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1. 发明申请

WO2013033049A8 BIOCOATED PIEZOELECTRIC BIOSENSOR PLATFORM FOR POINT-OF-CARE DIAGNOSTIC USE 审中-公开
公开(公告)号：WO2013033049A8
公开(公告)日：2013-03-07
申请号：PCT/US2012/052583
申请日：2012-08-27
申请人： AVIANA MOLECULAR TECHNOLOGIES, LLC , LAURY-KLEINTOP, Lisa , OU, Hsu-Cheng , RUTNER, Herman
发明人： LAURY-KLEINTOP, Lisa , OU, Hsu-Cheng , RUTNER, Herman
IPC分类号： H01L41/00
摘要： Biosensor components (chips )are described based on direct biocoating processes that result in the tenacious and stable, noncovalent (believed to be chemisorptive) binding of anchor substances such as avidin(s) other proteins having specific binding partners or oligo- or poly-nucleotides onto any piezoelectrically active crystal surface. The resulting platform technology can be developed for a variety of biosensors with specific applications in biological assays. The table monolayers of the anchor substances forms reactive layers, ready to bind a capture reagent such as a biotinylated antibody for capture and detection of analytes in biologic fluid samples. Although the processes described herein can be performed on any type of piezoelectric material in any number of configurations, some embodiments are directed to a biosensor with the foregoing biocoating onto a particular acoustic plate mode biosensor and where the interdigitated transducers (IDTs) are present on the opposite side of the crystal's biocoated film.

2. 发明申请

WO2010138871A1 INTEGRATED MICROCHIP SURFACE ACOUSTIC WAVE SENSOR SYSTEM FOR DETECTION OF INFECTIOUS AGENTS 审中-公开
标题翻译：一体化微波表面声波传感器系统，用于检测感染性细胞
公开(公告)号：WO2010138871A1
公开(公告)日：2010-12-02
申请号：PCT/US2010/036662
申请日：2010-05-28
申请人： AVIANA MOLECULAR TECHNOLOGIES, LLC , RAGAVAN, Vanaja, Vijaya , ROY, Avijit , RUTNER, Herman
发明人： RAGAVAN, Vanaja, Vijaya , ROY, Avijit , RUTNER, Herman
IPC分类号： G01N29/02 , G01N29/22 , G01N30/00 , G01N33/00
CPC分类号： G01N29/022 , G01N29/222 , G01N29/226 , G01N33/54373 , G01N33/569 , G01N2291/0255 , G01N2291/0256 , G01N2291/0423 , G01N2291/106 , Y02A50/53
摘要： An integrated multiplexed acoustic wave biosensor chip system with enhanced sensitivity has been developed. The biosensor system incorporates one or more microfluidic channels, coated with target-specific binding films enabling rapid and early detection of viral, bacterial or parasitic targets such as Dengue virus and sexually transmitted diseases in specimens from potentially infected patients. The biosensors are used in portable analytical systems that are suitable for real-time point of care (POC) clinical diagnosis in cost sensitive and/or resource limited settings. The highly sensitive biosensors utilize thinned single crystal piezoelectric substrates that propagate layer guided shear horizontal acoustic plate mode (LG-SH-APM) waves in sensing regions bearing immobilized binders that provide simultaneous and direct detection of mass changes due to multiple bound target pathogens or molecules.
摘要翻译：已经开发了具有增强的灵敏度的集成多声道声波生物传感器芯片系统。生物传感器系统包含一个或多个微流体通道，涂覆有目标特异性结合膜，能够在潜在感染患者的标本中快速和早期检测病毒，细菌或寄生虫目标，如登革热病毒和性传播疾病。生物传感器用于便携式分析系统，适用于成本敏感和/或资源有限的实时临床诊断中的实时护理点（POC）。高灵敏度的生物传感器利用薄膜单晶压电基片，传播层导向剪切水平声板模式（LG-SH-APM）波在感测具有固定粘合剂的区域，提供同时和直接检测多重结合靶病原体或分子的质量变化。

3. 发明公开

EP2748874A1 BIOCOATED PIEZOELECTRIC BIOSENSOR PLATFORM FOR POINT-OF-CARE DIAGNOSTIC USE 审中-公开
标题翻译： BIOBESCHICHTETE压电生物传感器POC诊断
公开(公告)号：EP2748874A1
公开(公告)日：2014-07-02
申请号：EP12827353.9
申请日：2012-08-27
申请人： Aviana Molecular Technologies, LLC
发明人： LAURY-KLEINTOP, Lisa , OU, Hsu-Cheng , RUTNER, Herman
IPC分类号： H01L41/00
CPC分类号： G01N33/54306 , B05D3/142 , G01D5/14 , G01N29/02 , G01N29/022 , G01N29/22 , G01N29/34 , G01N29/36 , G01N33/54386 , G01N33/551 , G01N33/56927 , G01N33/56983 , G01N2291/0255 , G01N2291/0256 , G01N2291/0427 , H01L41/113 , H01L41/253
摘要： Biosensor components (chips) are described based on direct biocoating processes that result in the tenacious and stable, noncovalent (believed to be chemisorptive) binding of anchor substances such as avidin(s) other proteins having specific binding partners or oligo- or poly-nucleotides onto any piezo-electrically active crystal surface. The resulting platform technology can be developed for a variety of biosensors with specific applications in biological assays. The table mono layers of the anchor substances forms reactive layers, ready to bind a capture reagent such as a biot-inylated antibody for capture and detection of analytes in biologic fluid samples. Although the processes described herein can be performed on any type of piezoelectric material in any number of configurations, some embodiments are directed to a biosensor with the foregoing biocoating onto a particular acoustic plate mode biosensor and where the interdigitated transducers (IDTs) are present on the opposite side of the crystal's biocoated film.

4. 发明申请

WO2005049168A2 METHOD AND APPARATUS FOR PRE-ENRICHMENT AND RECOVERY OF CELLS FROM DENSIFIED WHOLE BLOOD 审中-公开
标题翻译：从浓缩全血中预先富集和回收细胞的方法和设备
公开(公告)号：WO2005049168A2
公开(公告)日：2005-06-02
申请号：PCT/US2004/038609
申请日：2004-11-17
申请人： IMMUNIVEST CORPORATION , GROSS, Steven , RUTNER, Herman
发明人： GROSS, Steven , RUTNER, Herman
IPC分类号： B01D
CPC分类号： A01N1/02 , A01N1/0263
摘要： The present invention describes reagents, methods and apparatus for pre-processing of blood samples to obtain blood fractions containing substantially all target cells in reduced specimen volumes that are suitable for subsequent further enrichment. Sample processor systems are described for enriching cell populations having densities of less than approximately 1.09 g/ml from about 30 ml whole blood. Whole blood is combined with a cell compatible dense reagent to raise the density to about 1.09 g/ml. Centrifugation causes the target cells and most of the WBC in the buffy coat layer to accumulate at the top under a low-density buffer overlay. The reduced sample volumes are suitable for subsequent immunomagnetic or other enrichment methods prior to detection and enumeration. These processor systems, in conjunction with other enrichment procedures, facilitate detection of rare target cells, such as circulating tumor cells (CTC) that are useful markers in cancer diagnosis and monitoring of therapeutic response.
摘要翻译：本发明描述了用于对血液样品进行预处理以获得含有基本上全部靶细胞的血液馏分的试剂，方法和设备，所述血液馏分具有适合于随后进一步富集的减少的样本体积。描述了用于从约30ml全血富集密度小于约1.09g / ml的细胞群的样品处理器系统。将全血与细胞相容致密试剂组合以将密度提高至约1.09g / ml。离心使血块层中的靶细胞和大部分WBC在低密度缓冲覆盖层下积聚在顶部。在检测和计数之前，减少的样品体积适合随后的免疫磁性或其他富集方法。这些处理器系统与其他富集程序相结合，有助于检测罕见的靶细胞，如循环肿瘤细胞（CTC），这些细胞是癌症诊断和治疗反应监测的有用标记物。

5. 发明申请

WO2006054991A1 MAGNETIC ENRICHMENT OF CIRCULATING CELLS, FRAGMENTS AND DEBRIS FOR ENABLING HTS PROTEOMICS AND GENOMICS IN DISEASE DETECTION 审中-公开
标题翻译：循环细胞的磁性增殖，用于启动HTS预防和疾病感染的基因组的片段和修饰
公开(公告)号：WO2006054991A1
公开(公告)日：2006-05-26
申请号：PCT/US2004/038608
申请日：2004-11-17
申请人： IMMUNIVEST CORPORATION , DOYLE, Gerald, V. , O'HARA, Shawn, Mark , RUTNER, Herman
发明人： DOYLE, Gerald, V. , O'HARA, Shawn, Mark , RUTNER, Herman
IPC分类号： G01N33/574 , G01N33/567 , G01N33/566 , B03C1/00 , C07K16/00
CPC分类号： G01N33/574 , G01N33/5091
摘要： The methods and reagents described in this invention are used to analyze circulating tumor cells, clusters, fragments, and debris. Analysis is performed with a number of platforms, including flow cytometry, CellSpotter TM fluorescent microscopy imaging andmass spectrometric profiling. In addition to analyzing and enumerating morphologicaly classified cells by imaging, the presence of damaged cells and derived debris in magnetically enriched specimens has been shown to be an important “smoking gun” indicator of demised tumor cells. Described herein are improved methods to screen, diagnose and monitor disease based on intact circulating rare cells and associated fragments or debris. The present invention incorporates proteomic and genomic profiling of cellular debris in cancer cell analysis, either complementary to or independent of image cytometry. The technology provides diagnosis and prognostic tools in diseases such as cancer that incorporate not only detection and quantitation of intact circulating cells but also of cellular fragments and debris that bear generic cytoskeletal and/or tumor-specific markers. The presence of such markers reflects immune function in early disease and/or therapeutic effectiveness in later stages.
摘要翻译：本发明描述的方法和试剂用于分析循环肿瘤细胞，簇，碎片和碎片。使用许多平台进行分析，包括流式细胞术，CellSpotter TM荧光显微镜成像和质谱分析。除了通过成像分析和列举形态分类的细胞之外，磁性富集标本中损伤的细胞和衍生碎片的存在已经被证明是消除肿瘤细胞的重要的“吸烟枪”指标。本文描述了基于完整的循环稀有细胞和相关片段或碎片筛选，诊断和监测疾病的改进方法。本发明将细胞碎片的蛋白质组学和基因组分析结合在癌细胞分析中，与图像细胞计数的补充或独立。该技术在诸如癌症的疾病中提供了诊断和预后工具，其不仅包括完整的循环细胞的检测和定量，而且还包含具有通用细胞骨架和/或肿瘤特异性标志物的细胞碎片和碎片。这种标志物的存在反映早期疾病中的免疫功能和/或后期阶段的治疗有效性。

6. 发明申请

WO2005028663A3 OPERATOR INDEPENDENT PROGRAMMABLE SAMPLE PREPARATION AND ANALYSIS SYSTEM 审中-公开
公开(公告)号：WO2005028663A3
公开(公告)日：2005-03-31
申请号：PCT/US2004/030429
申请日：2004-09-17
申请人： IMMUNIVEST CORPORATION , BENDELE, Teresa , HARBART, Thomas , HOWARD, Dave , KAGAN, Michael , KEENE, Douglas , LAPEUS, Dave , MAYES, Jared , PAYNTER, Douglas , PROHASKA, Jerry , RUTNER, Herman
发明人： BENDELE, Teresa , HARBART, Thomas , HOWARD, Dave , KAGAN, Michael , KEENE, Douglas , LAPEUS, Dave , MAYES, Jared , PAYNTER, Douglas , PROHASKA, Jerry , RUTNER, Herman
IPC分类号： G01N21/00
摘要： The present invention provides a protocol and apparatus for enriching circulating tumor cells and other rare cells from blood, including debris and other components, from samples with high precision and at high throughput rates. This invention discloses an improved processing system from previously described semi-automated sample processing. The system further reduces operator intervention and hands-on time from prior systems. While this system has general utility in processing diverse materials, the system is configured for sample processing of biological specimens to provide an enriched fraction suitable for detection, enumeration and identification of target cells by appropriate analytical methodologies. The presence and quantities of such target cells in a sample specimen can utilized for screening and detection in disease such as cancer, assessing early stage pre-metastatic cancer, monitoring for disease remission in response to therapy and selection of more effective dose regimens or alternative therapies in case of relapse.

7. 发明申请

WO2003019141A3 ANALYSIS OF CIRCULATING TUMOR CELLS, FRAGMENTS, AND DEBRIS 审中-公开
公开(公告)号：WO2003019141A3
公开(公告)日：2003-03-06
申请号：PCT/US2002/026861
申请日：2002-08-23
申请人： IMMUNIVEST CORPORATION , RAO, Galla, Chandra , LARSON, Christopher , REPOLLET, Madeline , RUTNER, Herman , TERSTAPPEN, Leon , O'HARA, Shawn, Mark , GROSS, Steven
发明人： RAO, Galla, Chandra , LARSON, Christopher , REPOLLET, Madeline , RUTNER, Herman , TERSTAPPEN, Leon , O'HARA, Shawn, Mark , GROSS, Steven
IPC分类号： C07K1/00
摘要： The methods and reagents described in this invention are used to analyze circulating tumor cells, clusters, fragments, and debris. Analysis is performed with a number of platforms, including flow cytometry and the CellSpotter® fluorescent microscopy imaging system. Analyzing damaged cells has shown to be important. However, there are two sources of damage: in vivo and in vitro . Damage in vivo occurs by apoptosis, necrosis, or immune response. Damage in vitro occurs during sample acquisition, handling, transport, processing, or analysis. It is therefore desirable to confine, reduce, eliminate, or at least qualify in vitro damage to prevent it from interfering in analysis. Described herein are methods to diagnose, monitor, and screen disease based on circulating rare cells, including malignancy as determined by CTC, clusters, fragments, and debris. Also provided are kits for assaying biological specimens using these methods.

8. 发明申请

WO2003019141A2 ANALYSIS OF CIRCULATING TUMOR CELLS, FRAGMENTS, AND DEBRIS 审中-公开
标题翻译：循环肿瘤细胞，片段和DEBRIS的分析
公开(公告)号：WO2003019141A2
公开(公告)日：2003-03-06
申请号：PCT/US2002/026861
申请日：2002-08-23
申请人： IMMUNIVEST CORPORATION , RAO, Galla, Chandra , LARSON, Christopher , REPOLLET, Madeline , RUTNER, Herman , TERSTAPPEN, Leon , O'HARA, Shawn, Mark , GROSS, Steven
发明人： RAO, Galla, Chandra , LARSON, Christopher , REPOLLET, Madeline , RUTNER, Herman , TERSTAPPEN, Leon , O'HARA, Shawn, Mark , GROSS, Steven
IPC分类号： G01N
CPC分类号： A01N1/02 , A01N1/00 , A01N1/0226 , G01N33/54333 , G01N33/574
摘要： The methods and reagents described in this invention are used to analyze circulating tumor cells, clusters, fragments, and debris. Analysis is performed with a number of platforms, including flow cytometry and the CellSpotter®* fluorescent microscopy imaging system. Analyzing damaged cells has shown to be important. However, there are two sources of damage: in vivo and in vitro . Damage in vivo occurs by apoptosis, necrosis, or immune response. Damage in vitro occurs during sample acquisition, handling, transport, processing, or analysis. It is therefore desirable to confine, reduce, eliminate, or at least qualify in vitro damage to prevent it from interfering in analysis. Described herein are methods to diagnose, monitor, and screen disease based on circulating rare cells, including malignancy as determined by CTC, clusters, fragments, and debris. Also provided are kits for assaying biological specimens using these methods.
摘要翻译：本发明描述的方法和试剂用于分析循环肿瘤细胞，簇，碎片和碎片。使用多种平台进行分析，包括流式细胞术和CellSpotter3 *荧光显微镜成像系统。分析损伤的细胞已被证明是重要的。然而，有两个损害来源：体内和体外。体内损伤是通过细胞凋亡，坏死或免疫应答发生的。在样品采集，处理，运输，加工或分析过程中发生体外损伤。因此，期望限制，减少，消除或至少限定体外损伤，以防止其干扰分析。本文描述了基于循环稀有细胞（包括由CTC，簇，碎片和碎片确定的恶性肿瘤）来诊断，监测和筛选疾病的方法。还提供了使用这些方法测定生物样品的试剂盒。

9. 发明申请

WO2003018757A2 STABILIZATION OF CELLS AND BIOLOGICAL SPECIMENS FOR ANALYSIS 审中-公开
标题翻译：用于分析的细胞和生物标本的稳定化
公开(公告)号：WO2003018757A2
公开(公告)日：2003-03-06
申请号：PCT/US2002/026867
申请日：2002-08-23
申请人： IMMUNIVEST CORPORATION , RAO, Galla, Chandra , HERMANN, Melissa , RUTNER, Herman , TERSTAPPEN, Leon
发明人： RAO, Galla, Chandra , HERMANN, Melissa , RUTNER, Herman , TERSTAPPEN, Leon
IPC分类号： C12N
CPC分类号： A01N1/02 , A01N1/00 , A01N1/0226 , G01N33/54333 , G01N33/574
摘要： Compositions and methods for stabilizing rare cells in blood specimens, preserving the quality of blood specimens, and also serving as cell fixatives are disclosed which minimize losses of target cells (for example, circulating tumor cells) and formation of debris and aggregates from target cells, non-target cells and plasma components, thereby allowing more accurate analysis and classification of circulating tumor cells (CTC) and, ultimately, of tumor burdens in cancer patients. Stabilization of specimens is particularly desirable n protocols requiring rare cells enrichment from blood specimens drawn from cancer patients. Exposure of such specimens to potentially stressful conditions encountered, for example, in normal processing, mixing, shaking, delays due to transporting the blood, has been observed to not only diminish the number of CTC but also to generate debris and aggregates in the blood specimens that were found to interfere with accurate enumeration of target cells, if present. Stabilizers are necessary to discriminate between in vivo CTC disintegration and in vitro sample degredation.
摘要翻译：公开了用于稳定血液样本中的稀有细胞，保持血液样本的质量并且还用作细胞固定剂的组合物和方法，其使靶细胞（例如循环肿瘤细胞）的损失最小化并且形成来自靶细胞，非靶细胞和血浆成分的碎片和聚集物，从而允许更准确地分析和分类循环肿瘤细胞（CTC）并最终确定癌症患者的肿瘤负荷。在需要从癌症患者抽取的血样中富集稀有细胞的方案中，标本的稳定化是特别希望的。已经观察到将这些标本暴露于潜在的应激条件下，例如在正常的处理，混合，摇动，由于输送血液引起的延迟中，遇到的不仅会减少CTC的数量，而且还会在血液样本中产生碎片和聚集体如果存在的话，发现它们会干扰精确计数的靶细胞。稳定剂是区分体内CTC崩解和体外样品降解所必需的。

10. 发明申请

WO2002077604A3 LABELED CELLS FOR USE AS AN INTERNAL FUNCTIONAL CONTROL IN RARE CELL DETECTION ASSAYS 审中-公开
公开(公告)号：WO2002077604A3
公开(公告)日：2002-10-03
申请号：PCT/US2002/006967
申请日：2002-03-07
申请人： IMMUNIVEST CORPORATION , TERSTAPPEN, Leon, W., M., M. , RAO, Galla, Chandra , RUTNER, Herman , LIBERTI, Paul, A.
发明人： TERSTAPPEN, Leon, W., M., M. , RAO, Galla, Chandra , RUTNER, Herman , LIBERTI, Paul, A.
IPC分类号： A01N1/02
摘要： Stabilized control cells, methods for making the same and kits comprising the stabilized cells are disclosed. Also provided are improved methods for detecting rare cells in biological samples.

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