The invention relates to diagnosis, detection, screening, identifying and predicting methods. In various embodiments, methods of the invention include diagnosis, detection, or screening for a hyperproliferative disorder (e.g., a tumor, cancer or neoplasia) in the subject; identifying a subject that will or is likely to respond to a therapy for a hyperproliferative disorder (e.g., a tumor, cancer or neoplasia); and predicting therapeutic efficacy of a hyperproliferative disorder (e.g., a tumor, cancer or neoplasia) treatment in a subject.

The methods of the present invention include noninvasive methods for the isolation of antibody-producing cells from the gut and the use of the cells so-isolated to generate antibodies responsive to biomarkers for a number of health conditions. The responsive antibodies are chimeric secretory antibodies comprising IgA and IgG moieties that may be useful in the diagnosis and treatment of various health conditions after challenged with biomarkers thereof. In a preferred embodiment, stool samples may be obtained from patients suffering from HIV infection and cells may be isolated from the samples according to the methods described herein and reacted with antibodies responsive to HIV biomarkers. The diagnostic methods described herein allow for room temperature sample isolation for up to five days prior to diagnosis and are useful in detecting latent HIV that cannot be detected in blood samples. It is another object of the invention to generate therapeutic antibodies.

It is disclosed herein that that certain alkylphosphocholine analogs are preferentially taken up by malignant pediatric tumor cells. The alkylphophocholine analogs are compounds having the formula: ##STR00001##
or salts thereof, wherein n is an integer from 12 to 24; and R.sub.2 is —N.sup.+(CH.sub.3).sub.3. The compounds can be used to treat pediatric solid tumors or to detect pediatric solid tumors. In therapeutic treatment, R.sub.1 includes a radioactive iodine isotope that locally delivers therapeutic dosages of radiation to the malignant pediatric tumor cells that preferentially take up the compound. In detection/imaging applications, R.sub.1 includes a detection moiety, such as a fluorophore or a radioactive iodine isotope.

An assay device for use with samples of biological fluid, the assay device comprising: a physical detection unit for measuring a viscosity of a biological fluid sample; and a biomarker detection unit for detecting and/or measuring a biomarker in the biological fluid sample, wherein the physical detection unit and the biomarker detection unit act together as part of an assay process.

Provided is a non-invasive method of detecting or screening for a cancer in a subject specimen originating in a tissue outside of the lung. The method includes detecting elevated levels of one or more carbonyl-containing volatile organic compounds (VOCs) that are biomarkers for the cancer in exhaled breath from the subject specimen. The method may further include obtaining exhaled breath from the subject specimen; forming adducts of the carbonyl-containing VOCs with a reactive chemical compound; quantifying the adducts of the carbonyl-containing VOCs to establish a subject value for each of the adducts; and comparing each subject value to a threshold healthy specimen value for each of the adducts of the carbonyl-containing VOCs. One or more subject values at quantities greater than threshold healthy specimen values are also useful for screening for the cancer in the subject specimen.

The present invention provides a cancer stem cell elimination agent containing a substance that suppresses an expression or function of SDC4, a method for detecting or sorting a cancer stem cell in a cancer cell population, including using an expression of SDC4 as an index, and the like.

Provided are a polypeptide and nucleic acid for encoding the polypeptide, a nucleic-acid construct, an expression vector, and a host cell containing the nucleic acid, an antigen-presenting cell presenting the polypeptide on the surface of the cell, and immune effector cell thereof, a pharmaceutical composition containing the polypeptide, a vaccine containing the nucleic acid, the nucleic acid construct, the expression vector, the host cell, the antigen-presenting cell, and the immune effector cell, and an antibody recognizing the polypeptide. Also provided is a therapeutic method using the polypeptide, the nucleic acid, the pharmaceutical composition, the vaccine, and the antibody. Also provided are a diagnosis method and diagnosis apparatus for detecting the described polypeptide. Also provided is an application of the polypeptide in preparing a vaccine, a tumor diagnosis kit, or a pharmaceutical composition, and an application of the polypeptide or the nucleic acid as a test target in tumor diagnosis.

The present invention relates to peptides, proteins, nucleic acids and cells for use in immunotherapeutic methods. In particular, the present invention relates to the immunotherapy of cancer. The present invention furthermore relates to tumor-associated T-cell peptide epitopes, alone or in combination with other tumor-associated peptides that can for example serve as active pharmaceutical ingredients of vaccine compositions that stimulate anti-tumor immune responses, or to stimulate T cells ex vivo and transfer into patients. Peptides bound to molecules of the major histocompatibility complex (MHC), or peptides as such, can also be targets of antibodies, soluble T-cell receptors, and other binding molecules.

A reliable assay to specifically detect CD155 in tissue sections has widespread use because CD155 is expressed widely among tumor types. Additionally, detected expression of CD 155 in glioblastoma cells is at levels commensurate with susceptibility to PVSRIPO (a poliovirus construct) infection and killing. An anti-CD155 antibody can achieve mono-specific detection of CD155 in immunoblots of tumor homogenates and immunohistochemistry of tumor formalin fixed, paraffin embedded sections. The assay can be used to determine appropriate use of PVSRIPO in oncolytic immunotherapy against cancers.

The disclosure provides methods of treating a tumor/cancer by administering naltrexone or an analogue thereof, followed by a recovery phase, and then administering a small molecule signaling inhibitor such as PI3-kinase inhibitors, AKT inhibitors, taxanes, antimetabolites, alkylating agents and/or cell cycle inhibitors. The disclosure also provides diagnostic methods for assessing a therapeutic response to the methods of treatment.