Abstract: The invention provides for malignancy-risk gene signatures that predict the risk of developing breast cancer, the recurrence of breast cancer, and/or the metastasis of breast cancer. These signatures have numerous clinical applications including assessing risk of breast cancer development following routine breast biopsy, assessing the need for adjuvant radiotherapy after lumpectomy, and determining the need for completion mastectomy following lumpectomy for the breast cancer patient and other treatment plans that are personalized for the patient.

Abstract: An embodiment of the present invention relates to a system for the integrated and automated analysis of DNA or protein, including a single-use cartridge, an analysis device comprising a control device, and devices for capturing and processing signals. An embodiment of the present invention relates, in particular, to the control device for carrying out a completely automatic process and evaluation of molecular diagnostic analysis via single-use cartridges (Lab-on-a-Chip). The first devices are provided for controlling an analysis process which occurs in the cartridge, subsequently the displacement and the thermostatisation of liquids, and the second devices are provided for processing the signals which are obtained during the analysis. The first and the second devices are synchronized in such a manner that the analysis process of the sample can be carried out in a totally integrated manner thus producing an immediate result.

Abstract: Described are devices and methods for detecting binding on an electrode surface. In addition, devices and methods for electrochemically synthesizing polymers and devices and methods for synthesizing and detecting binding to the polymer on a common integrated device surface are described.

Abstract: A microfluidic device for a confocal fluorescence detection system has an input channel defined by a body of the microfluidic device, a sample concentration section defined by the body of the microfluidic device and in fluid connection with the input channel, a mixing section defined by the body of the microfluidic device and in fluid connection with the concentration section, and a detection region that is at least partially transparent to illumination light of the confocal fluorescence detection system and at least partially transparent to fluorescent light when emitted from a sample under observation as the sample flows through the detection region.

Abstract: Provided are methods and devices for single-molecule genomic analysis. In one embodiment, the methods entail processing a double-stranded nucleic acid and characterizing said nucleic acid. These methods are useful in, e.g., determining structural variations and copy number variations between individuals.

Abstract: The invention relates to the field of biosensors and, more specifically, to nanoparticle biosensors comprising: a magnetic core, a silica layer, one or more outer metal layers which can be of different types and deposited in an alternating manner and immobilized on the outer surface, and a layer of synthetic or natural organic or inorganic biosensor molecules that can bind to biomolecules. The invention also relates to a method of obtaining the nanoparticle biosensors as well as to the different uses thereof.

Abstract: An Accelerated Progression Relapse Test (APRT) is provided for use in the prognosis of a diseased state in a patient. The APRT provides a determination of when a patient in a particular diseased state is likely to benefit from further disease treatment, or does not have a high probability of benefit with additional treatment. In particular applications, the APRT may be used to determine the prognosis of an estrogen receptor positive (ER+) breast cancer patient. Four genetic probes are disclosed for this test, and target MK167, CDC6 and SPAG5 gene products. The ER+ breast cancer patient/patient population is stratified into two groups, with the low gene expression group identifying the patient/patient group that is less likely to benefit from additional treatment measures, and a high gene expression group identifying the patient/patient group as more likely to benefit from additional treatment measures.

Abstract: Described are quality control methods and devices for the reproducible manufacturing and integrity monitoring of polymers on electrochemical synthesis and detection chips. The devices and methods allow for simultaneous manufacturing and synthesis of polymers.

Abstract: Methods and devices for the interfacing of microchips to various types of modules are disclosed. The technology disclosed can be used as sample preparation and analysis systems for various applications, such as DNA sequencing and genotyping, proteomics, pathogen detection, diagnostics and biodefense.

Abstract: The invention generally provides three-component molecular biosensors. The molecular biosensors are useful in several methods including in the identification and quantification of target molecules.

Abstract: Methods and devices for the interfacing of microchips to various types of modules are disclosed. The technology disclosed can be used as sample preparation and analysis systems for various applications, such as DNA sequencing and genotyping, proteomics, pathogen detection, diagnostics and biodefense.

Abstract: Provided are improved processes and apparatuses for solid phase oligonucleotide synthesis, the improvements comprising carrying out detritylation of the nascent oligonucleotide using a composition of an organic solvent, a protic solvent and a selected concentration, or selected concentration range, of water. In some embodiments, an oligonucleotide synthesis apparatus includes means for adding water to a detritylation reagent. In some embodiments, an apparatus can include a water detector for analyzing the water concentration of a detritylation reagent to be reacted with a nascent oligonucleotide. An apparatus can comprise a feedback loop to control the concentration of water at the point of the detritylation reaction and/or to control the detritylation reaction time. The apparatuses and methods reduce batch-to-batch variations in the manufacture of oligonucleotides immobilized on the surface of various substrates.

Abstract: The invention provides human polymorphisms that are associated with Parkinson's disease (PD). Also disclosed are compositions and methods for use in diagnostics, prognostics, prevention, treatment and/or study of PD.

Abstract: Described are devices and methods for detecting binding on an electrode surface. In addition, devices and methods for electrochemically synthesizing polymers and devices and methods for synthesizing and detecting binding to the polymer on a common integrated device surface are described.

Abstract: Sequence-specific nucleic acid hybridization assays are used for the detection of specific genetic sequences as indicators of genetic anomalies, mutations, and disease propensity. In addition, they are used for the detection of various biological agents and infectious pathogens. Because a complementary probe or nucleic acid sequence is required to detect a sequence of interest in a hybridization-based assay, nucleic acid sequencing techniques can rapidly determine the specific probe sequence being used for detection. This allows reverse engineered assays to be produced rapidly. In addition, it enables the circumvention of hybridization-based assays for biological agent or infectious pathogen detection by providing the information necessary to create or alter nucleic acid sequences to produce false positives or false negatives. The present invention provides methods and compositions for inhibiting the identification of specific detection sequences.

Abstract: The invention provides a probe for detecting a target polynucleotide. The probe contains a region that base-pairs with a target polynucleotide to form a duplex and a RNA hairpin extension domain that increases the stability of the duplex. The probe may further include a nucleotide clamp, a stem-complementary region and/or a linker moiety. Also provided is an array of subject probes bound to a surface of a solid support. Methods of using a subject probe to assess target polynucleotides, e.g., small RNAs, in a sample are provided, as are kits for use in practicing the subject methods.

Abstract: A DNA comprising a 609 bp base sequence from ?559 to +50 when the first base sequence of exon 1 of the midkine gene, a human retinoic acid-responsive growth/differentiation factor was set as +1, or a DNA comprising a 251 bp base sequence from ?213 to +38 when the transcription initiation point of the c-erbB-2 gene belonging to the EGF receptor family and having a tyrosine kinase activity was set as +1 has a tumor-specific transcription activity, and the promoter activity thereof is high, and therefore is very important as a tumor-specific promoter for use in the suicide gene therapy that combines the use of a gene for a drug metabolizing enzyme and a prodrug for cancer therapy, the gene therapy of cancer using an expression vector that contains a gene encoding a cytokine, and the gene therapy of cancer using an oncolytic virus.

Abstract: This invention discloses a gene-targeted non-human mammal and generational offspring with respect to the gene encoding a mutant protein product of a mutated presenilin 1 gene (PS-1); more specifically, a gene-targeted mouse with respect to the gene sequence encoding the mutant protein product of PS-1 which has been mutated to contain the human P264L mutation. Methods for screening chemical compounds using such mammals are also disclosed.

Abstract: Disclosed are various compositions for use in the delivery of nucleic acid to a target cell including: a composition comprising a calcium salt in particulate form, the nucleic acid to be delivered, and one or more further components to enhance the efficiency of delivery of the nucleic acid to a target cell, the nucleic acid and the one or more further components being complexed with the particulate calcium salt; and methods of delivering a nucleic acid to a target cell.

Abstract: Intestinal epithelial cells of a mammalian subject are genetically altered to operatively incorporate a gene which expresses a protein which has a desired effect. The method of the invention comprises administration of a formulation containing DNA to the gastrointestinal tract, preferably by an oral route. The expressed recombinant protein is secreted directly into the bloodstream. Of particular interest is the use of the method of the invention to provide for short term delivery of gene products to the bloodstream.