公开(公告)号：US09696276B2

公开(公告)日：2017-07-04

申请号：US13896765

申请日：2013-05-17

Applicant: Boston Heart Diagnostics Corporation

Inventor： Bela F. Asztalos ,  Ernst J. Schaefer

IPC: G01N33/53 ,  G01N27/447 ,  C12M1/26

CPC classification number: G01N33/561 ,  C12M33/00 ,  G01N27/44739 ,  G01N27/44747 ,  G01N27/44778 ,  G01N33/54386 ,  G01N33/6842 ,  G01N33/92 ,  G01N2333/775 ,  G01N2550/00 ,  G01N2800/32 ,  G01N2800/50 ,  G01N2800/52

Abstract: Disclosed are methods and apparatus for separation of biomolecules via two-dimensional gel electrophoresis, methods and apparatus for immunoblotting separated biomolecules, and methods for the use of biomolecules processed via the methods and apparatus of the present invention, including use in a clinical setting. The methods and apparatus for separation of biomolecules via two-dimensional gel comprises vertical agarose gel electrophoresis in the first dimension, and the electrophoresis of a novel non-denaturing 3-35% concave gradient polyacrylamide gel in the second dimension. This novel gel can be cast in a modified gel caster that can facilitate the pouring of multiple gels simultaneously. The methods and apparatus for immunoblotting are useful with any type of immunoblotting, including Western blot, Northern blot, and Southern blot analyzes. These methods and apparatus provide safe, efficient and cost-effective immunoblots, while facilitating the reduction of exposure to toxic or radioactive materials, as well as the disposal of those materials.

公开(公告)号：US20140235607A1

公开(公告)日：2014-08-21

申请号：US14265862

申请日：2014-04-30

Applicant: Boston Heart Diagnostics Corporation

Inventor： Ernst J. Schaefer ,  Eliana Polisecki

IPC: A61K31/22 ,  C12Q1/68 ,  A61K31/397

CPC classification number: C12Q1/6883 ,  A61K31/22 ,  A61K31/397 ,  C12Q1/6827 ,  C12Q2600/106 ,  C12Q2600/156 ,  C12Q2600/172

Abstract: The invention pertains to a method of determining a statin dosage for an individual in need of treatment with a statin, comprising determining a SLCO1B1 genotype from a nucleic acid sample of the individual, said genotype comprising the presence or absence of the SLCO1B1-056 polymorphism, and determining an ApoE genotype or phenotype identifying an ApoE polymorphism selected from the group consisting of ApoE2, ApoE3, ApoE4, and any combination thereof, wherein the combination of a SLCO1B1 genotype identifying the presence of the SLCO1B1-056 C polymorphism and the ApoE genotype or phenotype identifying one of the ApoE3/4 or ApoE4/4 genotypes indicates the statin dosage.

Abstract translation: 本发明涉及一种确定需要用他汀类药物治疗的个体的他汀类药物剂量的方法，包括从个体的核酸样品确定SLCO1B1基因型，所述基因型包括存在或不存在SLCO1B1-056多态性， 以及确定鉴定选自ApoE2，ApoE3，ApoE4及其任何组合的ApoE多态性的ApoE基因型或表型，其中鉴定SLCO1B1-056C多态性存在的SLCO1B1基因型与ApoE基因型的组合或 识别ApoE3 / 4或ApoE4 / 4基因型之一的表型表明他汀类药物的剂量。

公开(公告)号：US09817001B2

公开(公告)日：2017-11-14

申请号：US13945436

申请日：2013-07-18

Applicant: Boston Heart Diagnostics Corporation

Inventor： Bela F. Asztalos ,  Ernst J. Schaefer

IPC: G01N33/92

CPC classification number: G01N33/92 ,  G01N2800/52

Abstract: Disclosed is a personalized diagnostic and treatment solution for cardiovascular disease. The invention comprises methods for devising a personalized treatment plan for a patient via the use of an extended CVD risk assessment panel measuring markers of cholesterol absorption and production and HDL subfractions. This solution provides a more complete risk assessment of an individual than merely measuring traditional CVD risk markers alone, and enables the healthcare practitioner to optimize therapy for patients with or without established CVD. This solution presents the advantages of greater accuracy, savings in time and cost over existing testing and treatment methods.

公开(公告)号：US09828624B2

公开(公告)日：2017-11-28

申请号：US13949847

申请日：2013-07-24

Applicant: Boston Heart Diagnostics Corporation

Inventor： Ernst J. Schaefer

IPC: C12Q1/60 ,  G01N33/92 ,  G01N33/50 ,  A61K31/366 ,  A61K31/40 ,  A61K31/397

CPC classification number: C12Q1/60 ,  A61K31/366 ,  A61K31/397 ,  A61K31/40 ,  G01N33/5008 ,  G01N33/92

Abstract: Methods of the invention involve determining a patient's compliance with a cholesterol lowering therapy. In certain aspects, the invention provides methods that involve conducting a first assay to determine a cholesterol biomarker level in a first sample from a patient prior to the patient undergoing a cholesterol lowering therapy. The methods may also involve conducting a second assay to determine a cholesterol level in a second sample obtained from the patient after the patient has started undergoing a cholesterol lowering therapy. Additionally, the methods involve associating the cholesterol level and the cholesterol biomarker level in which the association allows for the determination of the patient's compliance with the cholesterol lowering therapy.

公开(公告)号：US08765377B2

公开(公告)日：2014-07-01

申请号：US13650948

申请日：2012-10-12

Applicant: Ernst J. Schaefer ,  Eliana Polisecki

Inventor： Ernst J. Schaefer ,  Eliana Polisecki

IPC: C12Q1/68 ,  C12Q1/60

CPC classification number: C12Q1/6883 ,  A61K31/22 ,  A61K31/397 ,  C12Q1/6827 ,  C12Q2600/106 ,  C12Q2600/156 ,  C12Q2600/172

Abstract: The invention pertains to a method of determining a statin dosage for an individual in need of treatment with a statin, comprising determining a SLCO1B1 genotype from a nucleic acid sample of the individual, said genotype comprising the presence or absence of the SLCO1B1-056 polymorphism, and determining an ApoE genotype or phenotype identifying an ApoE polymorphism selected from the group consisting of ApoE2, ApoE3, ApoE4, and any combination thereof, wherein the combination of a SLCO1B1 genotype identifying the presence of the SLCO1B1-056 C polymorphism and the ApoE genotype or phenotype identifying one of the ApoE3/4 or ApoE4/4 genotypes indicates the statin dosage.

Abstract translation: 本发明涉及一种确定需要用他汀类药物治疗的个体的他汀类药物剂量的方法，包括从个体的核酸样品确定SLCO1B1基因型，所述基因型包括存在或不存在SLCO1B1-056多态性， 以及确定鉴定选自ApoE2，ApoE3，ApoE4及其任何组合的ApoE多态性的ApoE基因型或表型，其中鉴定SLCO1B1-056C多态性存在的SLCO1B1基因型与ApoE基因型的组合或 识别ApoE3 / 4或ApoE4 / 4基因型之一的表型表明他汀类药物的剂量。

公开(公告)号：US20140120559A1

公开(公告)日：2014-05-01

申请号：US13662113

申请日：2012-10-26

Applicant: Boston Heart Diagnostics Corporation

Inventor： Ernst J. Schaefer

IPC: G01N33/566 ,  G01N27/26 ,  G01N30/02 ,  G01N33/53 ,  G01N33/66

CPC classification number: G01N33/6893 ,  G01N33/66 ,  G01N33/74 ,  G01N33/92 ,  G01N2333/765 ,  G01N2405/02 ,  G01N2800/042 ,  G01N2800/50

Abstract: The present invention generally relates to predicting the risk of developing diabetes in patients who currently do not have diabetes. The invention can involve obtaining a sample from a patient negative for diabetes, conducting an assay on the sample to obtain a level of a glycated albumin, and determining an elevated risk of developing a diabetic condition if the level exceeds a predetermined threshold.

Abstract translation: 本发明一般涉及预测目前不具有糖尿病的患者发生糖尿病的风险。 本发明可以涉及从糖尿病阴性的患者获得样品，对样品进行测定以获得糖化白蛋白的水平，并且如果水平超过预定阈值，则确定发展糖尿病状态的风险升高。

公开(公告)号：US20140088073A1

公开(公告)日：2014-03-27

申请号：US13950732

申请日：2013-07-25

Applicant: Boston Heart Diagnostics Corporation

Inventor： Ernst J. Schaefer

IPC: A61K31/397

CPC classification number: A61K31/397 ,  A61K31/366 ,  A61K31/40 ,  C12Q1/60 ,  G01N33/502 ,  G01N33/92 ,  A61K2300/00

Abstract: The invention generally relates to methods for determining whether a patient should be administered a drug that inhibits cholesterol absorption. In certain aspects, methods of the invention involve obtaining a sample from a patient, conducting an assay on the sample to obtain a level of a cholesterol absorption marker, and comparing the level to a reference level, in which a level above the reference level indicates that the patient should be administered a drug that inhibits cholesterol absorption.

Abstract translation: 本发明一般涉及用于确定患者是否应给予抑制胆固醇吸收的药物的方法。 在某些方面，本发明的方法包括从患者获得样品，对样品进行测定以获得胆固醇吸收标记的水平，并将该水平与参考水平进行比较，其中高于参考水平的水平表明 应该给予患者抑制胆固醇吸收的药物。

公开(公告)号：US09198890B2

公开(公告)日：2015-12-01

申请号：US14265862

申请日：2014-04-30

Applicant: Boston Heart Diagnostics Corporation

Inventor： Ernst J. Schaefer ,  Eliana Polisecki

IPC: C12Q1/68 ,  C12Q1/60 ,  A61K31/22 ,  A61K31/397

CPC classification number: C12Q1/6883 ,  A61K31/22 ,  A61K31/397 ,  C12Q1/6827 ,  C12Q2600/106 ,  C12Q2600/156 ,  C12Q2600/172

Abstract: The invention pertains to a method of determining a statin dosage for an individual in need of treatment with a statin, comprising determining a SLCO1B1 genotype from a nucleic acid sample of the individual, said genotype comprising the presence or absence of the SLCO1B1-056 polymorphism, and determining an ApoE genotype or phenotype identifying an ApoE polymorphism selected from the group consisting of ApoE2, ApoE3, ApoE4, and any combination thereof, wherein the combination of a SLCO1B1 genotype identifying the presence of the SLCO1B1-056 C polymorphism and the ApoE genotype or phenotype identifying one of the ApoE3/4 or ApoE4/4 genotypes indicates the statin dosage.

Abstract translation: 本发明涉及一种确定需要用他汀类药物治疗的个体的他汀类药物剂量的方法，包括从个体的核酸样品确定SLCO1B1基因型，所述基因型包括存在或不存在SLCO1B1-056多态性， 以及确定鉴定选自ApoE2，ApoE3，ApoE4及其任何组合的ApoE多态性的ApoE基因型或表型，其中鉴定SLCO1B1-056C多态性存在的SLCO1B1基因型与ApoE基因型的组合或 识别ApoE3 / 4或ApoE4 / 4基因型之一的表型表明他汀类药物的剂量。

公开(公告)号：US20150031058A1

公开(公告)日：2015-01-29

申请号：US13949847

申请日：2013-07-24

Applicant: BOSTON HEART DIAGNOSTICS CORPORATION

Inventor： Ernst J. Schaefer

IPC: C12Q1/60

CPC classification number: C12Q1/60 ,  A61K31/366 ,  A61K31/397 ,  A61K31/40 ,  G01N33/5008 ,  G01N33/92

Abstract: Methods of the invention involve determining a patient's compliance with a cholesterol lowering therapy. In certain aspects, the invention provides methods that involve conducting a first assay to determine a cholesterol biomarker level in a first sample from a patient prior to the patient undergoing a cholesterol lowering therapy. The methods may also involve conducting a second assay to determine a cholesterol level in a second sample obtained from the patient after the patient has started undergoing a cholesterol lowering therapy. Additionally, the methods involve associating the cholesterol level and the cholesterol biomarker level in which the association allows for the determination of the patient's compliance with the cholesterol lowering therapy.

Abstract translation: 本发明的方法涉及确定患者对降胆固醇治疗的依从性。 在某些方面，本发明提供了涉及进行第一测定以确定在进行降胆固醇治疗的患者之前来自患者的第一样品中的胆固醇生物标志物水平的方法。 所述方法还可以包括进行第二次测定以确定在患者开始进行降胆固醇治疗之后从患者获得的第二样品中的胆固醇水平。 此外，该方法涉及将胆固醇水平和胆固醇生物标志物水平相关联，其中该关联允许确定患者对降胆固醇治疗的依从性。

公开(公告)号：US20130248370A1

公开(公告)日：2013-09-26

申请号：US13896765

申请日：2013-05-17

Applicant: BOSTON HEART DIAGNOSTICS CORPORATION

Inventor： Bela F. Asztalos ,  Ernst J. Schaefer

IPC: G01N27/447

CPC classification number: G01N33/561 ,  C12M33/00 ,  G01N27/44739 ,  G01N27/44747 ,  G01N27/44778 ,  G01N33/54386 ,  G01N33/6842 ,  G01N33/92 ,  G01N2333/775 ,  G01N2550/00 ,  G01N2800/32 ,  G01N2800/50 ,  G01N2800/52

Abstract: Disclosed are methods and apparatus for separation of biomolecules via two-dimensional gel electrophoresis, methods and apparatus for immunoblotting separated biomolecules, and methods for the use of biomolecules processed via the methods and apparatus of the present invention, including use in a clinical setting. The methods and apparatus for separation of biomolecules via two-dimensional gel comprises vertical agarose gel electrophoresis in the first dimension, and the electrophoresis of a novel non-denaturing 3-35% concave gradient polyacrylamide gel in the second dimension. This novel gel can be cast in a modified gel caster that can facilitate the pouring of multiple gels simultaneously. The methods and apparatus for immunblotting are useful with any type of immunoblotting, including Western blot, Northern blot, and Southern blot analyses. These methods and apparatus provide safe, efficient and cost-effective immunoblots, while facilitating the reduction of exposure to toxic or radioactive materials, as well as the disposal of those materials.

Abstract translation: 公开了通过二维凝胶电泳分离生物分子的方法和装置，用于免疫印迹分离的生物分子的方法和装置，以及使用通过本发明的方法和装置处理的生物分子的方法，包括在临床环境中的用途。 通过二维凝胶分离生物分子的方法和装置包括第一维中的垂直琼脂糖凝胶电泳和第二维中新型非变性3-35％凹梯度聚丙烯酰胺凝胶的电泳。 这种新型凝胶可以浇铸在改良的凝胶浇铸机中，可以同时使多个凝胶倾倒。 用于免疫印迹的方法和装置可用于任何类型的免疫印迹，包括Western印迹，Northern印迹和Southern印迹分析。 这些方法和设备提供安全，有效和经济有效的免疫印迹，同时有助于减少暴露于有毒或放射性物质以及处理这些材料。