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    METHOD FOR DETERMINING THE IN VIVO COMPARABILITY OF BIOLOGIC DRUG AND A REFERENCE DRUG
    1.
    发明申请
    METHOD FOR DETERMINING THE IN VIVO COMPARABILITY OF BIOLOGIC DRUG AND A REFERENCE DRUG 审中-公开
    用于确定生物药物的体内可比性和参考药物的方法

    公开(公告)号：WO2017053792A1

    公开(公告)日：2017-03-30

    申请号：PCT/US2016/053434

    申请日：2016-09-23

    Applicant: BIOANALYTIX, INC.

    Inventor： LI, Lily, Y.t ,  POSS, Kirtland, G. ,  WU, Shiaw-lin ,  GERNICK, Robert

    IPC: G01N33/68

    CPC classification number: G01N33/6848 ,  G01N33/6851

    Abstract: The invention provides a mass-spectroscopic approach for assessing and determining the in vivo comparability of a candidate biologic molecule to a reference biologic molecule. The results can be presented in the form of an in vivo comparability profile, which can serve as a development tool, e.g., as a guide or target for the development of biologies, biosimilars,or gene therapy-based drugs. The invention further provides an approach using an in vivo comparability profile for measuring the similarity of two biologies, for example, a biosimilar and a reference approved biologic or manufacturing lots of the same biologic to confirm acceptable release criteria for a particular manufacturing lot.

    Abstract translation: 本发明提供了用于评估和确定候选生物分子与参考生物分子的体内可比性的质谱分析方法。 结果可以以体内可比性分布的形式呈现，其可以用作开发工具，例如作为用于开发生物制品，生物仿制品或基于基因治疗的药物的指导或目标。 本发明还提供了一种使用体内可比性分布的方法，用于测量两种生物制品的相似性，例如生物仿制药和相同生物制品的参考批准的生物制品或制造批次，以确定特定制造批次的可接受的释放标准。

    PREDICTIVE TEST FOR MELANOMA PATIENT BENEFIT FROM PD-1 ANTIBODY DRUG AND CLASSIFIER DEVELOPMENT METHODS
    3.
    发明申请
    PREDICTIVE TEST FOR MELANOMA PATIENT BENEFIT FROM PD-1 ANTIBODY DRUG AND CLASSIFIER DEVELOPMENT METHODS 审中-公开
    PD-1抗体药物和分类器开发方法对梅毒患者的预期益处

    公开(公告)号：WO2017011439A1

    公开(公告)日：2017-01-19

    申请号：PCT/US2016/041860

    申请日：2016-07-12

    Applicant: BIODESIX, INC.

    Inventor： RÖDER, Joanna ,  MEYER, Krista ,  GRIGORIEVA, Julia ,  TSYPIN, Maxim ,  OLIVEIRA, Carlos ,  STEINGRIMSSON, Arni ,  RÖDER, Heinrich ,  ASMELLASH, Senait ,  SAYERS, Kevin ,  MAHER, Caroline ,  WEBER, Jeffrey

    IPC: G01N33/574 ,  G01N33/68 ,  G01N30/72 ,  G06F19/24 ,  H01J49/26

    CPC classification number: G16H20/30 ,  G01N33/5743 ,  G01N33/6851 ,  G01N2333/70532 ,  G01N2800/52 ,  G06F19/00 ,  G06F19/24 ,  G06F19/3456 ,  G06F19/3481 ,  G16H20/10

    Abstract: A method is disclosed of predicting cancer patient response to immune checkpoint inhibitors, e.g., an antibody drug blocking ligand activation of programmed cell death 1 (PD-1) or CTLA4. The method includes obtaining mass spectrometry data from a blood-based sample of the patient, obtaining integrated intensity values in the mass spectrometry data of a multitude of pre-determined mass-spectral features; and operating on the mass spectral data with a programmed computer implementing a classifier. The classifier compares the integrated intensity values with feature values of a training set of class-labeled mass spectral data obtained from a multitude of melanoma patients with a classification algorithm and generates a class label for the sample. A class label "early" or the equivalent predicts the patient is likely to obtain relatively less benefit from the antibody drug and the class label "late" or the equivalent indicates the patient is likely to obtain relatively greater benefit from the antibody drug.

    Abstract translation: 公开了一种预测癌症患者对免疫检查点抑制剂的反应的方法，例如抗体药物阻断配体激活程序性细胞死亡1（PD-1）或CTLA4。 该方法包括从患者的血液样品获得质谱数据，获得众多预定质谱特征的质谱数据中的积分强度值; 并使用实现分类器的编程计算机对质谱数据进行操作。 分类器将积分强度值与通过分类算法从多个黑素瘤患者获得的类别标记质谱数据的训练集的特征值进行比较，并生成样本的类标签。 类别标签“早期”或等同物预测患者可能从抗体药物和类标签“晚期”获得相对较少的益处，或等同物表示患者可能从抗体药物获得相对较大的益处。

    METHODS FOR DATA-DEPENDENT MASS SPECTROMETRY OF MIXED BIOMOLECULAR ANALYTES
    4.
    发明申请
    METHODS FOR DATA-DEPENDENT MASS SPECTROMETRY OF MIXED BIOMOLECULAR ANALYTES 审中-公开
    混合生物分析仪的数据依赖性质谱分析方法

    公开(公告)号：WO2016145331A1

    公开(公告)日：2016-09-15

    申请号：PCT/US2016022051

    申请日：2016-03-11

    Applicant: THERMO FINNIGAN LLC

    Inventor： YIP PING F ,  STEPHENSON JAMES L ,  GVOZDYAK OKSANA

    IPC: H01J49/00

    CPC classification number: H01J49/0036 ,  G01N33/6848 ,  G01N33/6851 ,  H01J49/0031 ,  H01J49/004

    Abstract: A method for mass spectral analysis of a sample containing a plurality of biomolecule species comprises: (a) mass analyzing a plurality of first-generation ion species generated from a sample portion; (b) automatically recognizing, for each of at least one biomolecule species, a respective subset of m/z ratios corresponding to respective first-generation ion species generated from the each biomolecule species; (c) selecting, from each recognized subset, a single representative m/z ratio; (d) isolating a sub-population of ions having each representative m/z ratio from ions having other m/z ratios; and (e) fragmenting each isolated sub-population of ions so as to generate second-generation ion species.

    Abstract translation: 包含多个生物分子物质的样品的质谱分析方法包括：（a）质量分析从样品部分产生的多个第一代离子物质; （b）对于至少一种生物分子物种中的每一种，自动识别对应于从每个生物分子物种产生的各自的第一代离子物种的m / z比率的相应子集; （c）从每个识别的子集中选择单个代表性的m / z比; （d）从具有其他m / z比的离子分离具有每个代表性m / z比的离子的子群; 和（e）将每个分离的离子子群体分段，以产生第二代离子物质。

    EARLY DETECTION OF HEPATOCELLULAR CARCINOMA IN HIGH RISK POPULATIONS USING MALDI-TOF MASS SPECTROMETRY
    9.
    发明申请
    EARLY DETECTION OF HEPATOCELLULAR CARCINOMA IN HIGH RISK POPULATIONS USING MALDI-TOF MASS SPECTROMETRY 审中-公开
    使用MALDI-TOF质谱法检测高风险人群中的肝细胞癌

    公开(公告)号：WO2016089553A1

    公开(公告)日：2016-06-09

    申请号：PCT/US2015/059865

    申请日：2015-11-10

    Applicant: BIODESIX, INC.

    Inventor： RÖDER, Joanna ,  OLIVEIRA, Carlos ,  GRIGORIEVA, Julia ,  RÖDER, Heinrich ,  MAHALINGHAM, Devalingham

    IPC: G01N33/574 ,  G01N24/00 ,  H01J49/00

    CPC classification number: H01J49/0036 ,  G01N33/57438 ,  G01N33/6851 ,  G06F19/00 ,  G06K9/00147 ,  G06K9/00536 ,  G06K9/6228 ,  G06K9/6276 ,  G16H10/40 ,  G16H50/70 ,  H01J49/164 ,  Y02A90/26

    Abstract: Hepatocellular carcinoma (HCC) is detected in a patient with liver disease. Mass spectrometry data from a blood-based sample from the patient is compared to a reference set of mass-spectrometry data from a multitude of other patients with liver disease, including patients with and without HCC, in a general purpose computer configured as a classifier. The classifier generates a class label, such as HCC or No HCC, for the test sample, A laboratory system for early detection of HCC in patients with liver disease is also disclosed. Alternative testing strategies using AFP measurement and a reference set for classification in the form of class-labeled mass spectral data from blood-based samples of lung cancer patients are also described, including multi-stage testing.

    Abstract translation: 在肝病患者中检测到肝细胞癌（HCC）。 将来自患者的血液样品的质谱数据与来自多个其他肝病患者的质谱数据进行比较，所述其他患者包括具有和不具有HCC的患者，在配置为分类器的通用计算机中。 分类器为测试样品生成类标签，如HCC或无HCC，还披露了肝病患者HCC早期检测实验室系统。 还描述了使用AFP测量和来自肺癌患者血液样品的类标记质谱数据形式的分类参考文献的替代测试策略，包括多阶段测试。

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