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1.发明申请PHOSPHORYLATED C-ErbB2 AS A SUPERIOR PREDICTIVE THERANOSTIC MARKER FOR THE DIAGNOSIS AND TREATMENT OF CANCER 有权磷酸化C-ErbB2作为诊断和治疗癌症的高级预测性治疗标记公开(公告)号：US20110189173A1
公开(公告)日：2011-08-04
申请号：US13003206
申请日：2009-07-08
IPC分类号： A61K39/395 , C40B30/00 , G01N33/574 , A61K31/517 , C12Q1/48 , A61P35/00
CPC分类号： G01N33/57492 , A61K31/517 , A61K39/39558 , A61K2039/505 , C12Q1/6841 , C12Q1/6886 , C12Q2600/106 , C12Q2600/112 , G01N1/30 , G01N33/54366 , G01N33/574 , G01N33/57415 , G01N2033/57403 , G01N2333/71 , G01N2800/52
摘要： The present invention provides reliable methods to identify subsets of subjects with a cancer of epithelial origin characterized by a high level of phosphorylated c-erbB2 which does not correlate with the over-expression of total c-erbB2 as measured by IHC or FISH, for selection and inclusion for c-erbB2-direct treatment and therapy. Furthermore, the present invention provides a reliable method to determine whether a subject with a cancer of epithelial origin who has been determined to be c-erbB2 positive by IHC and by FISH should be excluded from c-erbB2-direct treatment because of a non-significant level of phosphorylated c-erbB2 in epithelial tumor tissue.
摘要翻译： 本发明提供了可靠的方法来鉴定具有上皮起源癌症的受试者的亚群，其特征在于高水平的磷酸化c-erbB2，其与通过IHC或FISH测量的总c-erbB2的过表达不相关，用于选择 并包括c-erbB2直接治疗和治疗。 此外，本发明提供了一种可靠的方法，用于确定由IHC和FISH确定为c-erbB2阳性的具有上皮起源癌症的受试者是否应从c-erbB2直接治疗中排除， 磷酸化c-erbB2在上皮肿瘤组织中的显着水平。
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公开(公告)号：US20100317740A1
公开(公告)日：2010-12-16
申请号：US12669833
申请日：2008-07-28
IPC分类号： A61K31/135 , G01N33/53 , A61P35/04
CPC分类号： G01N33/57415 , G01N2800/52
摘要： This invention relates, e.g., to a method for predicting the response of a subject having, or at risk of developing, breast cancer to Tamoxifen therapy. The method comprises measuring the amount of phosphorylation at residues S70 of Bcl-2, Y992 of EGFR, and/or Y527 of Src in a suitable sample from the subject, wherein a statistically significantly elevated level of phosphorylation at one or more of the three residues compared to a baseline value indicates that the subject is likely to be responsive to Tamoxifen therapy.
摘要翻译： 本发明涉及例如用于预测具有或有发展为乳腺癌患有他莫昔芬治疗的风险的受试者的反应的方法。 该方法包括在来自受试者的合适样品中测量在Bcl-2，Y992的EGFR和/或Src的残基S70处的磷酸化量，其中三个残基中的一个或多个的统计学上显着升高的磷酸化水平 与基线值相比表明受试者可能对他莫昔芬治疗有反应。
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3.发明授权公开(公告)号：US06925389B2
公开(公告)日：2005-08-02
申请号：US09906661
申请日：2001-07-18
CPC分类号： G06F19/24 , G06F19/00 , G06F19/20 , G16H10/40 , G16H50/70 , Y10S707/99933 , Y10S707/99943
摘要： The invention describes a process for determining a biological state through the discovery and analysis of hidden or non-obvious, discriminatory biological data patterns. The biological data can be from health data, clinical data, or from a biological sample, (e.g., a biological sample from a human, e.g., serum, blood, saliva, plasma, nipple aspirants, synovial fluids, cerebrospinal fluids, sweat, urine, fecal matter, tears, bronchial lavage, swabbings, needle aspirantas, semen, vaginal fluids, pre-ejaculate.), etc. which is analyzed to determine the biological state of the donor. The biological state can be a pathologic diagnosis, toxicity state, efficacy of a drug, prognosis of a disease, etc. Specifically, the invention concerns processes that discover hidden discriminatory biological data patterns (e.g., patterns of protein expression in a serum sample that classify the biological state of an organ) that describe biological states.
摘要翻译： 本发明描述了通过发现和分析隐藏或非明显的歧视性生物数据模式来确定生物学状态的过程。 生物数据可以来自健康数据，临床数据或来自生物样品（例如，来自人的生物样品，例如血清，血液，唾液，血浆，乳头吸入剂，滑液，脑脊液，汗液，尿液 ，粪便，眼泪，支气管灌洗液，拭子，针头精液，精液，阴道液，射精前剂量）等进行分析，以确定供体的生物学状态。 生物学状态可以是病理诊断，毒性状态，药物功效，疾病预后等。具体地，本发明涉及发现隐藏的歧视性生物数据模式的过程（例如，血清样品中的蛋白质表达模式，其分类 描述生物状态的器官的生物学状态）。
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公开(公告)号：US09335328B2
公开(公告)日：2016-05-10
申请号：US10182354
申请日：2001-02-02
IPC分类号： G01N33/558 , G01N33/68
CPC分类号： G01N33/6842 , G01N33/5014 , G01N33/502 , G01N33/6803 , G01N33/6845
摘要： An assay device for determining the presence of analytes in a cell lysate comprises a porous support member and a plurality of binding reagents arranged and immobilized at multiple reaction sites on the support member. The binding reagents are selected and arranged to assess the status of a selected cellular signal transduction pathway/protein-protein interactive network. In a further aspect, a method for assessing the status of a signal transduction pathway comprises generating a lysate of cells, the lysate retaining one or more pathway molecules present in one or more states and the pathway molecules reflecting signal transduction events taking place in the cells. The method further includes applying the lysate to an immobilized series of binding reagents which can discriminate the pathway molecules and their states. Binding events between the pathway molecules and the binding reagents are identified and the state of the selected signal pathway is determined.
摘要翻译： 用于确定细胞裂解物中分析物的存在的测定装置包括多孔支撑构件和多个结合试剂，其布置并固定在支撑构件上的多个反应位点处。 选择和排列结合试剂以评估所选择的细胞信号转导途径/蛋白质 - 蛋白质相互作用网络的状态。 在另一方面，用于评估信号转导途径的状态的方法包括产生细胞的裂解物，保留一个或多个状态中存在的一种或多种途径分子的裂解物和反映发生在细胞中的信号转导事件的途径分子 。 该方法还包括将裂解物应用于可以区分途径分子及其状态的固定化的一系列结合试剂。 鉴定途径分子和结合试剂之间的结合事件，并确定所选信号通路的状态。
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公开(公告)号：US20100003247A1
公开(公告)日：2010-01-07
申请号：US12446910
申请日：2007-10-29
IPC分类号： A61K39/395 , C12Q1/02 , A61K31/4545 , A61K31/496 , A61K31/404 , A61K31/517 , A61K31/34 , A61K31/415 , A61P35/00
CPC分类号： G01N33/57419 , C12Q1/485 , G01N2333/90245
摘要： This invention relates, e.g., to a method for predicting the prognosis, the likelihood of metastasis in, or the desirability of administering an aggressive therapy to, a subject with colorectal cancer, comprising determining, in a sample from the subject, the level of phosphorylation compared to a positive and/or negative reference standard, of one or more of: (a) AKT (S473); (b) BAD (S112); (c) cABL (T735); (d) ERK (T42/44); (e) MARCKS (S152-156); (0 p38MAPK (T180-182): (g) STAT 1 (Y701 ); (h) PTEN (S380); (i) EGFR (Y992); (j) PAK 1/2 (S 1 19/204); or (k) PKC zeta/lambda (T410-403); or the total amount of (1) COX-2 protein; wherein if the level of phosphorylation of one or more of a-i or the total amount of COX-2 protein (1) is elevated compared to the negative reference standard, and/or if the level of phosphorylation of j or k is decreased compared to the positive reference standard, the subject has poor prognosis, is likely to undergo metastasis, and/or is a good candidate for aggressive therapy. Also described are methods for treating subjects likely to develop metastatic colorectal carcinoma, and pharmaceutical compositions and kits for implementing methods of the invention.
摘要翻译： 本发明涉及例如用于预测具有结肠直肠癌的受试者的预后，转移的可能性或对其进行侵袭性治疗的可行性的方法，其包括在受试者的样品中测定磷酸化水平 与正和/或负参考标准相比，以下一个或多个：（a）AKT（S473）; （b）BAD（S112）; （c）cABL（T735）; （d）ERK（T42 / 44）; （e）MARCKS（S152-156）; （0 p38MAPK（T180-182）：（g）STAT1（Y701）;（h）PTEN（S380）;（i）EGFR（Y992）;（j）PAK 1/2（S 19/204）;或 （k）PKCζ/λ（T410-403）;或（1）COX-2蛋白的总量;其中如果ai中的一种或多种或COX-2蛋白（1）的总量的磷酸化水平， 与阴性参考标准相比升高，和/或如果j或k的磷酸化水平与阳性参照标准相比降低，则受试者的预后不良，可能经历转移，和/或是 还描述了治疗可能产生转移性结直肠癌的受试者的方法，以及用于实施本发明方法的药物组合物和试剂盒。
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6.发明授权公开(公告)号：US07333896B2
公开(公告)日：2008-02-19
申请号：US10628137
申请日：2003-07-28
CPC分类号： G01N33/6848 , C40B30/04 , G01N33/6803 , G06F19/20 , G06F19/24 , Y10T436/24
摘要： The present invention relates to a method of quality assurance/quality control for high-throughput bioassay processes. The method includes generating a bioassay process model, and then comparing spectral data based on a combination of a biochip and a test serum to the bioassay process model to determine if the test sample and the bioassay process are producing acceptable data. Alternatively, the method may include comparing spectral data based on a combination of serum and diluents used in an electrospray process to the bioassay process model. If the bioassay process and test sample fall within the model, then the spectrum produced may be further analyzed.
摘要翻译： 本发明涉及高通量生物测定方法的质量保证/质量控制方法。 该方法包括生成生物测定过程模型，然后将基于生物芯片和测试血清的组合的光谱数据与生物测定过程模型进行比较，以确定测试样品和生物测定过程是否产生可接受的数据。 或者，该方法可以包括将基于电喷雾过程中使用的血清和稀释剂的组合的光谱数据与生物测定过程模型进行比较。 如果生物测定过程和测试样品落在模型中，则可以进一步分析产生的光谱。
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7.发明授权Phosphorylated C-ErbB2 as a superior predictive theranostic marker for the diagnosis and treatment of cancer 有权磷酸化的C-ErbB2作为癌症诊断和治疗的优越预测因素公开(公告)号：US09086414B2
公开(公告)日：2015-07-21
申请号：US13003206
申请日：2009-07-08
IPC分类号： A61K39/395 , A01N43/48 , G01N33/53 , G01N33/543 , G01N33/574 , C12Q1/68 , A61K31/517 , G01N1/30 , A61K39/00
CPC分类号： G01N33/57492 , A61K31/517 , A61K39/39558 , A61K2039/505 , C12Q1/6841 , C12Q1/6886 , C12Q2600/106 , C12Q2600/112 , G01N1/30 , G01N33/54366 , G01N33/574 , G01N33/57415 , G01N2033/57403 , G01N2333/71 , G01N2800/52
摘要： The present invention provides reliable methods to identify subsets of subjects with a cancer of epithelial origin characterized by a high level of phosphorylated c-erbB2 which does not correlate with the over-expression of total c-erbB2 as measured by IHC or FISH, for selection and inclusion for c-erbB2-direct treatment and therapy. Furthermore, the present invention provides a reliable method to determine whether a subject with a cancer of epithelial origin who has been determined to be c-erbB2 positive by IHC and by FISH should be excluded from c-erbB2-direct treatment because of a non-significant level of phosphorylated c-erbB2 in epithelial tumor tissue.
摘要翻译： 本发明提供了可靠的方法来鉴定具有上皮起源癌症的受试者的亚群，其特征在于高水平的磷酸化c-erbB2，其与通过IHC或FISH测量的总c-erbB2的过表达不相关，用于选择 并包括c-erbB2直接治疗和治疗。 此外，本发明提供了一种可靠的方法，用于确定由IHC和FISH确定为c-erbB2阳性的具有上皮起源癌症的受试者是否应从c-erbB2直接治疗中排除， 磷酸化c-erbB2在上皮肿瘤组织中的显着水平。
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公开(公告)号：US09012240B2
公开(公告)日：2015-04-21
申请号：US13061507
申请日：2009-08-26
IPC分类号： G01N33/549 , G01N33/53 , G01N33/544 , G01N33/558 , G01N33/52 , G01N33/543
CPC分类号： G01N33/521 , G01N33/54333 , G01N33/54346
摘要： An immunoassay device incorporating porous polymeric capture nanoparticles within either the sample collection vessel or pre-impregnated into a porous substratum within fluid flow path of the analytical device is presented. This incorporation of capture particles within the immunoassay device improves sensitivity while removing the requirement for pre-processing of samples prior to loading the immunoassay device. A preferred embodiment is coreshell bait containing capture nanoparticles which perform three functions in one step, in solution: a) molecular size sieving, b) target analyte sequestration and concentration, and c) protection from degradation. The polymeric matrix of the capture particles may be made of co-polymeric materials having a structural monomer and an affinity monomer, the affinity monomer having properties that attract the analyte to the capture particle. This device is useful for point of care diagnostic assays for biomedical applications and as field deployable assays for environmental, pathogen and chemical or biological threat identification.
摘要翻译： 提供了在分析装置的流体流动路径内将多孔聚合物捕获纳米颗粒结合到样品采集容器中或预浸渍到多孔基质内的免疫测定装置。 这种在免疫测定装置内的捕获颗粒的并入提高了灵敏度，同时在加载免疫测定装置之前消除了样品预处理的要求。 优选的实施方案是含有捕获纳米颗粒的芯壳诱饵，其在一个步骤中在溶液中进行三个功能：a）分子筛分，b）目标分析物螯合和浓缩，以及c）防止降解。 捕获颗粒的聚合物基质可以由具有结构单体和亲和单体的共聚物制成，亲和单体具有将分析物吸引到捕获颗粒的性质。 该设备可用于生物医学应用的护理点诊断分析以及环境，病原体和化学或生物威胁鉴定的现场部署测定。
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9.发明申请EX VIVO THERAPEUTICS SCREENING OF LIVING BONE MARROW CELLS FOR MULTIPLE MYELOMA 审中-公开用于多发性骨髓瘤的生物骨髓细胞的筛查治疗公开(公告)号：US20110207627A1
公开(公告)日：2011-08-25
申请号：US13057978
申请日：2009-08-12
CPC分类号： G01N33/56972 , G01N33/5011 , G01N2333/70596 , G01N2510/00 , G01N2800/52
摘要： Methods of selecting a treatment for a patient with multiple myeloma are provided. Prior to commencing a treatment regime, bone marrow aspirates are isolated from a patient and incubated with one or more candidate therapeutics. The methods identify the therapy or combination of therapies most likely to yield the best results for a particular individual. In addition to improving clinical outcome, such theranostic evaluations dramatically reduce health care costs, by avoiding ineffective therapies. Screening assays for identifying treatments for multiple myeloma also are provided.
摘要翻译： 提供了选择多发性骨髓瘤患者的治疗方法。 在开始治疗方案之前，从患者中分离骨髓抽吸物并与一种或多种候选治疗剂一起温育。 该方法确定最有可能为特定个体产生最佳结果的治疗或疗法组合。 除了改善临床结果之外，这种诊断性评估通过避免无效疗法，大大降低了医疗保健成本。 还提供了用于鉴定多发性骨髓瘤治疗的筛选试验。
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公开(公告)号：US20100203549A1
公开(公告)日：2010-08-12
申请号：US12676257
申请日：2008-09-05
CPC分类号： G01N33/96 , G01N33/5005
摘要： This invention relates, e.g., to a set of calibrants for determining the amount in a sample of an analyte (e.g., a protein, such as a protein that has been post-translationally modified), comprising a plurality of calibrants, which contain a range of amounts (e.g., defined amounts and/or serial dilutions) of the analyte, spanning the expected amount of the analyte in the sample. In each of the calibrants, a defined amount of the analyte is present in the same suitable, biological diluent (e.g., a cell or tissue lysate, or a bodily fluid). In one embodiment of the invention, the diluent reflects the same or a similar biological milieu (proteins, lipids, serum proteins, serum matrix proteins, etc.) as that in the sample in which the analyte to be measured is present. In embodiments of the invention, a single calibrant (e.g., a cell lysate) may comprise as many as hundreds of analytes, and can be used for the quantification of those hundreds of analytes in a sample. Methods are described for performing an assay (e.g. RPMA analysis), in which the calibrants of a set of calibrants of the invention are immobilized on each of the surfaces to which samples to be analyzed are immobilized, thereby providing an internal calibration curve for quantifying an RPMA assay.
摘要翻译： 本发明涉及例如用于确定分析物样品中的量（例如蛋白质，例如经翻译后修饰的蛋白质）的一组校准剂，其包含多个校准物，其包含范围 的分析物的量（例如，定义的量和/或连续稀释度），跨越样品中分析物的预期量。 在每个校准中，一定量的分析物存在于相同的合适的生物稀释剂（例如，细胞或组织裂解液或体液）中。 在本发明的一个实施方案中，稀释剂反映与待测分析物存在的样品中相同或相似的生物环境（蛋白质，脂质，血清蛋白，血清基质蛋白等）。 在本发明的实施方案中，单个校准物（例如，细胞裂解物）可以包含多达数百种分析物，并且可以用于量化样品中数百种分析物。 描述了用于进行测定（例如RPMA分析）的方法，其中将本发明的一组校准物的校准物固定在固定有待分析样品的每个表面上，从而提供内部校准曲线，用于量化 RPMA测定。
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