Abstract: The present invention relates to the field of reproduction (e.g., human reproduction). In particular, the present invention provides markers (e.g., pentraxin 3 and Annexin A6), and methods of using the same to determine oocyte development potential. The present invention also provides compositions and methods for modifying oocyte development potential and assays (e.g., using markers of the present invention) for detecting gene expression associated with oocyte development potential. Such compositions and methods find use in diagnostic, research and therapeutic applications.

Abstract: The present invention relates to methods of diagnosing and predicting organ transplant rejection. In particular, the present invention relates to the detection and prediction of kidney transplant rejection by detection of CXCR3 and CCL chemokines in urine. The present invention provides improved methods of diagnosing organ rejection and determining the efficacy of anti-rejection drugs.

Abstract: Integrin-linked kinase (ILK) and Akt/protein kinase B (PKB) are important mediators of signaling in cardiomyocytes and can both prevent damage and promote healing associated with ischemic injury to the heart. Thus, the present invention provides for methods of screening for agents that increase the expression of ILK and/or Akt/PKB. Methods of treatment based on such agents are also provided.

Abstract: Compositions containing bacteriophages and methods of using bacteriophages in microorganism detection assays and microbial growth and plating media are disclosed. The lytic ability of these phages to control the growth of non-target populations provides superior sensitivity and specificity to detection assays and reduces false negative and false positive results. The removal of contaminating bacteria reduces the microbial competition for nutrients in the growth media thereby increasing the efficiency and productivity of the culture. The phage treatment of the sample increases the proportion of target microorganisms in the sample over contaminating bacteria thereby requiring less time for enrichment to obtain a significant signal improving overall signal to noise ratio in assays and providing for higher yield of end product in microbiological production systems.

Abstract: This invention relates to a method of diagnosing or treating a biological subject, such as a person or animal, comprising the steps of subjecting at least a microsample of the subject's tissue to a physiological perturbation and measuring the response of the microsample to the perturbation using optical coherence tomography (OCT). In an exemplary embodiment, the concentration of glucose in the microsample is perturbed, as by providing the subject with a high glucose drink, and subsequently monitoring at a high sample rate in a microsample by OCT. Pathology, such as diabetes, can be diagnosed by deviation of the concentration vs. time response over several cells (micro-oscillation) from the micro-oscillation in the cells of a healthy subject. Other applications include diagnosing or treating de-hydration and diseases that cause changes in the osmolyte concentrations and thus the osmotic pressure in the cells in tissue.

Abstract: A system for generating an image of ultrastructural biomarkers from a biological sample is provided. The system includes a grid onto which a sample to be imaged may be placed and a cryogenic reservoir into which the grid and sample may be immersed for vitrification of the sample. The system also includes a stage onto which the grid and sample may be situated for subsequent imaging in a high contrast imager to permit identification of ultrastructural biomarkers therein. A method for generating an image of ultrastructural biomarkers from a biological sample is also provided. The generated image of ultrastructural biomarkers may be used subsequently for screening and monitoring diseases, evaluating drug and therapeutic efficacy, and assessing risks associated with a drug or therapeutic candidate, among other things.

Abstract: The present invention provides a method of testing for the presence of infectious disease agents or host genetic markers comprising applying a device comprising an absorbent and porous material onto the introitus of a female patient; encouraging air drying of at least a portion of the collected vaginal discharge while the device is proximate to the introitus; and determining the presence of infectious disease agents or host genetic markers in the at least partially dried vaginal discharge.

Abstract: A method for diagnosing pregnancy-related complications in a pregnant woman. The method comprises (a) providing PP13-responding cells having a membrane; (b) exposing the cells to standard PP13; (c) exposing PP13-responding cells to PP13 obtained from the woman, and (d) determining the existence of a modification in the permeability of the cell membrane in (b) and in (c) as a result of exposure to PP13. The modification in permeability in (b) and (c) is then compared, a change in the permeability of (c) as compared to the permeability in (b) indicating the existence of a pregnancy complication in the woman.

Abstract: An in vivo assay to measure anchorage-independent growth and phenotypic stability of a certain cell population comprising subcutaneous or intramuscular injection in a mammal of a cell suspension of articular chondrocytes in an iso-osmotic liquid, the same suspension comprising articular chondrocytes in an amount equivalent to at least 1×106 chondrocytes as applied to immune-deficient mice. The outcome is linked to molecular markers. The present invention further relates to DNA chips and diagnostic tools comprising the latter to predict the outcome of ACT. Antibodies raised against positive and negative markers of chondrocyte stability can also be used for quality control on the chondrocytes. Therapeutical compositions comprising stable chondrocytes are very useful for tissue repair.

Abstract: A method for analyzing the identity, protein and/or peptide pattern and also the stability of samples containing physiologically acceptable enzyme mixtures with lipolytic, proteolytic and amylolytic activity, particularly mixtures of digestive enzymes such as pancreatin, for use in manufacturing medicinal products comprising such enzyme mixtures, e.g. precipitated pancreatin or pancreatin mini-microspheres.

Abstract: An in vivo assay to measure anchorage-independent growth and phenotypic stability of a certain cell population comprising subcutaneous or intramuscular injection in a mammal of a cell suspension of articular chondrocytes in an iso-osmotic liquid, the same suspension comprising articular chondrocytes in an amount equivalent to at least 1×106 chondrocytes as applied to immune-deficient mice. The outcome is linked to molecular markers. The present invention further relates to DNA chips and diagnostic tools comprising the latter to predict the outcome of ACT. Antibodies raised against positive and negative markers of chondrocyte stability can also be used for quality control on the chondrocytes. Therapeutical composition comprising stable chondrocytes are very useful for tissue repair.

Abstract: The present invention relates to methods of diagnosing, predicting and monitoring kidney disorders. In particular, the present invention relates to the diagnosis, prediction and monitoring of kidney disorders by detection of cytokines, cytokine-related compounds and chemokines in urine. The present invention further relates to methods and compositions for assessing the efficacy of agents and interventions used to treat kidney disorders.

Abstract: The present invention is generally related to products and methods permitting the identification of Enterobacter species organisms. In addition, the invention provides the capability to differentiate Enterobacter infections from other acute bacterial infections.

Abstract: A system and method for high throughput patch clamp measurements to study the effect of various chemicals on ion transfer channels is provided. One or more patch clamp configurations is established, each comprising a cell sealed to a pipette. The pipettes are affixed to a pipette fixture. The pipette fixture and a plate comprising one or more wells are relatively moved so that each cell is inside a well. Electrical properties of the cells are measured.

Abstract: The present invention relates a method for the enumeration of mammalian cell micronuclei, while distinguishing micronuclei from the chromatin of dead and dying cells. The method utilizes differential staining of chromatin from dead and dying cells, to distinguish the chromatin from micronuclei and nuclei that can be detected based upon fluorescent emission and light scatter following exposure to an excitatory light source. Counting of micronuclei events relative to the number of nuclei can be used to assess the DNA-damaging potential of a chemical agent, the DNA-damaging potential of a physical agent, the effects of an agent which can modify endogenously-induced DNA damage, and the effects of an agent which can modify exogenously-induced DNA damage. Kits for practicing the invention are also disclosed.

Abstract: The invention provides an in vivo screening assay and an in vitro screening assay for rapid screening of diabetes. A method of the invention includes determining a first glucose concentration in an ocular fluid of a patient; administering orally a load of carbohydrate to the patient; determining a second glucose concentration in an ocular fluid of the patient at a period of time of less than 50 minutes after orally administering of the load of carbohydrate; comparing the second glucose concentration with the first glucose concentration to determine if the patient is likely to be a diabetic. The method of the invention is performed by using a kit of the invention. The kit comprises: (1) a glucose-sensing ophthalmic device and instructions for using the glucose-sensing ophthalmic device to screen for diabetes; or (2) two or more tear-collecting devices, and a testing agent composition which specifically reacts with glucose to form a detectable signal.

Abstract: A system for rapidly determining the presence or quantity of coliform bacteria in a water sample using the enzymes ?-D-galactosidase and ?-D-glucuronidase. The system includes a first filter means for separating bacteria from the sample and a broth for culturing the bacteria including an inducing agent for inducing enzyme production. A second filter means is used to separate the cultured bacteria from the broth. A lysing agent is exposed to the bacteria on the second filter and incubated with a chemiluminogenic substrate of the enzyme to produce a chemiluminescent product. Light emission is initiated from the second filter means and the emitted light is detected or measured directly from the second filter means using a luminometer adapted to receive the second filter means.

Abstract: The invention provides methods of detecting bacteria in fluids, including blood, platelets and other blood products for transfusion, and urine. The methods are based on lysing the bacteria to release ATP and detecting the ATP. Eukaryotic cell contamination is a problem to be overcome, because eukaryotic cell contain large amounts of ATP. Thus, some of the methods involve separating intact eukaryotic cells (e.g., platelets) from intact bacterial cells before lysing the bacterial cells to release ATP, contacting the ATP with an ATP-consuming enzyme that catalyzes a reaction, and monitoring the enzyme-catalyzed reaction. Typically, the enzyme is luciferin, and the reaction is monitored by detecting light produced by the luciferin. Other methods of the invention involve contacting a fluid sample with a support surface that binds bacterial cells, lysing the bacterial cells to release ATP, contacting the ATP with an ATP-consuming enzyme, and monitoring the enzyme-catalyzed reaction.

Abstract: The present invention relates to compositions and methods for identifying abnormalities in TSC signaling pathways. In particular, the present invention relates to methods of diagnosing and treating disorders such as tuberous sclerosis, which are caused by mutations in the TSC genes. The present invention further relates to methods and compositions for treating cancers mediated by TSC signaling disorders.

Abstract: The present invention concerns the use of hepcidin as a marker for detecting inflammatory chronic diseases and especially for a differential diagnosis to detect inflammatory chronic diseases and/or non-inflammatory chronic diseases. The present invention also concerns a method for detecting inflammatory chronic diseases, non-inflammatory chronic diseases and/or acute phase reactions comprising the determination of hepcidin.