The invention provides for the early detection, diagnostic, and prognostic assays and assay kits for breast cancer and other cancers, based upon the detection of human endogenous retroviruses (HERVs) as cancer biomarkers.

Methods for detecting and/or measuring the level of sodium-dependent multivitamin transporter (SMVT) in a biological sample. The methods include the steps of: (a) contacting the biological sample with a PERV-B.RBD ligand, a variant and/or a fragment thereof; and, detecting and/or measuring the binding of the PERV-B.RBD ligand, variant and/or fragment thereof to SMVT.

The present invention provides methods of detecting analytes using particles having different physico-chemical properties, such as buoyancy, size, density, spectral characteristics, and/or binding properties, in solution-based sandwich assays and solution-based competition assays. The methods can be performed using rotors and bench-top centrifuges and provide for rapid, qualitative and quantitative detection of analytes. The present invention also provides kits that can be used to perform the methods, and mixtures containing particles suitable for the methods.

The present invention relates to a method of quantifying the amount of Mock Virus Particles (MVP) removed from a solution as a result of processing that solution through a purification technique. This method involves the steps of adding MVP to a solution, processing the solution through a purification technique, quantifying the amount of MVP removed from the solution. The present invention also relates to a kit that can be used in conjunction with the method. This kit will comprise at least one stock solution of MVP and at least one quantification solution.

The present invention relates to a stock solution (RLP Stock Solution) of mammalian cell-endogenous retrovirus like particles (RLP), a method of preparing a RLP stock solution, a kit containing a RLP stock solution, and a method of quantifying the amount of RLP removed from a solution. An RLP stock solution will contain a high concentration of RLP and an extremely low amount of any therapeutic proteins of interest. In some instances, an RLP stock solution will contain a very low amount of natural mammalian host cell protein (HCP) and DNA. The method of preparing a RLP stock solution will consist of the production of RLP during fermentation or cell culturing and the subsequent purification of RLP from fermentation or cell culture solution. The kit will comprise at least two containers. One container comprised of RLP stock solution and one comprised of PCR primers or one or more antibodies. The method of quantifying RLP comprises the steps of adding RLP stock solution to an in-process solution containing a recombinant therapeutic of interest, processing the resulting solution through a bioprocess purification technique, and then quantifying the amount of RLP removed.

The present invention relates to a novel antibody against HERV-K envelope that targets a conserved region not affected by glycosylation or by native conformation, and its use in diagnostics and/or is therapy.

The present invention relates to a method for assessing susceptibility of a virus to treatment with a drug inhibiting an enzyme of the wild-type virus comprising the steps: a) extracting the viral enzyme from a sample containing the virus; b) measuring the viral enzyme activity both in the absence of the drug and in the presence of the drug at a single predetermined concentration; and c) determining the virus' susceptibility to treatment with the drug from the relation between the enzyme activities in the presence of the drug and the absence of the drug. The invention further relates to a system for performing the method.

Disclosed are methods of treating a patient exposed to MTV. Also disclosed is a purified cDNA encoding an MTV transition protein peptide chain. Also disclosed is a vaccine containing an MTV transition protein. A further version of the invention is a vaccine comprising MTV polypeptides coupled to a carrier protein. MTV may be treated by providing an MTV vaccine with an MTV transition protein; and, administering said vaccine. In further instances, the MTV vaccine is administered with an antiretroviral medication.

A fully integrated sample-in-signal-out microfluidic paper-based analytical devices are provided relying on bioluminescence resonance energy transfer (BRET) switches for target analyte recognition and colorimetric signal generation. Simultaneous colorimetric detection and quantification of multiple antibodies in a single drop of whole blood is shown. The devices make use of BRET-based antibody sensing proteins integrated into vertically assembled layers of functionalized porous layer(s) of material. The device enables sample volume independent, eliminates addition of reagents to the sample, and has on-device blood plasma separation. User operation is a single drop of a sample and the acquisition of a photograph after sample introduction, with no requirement for precise pipetting, liquid handling or analytical equipment except for a camera. Using different antibodies as targets, simultaneous detection in whole blood was achieved. This device is believed to be ideally suited for user-friendly point-of-care-testing in low-resource environments based on BRET-sensors.

An object of the present invention is to provide a technique for preventing or treating HTLV-1-associated diseases, such as ATL, a material for use in the technique, a method for screening the material, and the like. The present invention provides a TCR screening method comprising sorting HTLV-1-derived antigen-recognizing cells from cells derived from an HTVL-1 patient and subjecting the HTLV-1-derived antigen-recognizing cells to TCR repertoire analysis, ranking the TCR types in descending order of the number of cells of each TCR type, and selecting a highly ranked TCR. The present invention provides a prophylactic or therapeutic agent for an HTLV-1-associated disease, the agent comprising a TCR comprising specific CDRs that can be obtained by the TCR screening method and cells expressing the TCR.