A method for diagnosing or treating a mammalian subject having, or at risk of developing cancer, comprising: generating a circulating anti-cancer CD4.sup.+ Th1 response from antigen presenting cells or their precursors and CD4.sup.+ T-cells from a sample of said subject's blood which causes secretion of interferon-gamma (“IFN-γ”); and detecting said anti-cancer CD4.sup.+ Th1 response to determine if said response is depressed. A method for restoring HER2-specific CD4.sup.+ Th1 immune response in a HER2-positive breast cancer patient in need thereof, comprising: administering to said patient a therapeutically effective amount of a dendritic cell (“DC”) vaccine comprising autologous DCs pulsed with HER2-derived MHC class II binding peptides (“DC vaccination”) to elevate said patient's anti-HER2 CD4.sup.+ Th1 response, and measuring said anti-HER2 Th1 response of said patient pre- and post-DC vaccination to determine the amount of increase in said response.

A kit is disclosed for distinguishing between bacterial and viral infections. One of the antibodies of the kit specifically binds to TNF-related apoptosis-inducing ligand (TRAIL) protein and another of the antibodies of the kit specifically binds to Procalcitonin (PCT) protein.

The invention provides therapeutic compositions that present an artificial repertoire of mammalian pattern recognition receptor (PRR) agonists, so that the pattern of PRR agonists recapitulates a distinct portion of a PRR agonist signature of a mammalian pathogen. The artificial repertoire of PRR agonists may be formulated together in a therapeutic vehicle for combined presentation to an innate immune cell resident in a target tissue in a mammalian host, and the vehicle adapted to deliver the PRR agonists to the target tissue, so as to modulate an immune response.

Provided are a method for diagnosing cancer, a diagnosis kit and compositions useful for measurement of NK cell activity. The incidence of cancer may be diagnosed by monitoring changes in the in vivo immune system through measurement of NK cell activity in blood. Thus, the incidence of cancer may be readily predicted as described herein using a blood sample from a subject.

The present invention includes a composition and a method of modulating an immune response with a composition that comprises an anti-BAFF receptor antibody or binding fragment thereof that is bound or conjugated to an siRNA, and shRNA, or both, that targets a BAFF receptor mRNA.

Provided herein are compositions and methods of using Seneca Valley Virus (SW), or a derivative thereof, combined with an IFN-I inhibitor for treating a cancer in a subject. The disclosed methods particularly rely upon the expression level of an ANTXR1 and the expression level of IFN-I in the cancer from the subject. Also provided herein are methods for predicting the efficacy of an SW treatment and a kit for determining the same.

The present inventors identified a subpopulation of genes induced by type I and type II IFNs in a human submandibular gland (HSG) epithelial cell line. Unexpectedly, it was found that the majority of genes that are highly up-regulated by IFN-α are also highly induced by IFN-γ. In contrast, there was a substantial group of genes that are highly induced by IFN-γ only. In target tissues, this identified subpopulation of genes and probes allow different IFN patterns to be discerned, enabling more precise molecular classification of patient subpopulations. The identified gene probes are useful for selecting and monitoring therapy, and for defining efficacy of novel agents in the autoimmune rheumatic diseases.

Systems, methods, compositions, and kits for measuring secreted factors from cells are disclosed herein, including those capable of determining single cell secretion activity and protein expression and/or gene expression simultaneously. Disclosed herein include solid supports comprising a plurality of capture probes capable of specifically binding to at least one of the plurality of secreted factors secreted by a single cell. Also disclosed herein include secreted factor-binding reagents capable of specifically binding to a secreted factor bound by a capture probe. A secreted factor-binding reagent can comprise a secreted factor-binding reagent specific oligonucleotide comprising a unique factor identifier sequence for the secreted factor-binding reagent.

Methods for detecting the presence of sever acute respiratory coronavirus 2 (SARS-CoV-2) are provided. The methods comprise incubating a sample comprising T-cells from an individual with one or more SARS-CoV-2 antigens, each antigen having a T-cell epitope, and detecting a change in state of T-cells in the sample. The change in state may be detected by determining the presence or level of a secreted, immune response indicator, such as interferon-gamma (IFN-γ).

The present invention generally relates to pharmacokinetic and pharmacodynamics markers for cancer therapeutic regimens and methods of treating cancer. Oncolytic virus probes that comprise a nucleic acid encoding soluble interferon beta (IFNβ) and methods for use thereof are provided.