Dade Behring Inc.

Senhwa Biosciences, Inc.

Siemens Healthcare Diagnostics Gmbh

Hshiou-ting Liu

Yi Feng Zheng

Dariush Davalian

Denise Leah Williams

Paul Levi Miller

Kenneth Cornell Kasper

Henry Jeong

Jian Chen

Holger Keim

Johnny Jose Valdez

Mae W Hu

David M Ryckman

Khaled A Yamout

Donald E Berger, Jr

John Soong

Yali Yang

Richard F Parrish

Iching G Yu

Yi-Feng Zheng

Cathy K Worley

Johnny Valdez

The present invention includes a solid lyophilized form of 2-(4-Methyl-[1,4]diazepan-1-yl)-5-oxo-5H-7-thia-1,11b-diaza-benzo[c]fluorene-6-carboxylic acid (5-methyl-pyrazin-2-ylmethyl)-amide (Compound I) and the process of producing the solid lyophilized form. Furthermore, the present invention provides compositions comprising Compound I, or a pharmaceutically acceptable salt and/or solvate thereof and therapeutic use of the composition.

Quinolone analogs and their salts, compositions, and method for their use

The present invention includes crystalline forms of 2-(4-Methyl-[1,4]diazepan-1-yl)-5-oxo-5H-7-thia-1,11b-diaza-benzo[c]fluorene-6-carboxylic acid (5-methyl-pyrazin-2-ylmethyl)-amide and crystalline forms of salts and/or solvates of 2-(4-Methyl-[1,4]diazepan-1-yl)-5-oxo-5H-7-thia-1,11b-diaza-benzo[c]fluorene-6-carboxylic acid (5-methyl-pyrazin-2-ylmethyl)-amide. Furthermore, the present invention provides compositions comprising the crystalline forms and therapeutic use of the crystalline forms and the compositions thereof.

Crystalline forms of quinolone analogs and their salts

An IgG&#x3bb; monoclonal antibody to the immunosuppressive drug tacrolimus has improved properties. In particular, this monoclonal antibody, designated 1H6, has reduced cross-reactivity to several tacrolimus metabolites. This antibody is suitable for performance of immunoassays such as homogeneous immunoassays to detect or determine the presence or concentration of tacrolimus in samples such as blood samples. The invention further includes derivatives of tacrolimus derivatized at a non-binding portion of the molecule useful in immunizing antibody-producing animals and in producing such monoclonal antibodies, as well as labeled derivatives of tacrolimus useful as tacrolimus analogues in such assays. The invention further includes immunoassay methods for the detection of tacrolimus and test kits useful in performing such immunoassays.

Monoclonal antibodies to tacrolimus and immunoassays methods for tacrolimus

Compounds are disclosed comprising a moiety, such as a poly(amino acid), a non-poly(amino acid) label moiety, or a non-poly(amino acid) immunogenic carrier, linked to a sirolimus compound at position 26 or at position 32. Such sirolimus compounds comprising an immunogenic carrier can be employed to raise both polyclonal and monoclonal antibodies to the sirolimus compound. Polyclonal antibodies are also disclosed, which are raised against a compound wherein a moiety, such as a poly(amino acid), a non-poly(amino acid) label moiety, or a non-poly(amino acid) immunogenic carrier, is linked to a sirolimus compound at position 32. The above antibodies and sirolimus compounds comprising a label can be used in assays for the detection of sirolimus compounds.

Compositions and methods for detection of sirolimus

Methods, compositions and kits are disclosed. The compounds disclosed comprise an amphetamine moiety and a methamphetamine moiety linked together by a first linking group. A second linking group depends from the first linking group and comprises a functional group. The distance of the amphetamine moiety and the methamphetamine moiety from the point of linkage of the second linking group to the first linking group is approximately the same. The compounds may be linked to labels and used in assays for the detection of amphetamine and/or methamphetamine in samples suspected of containing these drugs.

Assays for amphetamine and methamphetamine

Monoclonal antibodies to tacrolimus and immunoassay methods for tacrolimus

Methods, compositions and kits are disclosed. Enzyme conjugates of Formula I may be employed in assays for the determination of an amphetamine and/or a methamphetamine. Immunogenic conjugates of Formula I may be employed to prepare antibodies for an amphetamine and/or for a methamphetamine for use in assays for the determination of an amphetamine and/or a methamphetamine. The enzyme conjugates may also be employed to screen antibodies for use in such methods.

Assays for amphetamine and methamphetamine using stereospecific reagents

Methods, compositions and kits are disclosed. The methods are directed to determining the presence of entactogen analytes such as, for example, 3,4-methylenedioxyamphetamine (MDA), 3,4-methylenedioxy-methamphetamine (MDMA), 3,4-methylenedioxy-ethylamphetamine (MDEA) and 4-hydroxy-3-methoxy-methamphetamine (HMMA). The method comprises providing in combination in a medium (i) a sample suspected of containing the compound and (ii) an antibody raised against a compound of Formula I that comprises a protein. The medium is examined for the presence a complex comprising the compound and the antibody where the presence of such as complex indicates the presence of the compound in the sample. In one aspect of the above embodiment, the combination further comprises a label conjugate of the compound Formula I.

Assay for entactogens

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Milpitas, CA, United States of America

Hshiou-ting Liu