Alzheimer's disease. The methods provided herein are based on the discovery that various proteins with a high level of sialylation are shown herein to be associated with disease states, such as, cancer, chemotherapy resistance and dementia associated with Alzheimer's disease. Such methods provide a lysosomal exocytosis activity profile comprising one or more values representing lysosomal exocytosis activity. Also provided herein, is the discovery that low lysosomal sialidase activity is associated with various pathological states. Thus, the methods also provide a lysosomal sialidase activity profile, comprising one or more values representing lysosomal sialidase activity. A lysosomal sialidase activity profile is one example of a lysosomal exocytosis activity profile.

The invention provides methods for determining tumour status in a subject comprising the steps of: (i) determining a quantitative value in a sample taken from a subject of a first biomarker selected from the group consisting of Ran, Ran binding protein 1, an active fragment of a Ran protein, a nucleic acid sequence encoding Ran, a nucleic acid sequence encoding Ran binding protein 1, a nucleic acid sequence encoding an active fragment of Ran and a nucleic acid sequence encoding an active fragment of Ran binding protein 1; (ii) comparing the quantitative value of the first biomarker in the sample with a selected pre-determined threshold value of the first biomarker; (iii) determining a quantitative value in a sample from the same subject of a second biomarker selected from the group consisting of MMP2, an active fragment of MMP2, a nucleic acid sequence encoding MMP2 and a nucleic acid sequence encoding an active fragment of MMP2; (iv) comparing the quantitative value of the second biomarker in the sample with a selected pre-determined threshold value of the second biomarker; wherein the quantitative values of the first marker and the second biomarkers in the sample as compared to their respective selected pre-determined threshold values indicate whether or not the tumour sample has invasive and/or metastatic potential.

Methods and reagents for diagnosing, prognosing, and treating systemic lupus erythematosus (SLE) are disclosed, involving calculating an SLE risk score for a subject based on a level of each of an erythrocyte C4d (EC4d) marker, a B-cell C4d (BC4d) marker, antinuclear antibodies (ANA), anti-Smith antibodies (anti-Sm) and optional rule-out markers (SS-B/La, Scl-70, Jo-1, CENP, MCV).

Disclosed are methods relating to the use of circular PCMTD1 as a diagnostic and prognostic marker for leukemias and cancers with a p53 mutation and/or BCR/ABL fusions. Additionally, disclosed herein are oligonucleotides and antibodies that can be used to identify the circular PCMTD1 for use in the diagnostic and prognostic methods and target the circular PCMTD1 in treatment methods.