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 assays that detect one or more of Metalloproteinase inhibitor 1, Metalloproteinase inhibitor 2, Metalloproteinase inhibitor 4, C—C motif chemokine 15, C—C motif chemokine 18, C—C motif chemokine 23, and/or, C—C motif chemokine 24 as diagnostic and prognostic biomarker assays in renal injuries.

This disclosure generally relates to a molecular classification of cancer and particularly to molecular markers for predicting response to cancer therapy, including cancer immune therapy, and methods of use thereof.

A method of classifying the severity of a coronaviral infection of a subject is disclosed. The method comprises measuring the TRAIL and/or IP10 protein level in a body liquid sample of the subject, wherein the level is indicative of the severity of the coronaviral infection. Managing treatments for coronaviral infections are also disclosed as well as measuring contagiousness of infections.

The present invention discloses a method for diagnosing cancer comprising a step of detecting active protein kinase Cα in urine.

The present invention relates to extracellular microvesicles biomarkers for determining the tumour transformation status or presence of a tumour in a subject, and to the uses of such biomarkers and to diagnostics methods using such biomarkers. In particular, the methods and uses of the invention involve isolation of TM9SF4-positive extracellular vesicles and detection of the expression of a second biomarker, preferably selected from the group consisting of CD9 protein, miR-21 and RNU6.

Methods of using T cell frequency (TCFR) in melanoma, e.g., as determined by high throughput DNA sequencing of the TCRB gene, as a predictor of disease progression and survival in patients with primary melanoma, and to select and treat subjects.

Described herein are Dirofilarial exhalant signatures and methods of detecting a Dirofilaria signature in a non-blood biological sample, such as exhalant, that can be used to detect Dirofilarial infection in a subject, such as a canine.

The present invention provides methods for using surgical drainage waste fluid as a means for diagnosing disease, assessing disease progression, predicting metastatic disease, assessing cancer metastasis, disease staging, molecular staging, and assessing metastatic disease. During surgery, suction is used to drain fluids such as blood, tissue fluids, and other bodily fluids away from the surgery site. The suction drainage fluid waste, also called drain fluid, is removed from the patient during the surgical procedure. Because surgical drain fluid is typically viewed as something that is not useful, it is disregarded and thrown away during the surgery. Instead, the invention provides that drain fluid, which is mostly lymphatic fluid and interstitial fluid, is diagnostically rich and contains important information for assessing, diagnosing, and treating disease. The methods of the invention use this waste fluid for the valuable data it contains. Therefore, while a patient is already undergoing surgery for a medical condition, the waste drain fluid is sampled and analyzed for biomarkers or other molecular indicia of disease.

Described herein is fatty acid-binding protein 3 (FABP3) and/or FABP4 for diagnosing or staging peripheral artery disease (PAD) or for assessing revascularization in PAD afflicted subjects. Also described is FABP3 and/or FABP4 for distinguishing PAD patients from non-PAD patients regardless of the presence PAD symptoms, for distinguishing PAD patients with a non-compressible ABI from non-PAD patients, or for determining prognosis in PAD. Also described herein are various methods and biomarker panels for use in PAD.

The present invention relates to agents and methods for treating gastrointestinal cancer (e.g., metastatic colorectal cancer) in a subject in need thereof. The method includes suppressing the enzymatic activity of DHODH and/or decreasing the level of creatine via suppression of creatine transporter channel SLC6a8 in the subject. In some embodiments, the suppression step can be carried out by administering to the subject a set of small molecule compounds.