Abstract: The invention relates to biomarkers associated with Diabetes, including protein and lipid metabolite biomarkers, methods of using the biomarkers to determine the risk that an individual will develop Diabetes, and methods of screening a population to identify persons at risk for developing Diabetes and other pre-diabetic conditions.

Abstract: This invention relates to methods for assessing quantities of spherical or substantially spherical lipoprotein particles or portions thereof present in a biological sample based on the measurement of free cholesterol and/or phospholipid content in the lipoprotein particles. The invention also relates to the use of the assessed quantities of the lipoprotein particles or portions thereof to determine whether a subject is at increased risk for cardiovascular diseases and cardiodiabetes.

Abstract: Disclosed are methods of identifying subjects with arteriovascular disease, subjects at risk for developing arteriovascular disease, methods of differentially diagnosing diseases associated with arteriovascular disease from other diseases or within sub-classifications of arteriovascular disease, methods of evaluating the risk of arteriovascular events in patients with arteriovascular disease, methods of evaluating the effectiveness of treatments in subjects with arteriovascular disease, and methods of selecting therapies for treating arteriovascular disease.

Abstract: The invention describes biomarkers which can be used to predict the likelihood that an individual will develop Diabetes. The biomarkers can also be used to screen large groups in order to identify individuals at risk of developing Diabetes.

Abstract: The invention relates to, among other things, a method for performing electrophoresis with in-situ calibration. The method includes combining a volume of a test sample with a volume or quantity of a calibrating sample to form a final volume, where the volume of the calibrating sample includes a known concentration of a calibrator and the final volume includes a known ratio of test sample to calibrating sample. The method also includes depositing a loading fraction in a receiving well of an electrophoretic gel, in which the loading fraction is a fraction of the final volume, and separating the loading fraction along a common separation lane of the electrophoretic gel such that components of the test sample and the calibrator are separated from one another along the common separation lane.

Abstract: A nucleic acid purification device includes a housing and an adapter operatively attached to the housing. The adapter is configured to receive at least one well plate which includes a plurality of wells for receiving contents including at least a sample and a plurality of paramagnetic particles. The device also includes a motor disposed within the housing and configured to selectively move at least the adapter to thereby disrupt or shake the contents of the plurality of wells when the at least one well plate is received by the adapter. The device further includes at least one electromagnetic feature configured to selectively receive an electrical signal and thereby magnetize at least a portion of the plurality of paramagnetic particles when the plurality of paramagnetic particles are received by the plurality of wells and the at least one well plate is received by the adapter.

Abstract: A washing device includes a top compartment capable of receiving a manifold dispenser. The manifold dispenser is coupled to a rack and comprises at least one liquid input and a plurality of liquid outputs that operably direct fluid to contact a plurality of laboratory consumables held by the rack. A middle compartment is attached to the top compartment and comprises a washing chamber capable of receiving fluid output by the plurality of liquid outputs of the manifold dispenser. The washing chamber has a floor comprising a material transparent to ultraviolet (UV) light. A bottom compartment is attached to the washing chamber. The cottom compartment includes a light source mounted thereto. The light source is capable of outputting UV light in the direction of the washing chamber and through the floor of the washing chamber. A method of washing laboratory consumables is also disclosed.

Abstract: A method for generating a report presenting a patient-specific information relevant to assessing a patient's cardiodiabetes risk to guide and allow a physician or healthcare provider in the choice of therapy or therapies that will be maximally effective for a specific patient, to monitor the response to the chosen therapy and reduce the patient's risk of developing cardiodiabetes and/or its complications.

Abstract: A method for analyzing genomic DNA includes introducing a plurality of samples comprising human cells into individual vessels in each of a plurality of multi-vessel well plates. At least a subset of the human cells in the plurality of samples is lysed without the use of heat. DNA in the at least a subset of lysed human cells is isolated with the use of a plurality of paramagnetic beads. The isolated DNA is analyzed to identify one or more single nucleotide polymorphisms (SNPs), wherein the lysing, isolating, and analyzing steps are performed substantially in parallel for each of the plurality of samples.

Abstract: The invention provides methods and compositions for diagnosing prior ischemic stroke or transient ischemic attack (TIA) and approximate the time said stroke occurred, comprising measurement of IgG and IgM antibodies to NR2A and/or NR2B NMDA receptor or fragment thereof in a biological sample, and comparing those measurements to reference population standards and to each other. The invention also includes optionally measuring other biomarkers for autoimmune disease for the reduction in false positives and better risk stratification for future stroke events. The method is particularly useful for identifying individuals that are at risk for future stroke or TIA, and for diagnosing previous history of ischemic stroke or TIA. This measurement and comparison enables determination of the risk of future stroke which is by definition higher in those patients who have suffered a previous stroke.

Abstract: This application relates to methods of predicting susceptibility or likelihood of a clinically-relevant mannose-binding lectin (MBL)-deficient subject to develop a cardiovascular disease and/or cardiodiabetes. The methods include measuring MBL mass or concentration and, optionally, measuring MBL activity, at least one other biomarker and/or genotyping of MBL gene and its promoters; combining the information obtained into a calculated MBL-inclusive index score that involves mathematical transformation; and assigning a risk of cardiadiabetic status and clinical endpoints based on the determination and comparison of the MBL inclusive index to reference values from a population.

Abstract: The present invention relates to, among other things, a gel electrophoresis system for detecting the level of specific Apolipoproteins and/or lipoprotein particles present in intact lipid particles in a biological sample. The system includes a gel substrate to receive a biological sample, at least two lipoprotein-binding complexes. Each complex includes an antibody that binds a lipoprotein particle or a portion thereof, which is bound to a signal producing molecule capable of producing or causing production of a detectable signal. The system also includes a device for detecting the detectable signal. The present invention also relates to methods of assessing the level of specific Apolipoproteins and/or lipoprotein particles present in a biological sample, determining whether a subject is at increased risk for cardiovascular disease, and monitoring the risk for developing cardiovascular disease.

Abstract: This invention relates to a method for detecting the presence of or likelihood of a patient of developing occult pancreatic beta cell dysfunction, and a method for detecting the presence of or likelihood of a patient of developing clinically significant post-prandial hyperglycemia. The methods involve (a) measuring a level of alpha-hydroxybutyrate (AHB) in a single fasting baseline biological sample of the patient; (b) comparing the level of AHB in the single fasting baseline biological sample to a reference AHB level; and (c) determining the presence of or likelihood of developing the disorder in the patient based on the comparison in step (b). An increased AHB level at fasting baseline indicates that a normoglycemic, normo-insulinemic and/or non-dyslipidemic patient has developed or has an increased likelihood of developing occult pancreatic beta cell dysfunction.

Abstract: This invention relates to a method for detecting the presence of or likelihood of a patient of developing occult pancreatic beta cell dysfunction, and a method for detecting the presence of or likelihood of a patient of developing clinically significant post-prandial hyperglycemia. The methods involve (a) measuring a level of alpha-hydroxybutyrate (AHB) in a single fasting baseline biological sample of the patient; (b) comparing the level of AHB in the single fasting baseline biological sample to a reference AHB level; and (c) determining the presence of or likelihood of developing the disorder in the patient based on the comparison in step (b). An increased AHB level at fasting baseline indicates that a normoglycemic, normo-insulinemic and/or non-dyslipidemic patient has developed or has an increased likelihood of developing occult pancreatic beta cell dysfunction.

Abstract: A lab rack rotator includes a motor coupled to a shaft arranged to rotate in at least one direction in response to the motor. One or more mounts are located along the surface of the shaft and are configured to receive a lab sample rack which holds a plurality of lab samples contained in lab sample containers such as test tubes. Rotation of the shaft permits inversion of the plurality of lab samples, for instance whole blood samples. The lab rack rotator increases the number of lab samples that may be agitated in an automated process while decreasing the amount of time required for necessary pre-testing agitation of samples.

Abstract: An application module configured to provide a historical graph report which plots a patient's diagnostic test result values over time, in which the historical graph is included in a customizable laboratory report. The historical graph is configured to show a patient or physician of any identifiable changes or trends that the patient has experienced with regard to his/her diagnostic test result values for one or more identified biomarkers. The application module may utilize unique graphical objects within the graph itself or with respect to individual cells in the chart to indicate the particular risk level that a corresponding test result value may be assigned to.

Abstract: This invention relates to a rapid, high-throughput process for analyzing one or more sterols/stanols or derivatives thereof in a plurality of samples. The method comprises the steps of introducing a plurality of samples containing one or more sterols/stanols or derivatives thereof into individual vessels in a multi-vessel plate; cleaving the one or more sterols/stanols or derivatives thereof of each sample in the multi-vessel plate to form free sterols/stanols; extracting the free sterols/stanols of each sample by solid phase extraction; and detecting the level of the extracted free sterols/stanols in each sample by liquid chromatography tandem mass spectrometry. In this process, the free sterols/stanols do not undergo an additional derivitization step of adding a functional group to the free sterols/stanols prior to the detecting step.

Abstract: The invention provides compositions and methods for determining patient compliance with a smoking cessation program, and monitoring the patient for physiological recovery from the deleterious effects of smoking, with particular emphasis on those effects that impact risk of cardiovascular disease and development of cancer. The invention also provides compositions and methods for treating a subject according to the patient compliance with the smoking cessation program.

Abstract: This invention relates to an apparatus and a process for rapid, high-throughput analysis of fatty acids in a plurality of samples. The apparatus comprises at least one multi-vessel plate, wherein each vessel is a unit for holding a sample, or mixing and/or reacting a sample with one or more solvents or reagents; at least one matching multi-cap mat capable of sealing the vessels of the multi-vessel plate during the holding, mixing and/or reacting the sample; at least one multi-vessel plate holder having sealing units, whereby the multi-vessel plate holder, when the sealing units are engaged, presses the matching multi-cap mat onto the tops of the vessels in the multi-vessel plate sealing the vessels, so as to withstand high pressure and high temperature conditions. The process employs the apparatus that enables automated, high-throughput analysis of twenty-four fatty acid from a plurality of samples by gas chromatography flame ionization detection.