The invention provides biomarkers and combinations of biomarkers useful in diagnosing lung diseases such as non-small cell lung cancer or reactive airway disease. The invention also provides methods of differentiating lung disease, methods of monitoring therapy, and methods of predicting a subject's response to therapeutic intervention based on the extent of expression of the biomarkers and combinations of biomarkers. Kits comprising agents for detecting the biomarkers and combination of biomarkers are also provided.

Disclosed herein are certain sets of antibody-fluorophore pairs comprising antibodies that specifically bind target antigens, the sets of antibody-fluorophore pairs thereby allowing visualization and quantification of a plurality of target antigens in a biological sample using multispectral tissue slide scanners. Also disclosed herein are methods of using such antibody-fluorophore pairs, and reagents related thereto.

The present invention relates to methods and kits to assess an absorbed dose of ionizing radiation and/or the severity of tissue injury from radiation in a patient. The invention also relates to algorithms used to calculate an absorbed dose of radiation based on biomarker measurements of a plurality of biomarkers that are altered relative to a normal control in the event of radiation exposure.

Reagents and methods to use said reagents for detection of markers of various aspects of Lyme disease have been identified in biological fluids thus permitting diagnosis or classification of Lyme disease subjects as well as indicating suitable methods of treatment.

This disclosure describes markers that are associated with active tuberculosis (TB) and demonstrates that the disclosed markers can be used as a biomarker for determining whether a subject has or is at risk of having active TB and for the early detection of HIV-associated TB. This disclosure also provides methods of screening subjects who are thought to be at risk for developing active TB, methods of determining the efficacy of therapeutic regimens for preventing or treating active TB, and methods of identifying anti-TB agents.

Compositions and methods for predicting due date and time to birth for a pregnancy with significantly higher accuracy than current clinical methods. The compositions and methods for predicting due date and time to birth for a pregnancy can also identify those pregnancies that will deliver earlier than the due date derived from Last Menstrual Period (LMP) and/or obstetric ultrasonography (US) dating.

A biomarker panel for a urine test for detecting lung cancer detects a biomarker selected from the group of biomarkers consisting of DMA, C5:1, C10:1, ADMA, C5-OH, SDMA, and kynurenine, or a combination thereof. A biomarker panel for a serum test for detecting lung cancer detects a biomarker selected from the group of biomarkers consisting of valine, arginine, ornithine, methionine, spermidine, spermine, diacetylspermine, C10:2, PC aa C32:2, PC ae C36:0, and PC ae C44:5; and lysoPC a C18:2, or a combination thereof.

Provided herein are biomarkers and methods for generating scores useful for assessing psoriatic arthritis (PsA) disease activity in subjects previously diagnosed with PsA. The invention also provides predictive model methods based on the biomarkers, as well as computer systems, software embodiments of the models for scoring and optionally classifying samples, and methods of recommending optimal therapeutic regimens.

A method of diagnosis and treatment of primary biliary cholangitis is provided. Additionally, a pharmaceutical composition and a solid dosage form for the treatment of primary biliary cholangitis, containing ursodeoxycholic and obeticholic acids, are provided. The technical contribution resides in obtaining a new all-purpose pharmaceutical composition and solid dosage form for the treatment of PBC, which includes both ursodeoxycholic and obeticholic acids, which is effective in use at all stages of PBC and has a complex mechanism of action. In particular, simultaneous blockage of the transport and synthesis of bile acids is achieved.

The invention provides a method for determining a systemic lupus erythematosus-associated disease state in a subject comprising the steps of (a) providing a sample to be tested; and (b) measuring the presence and/or amount in the test sample of one or more biomarker(s) selected from the group defined in Table A, wherein the presence and/or amount in the test sample of the one or more biomarker(s) selected from the group defined in Table A is indicative of a systemic lupus. The invention also provides an array and a kit suitable for use in the methods of the invention.