公开(公告)号：US20240400672A1

公开(公告)日：2024-12-05

申请号：US18662694

申请日：2024-05-13

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Michael Gerg ,  Klaus Hirzel ,  Caroline Dorothea Hojer ,  Hans-Peter Josel ,  Ute Jucknischke ,  Holger Lehmann ,  Anastasia Markina ,  Giuseppe Prencipe ,  Leopold von Proff ,  Michael Schraeml ,  Steinar Halldórsson

IPC: C07K16/26 ,  G01N33/78

Abstract: The present invention provides a novel monoclonal antibody specifically binding to L-Thyroxine (T4) and compositions and kits comprising such antibodies. Furthermore, provided are polynucleotides encoding such monoclonal antibodies, host cells expressing said antibodies, methods of producing such antibodies and diagnostic methods using such monoclonal antibodies. The monoclonal antibody of the invention comprises a heavy chain variable domain (VH) comprising V or A in position 33; Y in position 50; W in position 52; I in position 98, G, A or V in position 99; Y in position 100; and I in position 100b; and a light chain variable domain (VL) comprising amino acids H or Y in position 28; N or K in position 29; W in position 32; G or A in position 91; Y, W or F in position 92; S or T in position 93; Y or F in position 95b; N, S, T or Q in position 95c; and H in position 96, wherein the positions of the amino acids in the VH and the VL are indicated according to the Kabat numbering scheme, respectively.

公开(公告)号：US20240140995A1

公开(公告)日：2024-05-02

申请号：US18542054

申请日：2023-12-15

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Romina Eisenhauer ,  Alfred Engel ,  Ute Jucknischke ,  Michael Schraeml ,  Wojtek Steffen

IPC: C07K14/195 ,  G01N33/543

CPC classification number: C07K14/195 ,  G01N33/54353 ,  C07K2319/00 ,  G01N2333/245

Abstract: The present invention relates to a method of determining an analyte in a sample, said method comprising (a) contacting said sample with (i) a binding compound binding to said analyte, said binding compound comprising a binding agent and a first partner of an affinity pair (first affinity partner); and (ii) a second partner of the affinity pair (second affinity partner) coupled to a solid surface, to an indicator, and/or to a second binding agent; and (b) determining said analyte based on complexes formed in step (a); wherein one of said first affinity partner and said second affinity partner is a polypeptide comprising the amino acid sequence of SEQ ID NO:1 or a sequence at least 50% identical thereto, and wherein the other of said first affinity partner and said second affinity partner is a polypeptide comprising the amino acid sequence of SEQ ID NO:2 or a sequence at least 50% identical thereto. The present invention also relates to a polypeptide comprising an amino acid sequence as specified in SEQ ID NO:1 or a sequence at least 50% identical thereto, wherein the amino acid at the position corresponding to position 77 in SEQ ID NO:1 is not a histidine; and to a polypeptide comprising an amino acid sequence as specified in SEQ ID NO:2 or a sequence at least 50% identical thereto, wherein (i) the amino acid at the position corresponding to position 17 in SEQ ID NO:2 is not a cysteine, in an embodiment is alanine, serine, leucine, isoleucine, or glycine and/or (ii) said polypeptide further comprises at least one functional peptide; and to fusion polypeptides, polypeptide complexes, polynucleotides and kit related to the aforesaid.

公开(公告)号：US20190324024A1

公开(公告)日：2019-10-24

申请号：US16450176

申请日：2019-06-24

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Michael Gerg ,  Klaus Hirzel ,  Caroline Dorothea Hojer ,  Erasmus Huber ,  Hans-Peter Josel ,  Thomas Meier ,  Michael Schraeml ,  Leopold Von Proff

IPC: G01N33/543 ,  C07K16/44

Abstract: The present invention relates to a monoclonal antibody capable of binding to biotin. In one embodiment the monoclonal antibody according to the invention also does not bind to a biotin moiety on a biotinylated molecule, wherein the biotin moiety is attached to the molecule via the carbon atom of the carboxyl function of the valeric acid moiety of biotin. Also disclosed is a method for generation of an antibody as disclosed herein. The monoclonal antibody according to the invention is of specific use in a method for measuring an analyte in a sample, wherein a (strept)avidin/biotin pair is used to bind a biotinylated analyte specific binding agent to a (strept)avidin coated solid phase.

公开(公告)号：US10421997B2

公开(公告)日：2019-09-24

申请号：US15121220

申请日：2015-02-03

Applicant: ROCHE DIAGNOSTICS OPERATIONS, INC. ,  DYNAMIC BIOSENSORS GMBH

Inventor： Dieter Heindl ,  Andreas Langer ,  Ulrich Rant ,  Ralf Strasser ,  Michael Schraeml

IPC: C12Q1/6869 ,  G01N27/327

Abstract: The present invention relates to a method of identifying a nucleotide at a defined position and determining the sequence of a target polynucleotide using an electro-switchable biosensor, as well as devices comprising an electro-switchable biosensor and uses thereof.

公开(公告)号：US20160252500A1

公开(公告)日：2016-09-01

申请号：US15146226

申请日：2016-05-04

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Michael Schraeml ,  Markus Roessler ,  Michael Gerg

IPC: G01N33/543

Abstract: The present invention relates to a method for determining the total amount and/or concentration of an analyte in the presence of a binding molecule as well as kits, compositions and uses relating thereto.

Abstract translation: 本发明涉及用于在结合分子存在下测定分析物的总量和/或浓度的方法以及与其相关的试剂盒，组合物和用途。

公开(公告)号：US09273144B2

公开(公告)日：2016-03-01

申请号：US14069445

申请日：2013-11-01

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Herbert Andres ,  Hartmut Duefel ,  Michael Gerg ,  Frank Kowalewsky ,  Christian Scholz ,  Michael Schraeml

IPC: C07K16/00 ,  C07K16/40 ,  C07K16/22 ,  C12N9/90 ,  C07K16/12 ,  G01N33/74 ,  G01N33/573

CPC classification number: C07K16/22 ,  C07K14/475 ,  C07K14/65 ,  C07K16/1203 ,  C07K16/40 ,  C07K2317/34 ,  C07K2317/565 ,  C07K2317/92 ,  C07K2319/00 ,  C07K2319/21 ,  C07K2319/22 ,  C07K2319/23 ,  C07K2319/24 ,  C07K2319/35 ,  C07K2319/41 ,  C07K2319/43 ,  C12N9/90 ,  C12Y502/01008 ,  G01N33/573 ,  G01N33/74 ,  G01N2333/99

Abstract: Isolated antibodies that specifically bind to an epitope comprised in the stretch of amino acids ranging from amino acid 76 to amino acid 84 of human insulin-like growth factor-1 precursor (SEQ ID NO:1). Use of the novel antibodies for the sensitive and specific detection of insulin-like growth factor-1, in some embodiments while in the presence of high excess concentration of insulin-like growth factor-2, for example in a bodily fluid sample.

Abstract translation: 分离的抗体特异性结合包含在人类胰岛素样生长因子-1前体的氨基酸76至氨基酸84的氨基酸区段中的表位（SEQ ID NO：1）。 在一些实施方案中，当存在高过量浓度的胰岛素样生长因子-2（例如在体液样品中）时，使用新型抗体用于敏感和特异性检测胰岛素样生长因子-1。

公开(公告)号：US20250042976A1

公开(公告)日：2025-02-06

申请号：US18704654

申请日：2022-10-25

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Michael Gerg ,  Simon Jochum ,  Ute Jucknischke ,  Ulrike Kurtkaya ,  Michael Schraeml ,  Sandrine Carolina Stiegler

IPC: C07K16/10

Abstract: The present invention relates to monoclonal antibodies binding to the Receptor Binding Domain of the Spike protein of SARS-CoV-2 virus, nucleic acids encoding said antibody, host cells producing the same, compositions and kits comprising said antibodies, method of detecting SARS-CoV-2 virus in a sample comprising using said antibodies and methods of using said antibodies in immunoassays.

公开(公告)号：US12025613B2

公开(公告)日：2024-07-02

申请号：US17551723

申请日：2021-12-15

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Michael Gerg ,  Dieter Heindl ,  Lars Hillringhaus ,  Klaus Hirzel ,  Caroline Dorothea Hojer ,  Florian Huber ,  Hans-Peter Josel ,  Thomas Meier ,  Michael Schraeml ,  Edgar Voss

IPC: G01N33/543 ,  C07K16/44

CPC classification number: G01N33/54306 ,  C07K16/44

Abstract: The present invention relates to a monoclonal antibody capable of binding to biotin. In one embodiment the monoclonal antibody according to the invention also does not bind to a biotin moiety on a biotinylated molecule, wherein the biotin moiety is attached to the molecule via the carbon atom of the carboxyl function of the valeric acid moiety of biotin. Also disclosed is a method for generation of an antibody as discloed herein. The monoclonal antibody according to the invention is of specific use in a method for measuring an analyte in a sample, wherein a (strept)avidin/biotin pair is used to bind a biotinylated analyte specific binding agent to a (strept)avidin coated solid phase.

公开(公告)号：US20230340147A1

公开(公告)日：2023-10-26

申请号：US18187502

申请日：2023-03-21

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Magdalena Swiatek-de Lange ,  Joanna Siebenhaar ,  Carol Jones ,  Thomas Pritchett ,  Andrea Muranyi ,  Caroline Dorothea Hojer ,  Michael Gerg ,  Lars Hillringhaus ,  Gloria Tabares ,  Christian Roessler ,  Michael Schraeml ,  Shalini Singh ,  Theresa Kott

IPC: C07K16/30 ,  G01N33/574 ,  G01N1/30

CPC classification number: C07K16/3069 ,  G01N33/57434 ,  G01N1/30 ,  C07K2317/41 ,  G01N2001/302 ,  C07K2317/33 ,  C07K2317/92

Abstract: The present invention relates to an antibody or an antigen binding fragment thereof that specifically binds to α-1,6-core-fucosylated prostate specific antigen (PSA) and partial sequences thereof comprising the α-1,6-core-fucose residue. The antibodies and antigen binding fragments significantly discriminate between core-fucosylated PSA or core-fucosylated PSA partial sequences and other glycosylated PSA species and partial sequences thereof lacking the core-fucose residue, including aglycosylated PSA, as well as core-fucosylated glycan in other contexts. The present invention further relates to nucleic acid molecules encoding the light chain variable region or the heavy chain variable region of the antibody of the invention, as well as vectors comprising said nucleic acid molecules. The invention also relates to a host cell comprising the vector(s) of the invention, as well as to methods for the production of an antibody or antigen binding fragment of the invention comprising culturing the host cell of the invention under suitable conditions and isolating the antibody produced. Furthermore, the present invention relates to an antibody obtainable by the method of the invention, to a composition comprising at least one of the antibody or antigen binding fragment of the invention, the nucleic acid molecule of the invention, the vector of the invention, the host cell of the invention or the antibody produced by the method of the invention. The present invention also relates to the use of an antibody or antigen binding fragment of the invention for detecting and discriminating core-fucosylated PSA or core-fucosylated partial sequences thereof in biological samples.

公开(公告)号：US20210061924A1

公开(公告)日：2021-03-04

申请号：US17069349

申请日：2020-10-13

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Hartmut Duefel ,  Alfred Engel ,  Frank Kroner ,  Thomas Meier ,  Sandra Rutz ,  Michael Schraeml ,  Gloria Tabares ,  Ulrike Kurtkaya ,  Boris Pinchuk ,  Christina Zimmermann

IPC: C07K16/40 ,  G01N33/543

Abstract: The present invention relates to a novel monoclonal antibody that specifically binds to a conformation dependent epitope on human thymidine kinase 1 (hTK-1; SEQ ID NO:1), to methods for quantifying hTK-1 employing the antibody and to the use of the anti-hTK-1 antibody in quantifying hTK-1.