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  1. Article ; Online: Testing For SARS-CoV-2: The Day the World Turned its Attention to the Clinical Laboratory.

    Zhao, Xuemei / Markensohn, Julia F / Wollensak, David A / Laterza, Omar F

    Clinical and translational science

    2020  Volume 13, Issue 5, Page(s) 871–876

    Abstract: In the last few months, an unprecedented number of laboratory tests for coronavirus disease 2019 (COVID-19) have been developed at a remarkable speed. With the rapid adoption of these tests into clinical practice, combined with the widespread publicity ... ...

    Abstract In the last few months, an unprecedented number of laboratory tests for coronavirus disease 2019 (COVID-19) have been developed at a remarkable speed. With the rapid adoption of these tests into clinical practice, combined with the widespread publicity they received, questions arose related to the different types of tests, their utility, performance, and regulatory approval status. The aim of this publication is to provide a general landscape of laboratory testing for COVID-19 and offer a historical and regulatory perspective associated with them. Specifically, we aim to elaborate on the regulatory complexities of diagnostic testing in the United States and its implications to the present outbreak, as well as provide a synopsis of laboratory tests that have been developed for COVID-19. We will first address the detection of severe acute respiratory syndrome-coronavirus 2 directly by either nucleic acid amplification tests or by the detection of the viral protein for active infections. Subsequently, we will provide an overview of serological tests that can aid not only in diagnosis but additionally help to identify prior infections and potential immunity.
    MeSH term(s) Antibodies, Viral/immunology ; Antibodies, Viral/isolation & purification ; Antigens, Viral/immunology ; Antigens, Viral/isolation & purification ; Betacoronavirus/genetics ; Betacoronavirus/immunology ; Betacoronavirus/isolation & purification ; COVID-19 ; COVID-19 Testing ; Clinical Laboratory Services/legislation & jurisprudence ; Clinical Laboratory Services/organization & administration ; Clinical Laboratory Techniques/methods ; Coronavirus Infections/diagnosis ; Coronavirus Infections/epidemiology ; Coronavirus Infections/transmission ; Coronavirus Infections/virology ; Humans ; Pandemics ; Pneumonia, Viral/diagnosis ; Pneumonia, Viral/epidemiology ; Pneumonia, Viral/transmission ; Pneumonia, Viral/virology ; RNA, Viral/isolation & purification ; SARS-CoV-2 ; Serologic Tests/methods ; United States
    Chemical Substances Antibodies, Viral ; Antigens, Viral ; RNA, Viral
    Keywords covid19
    Language English
    Publishing date 2020-06-29
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2433157-0
    ISSN 1752-8062 ; 1752-8054
    ISSN (online) 1752-8062
    ISSN 1752-8054
    DOI 10.1111/cts.12828
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Testing For SARS-CoV-2: The Day the World Turned its Attention to the Clinical Laboratory

    Zhao, Xuemei / Markensohn, Julia F / Wollensak, David A / Laterza, Omar F

    Clin Transl Sci

    Abstract: In the last few months, an unprecedented number of laboratory tests for coronavirus disease 2019 (COVID-19) have been developed at a remarkable speed. With the rapid adoption of these tests into clinical practice, combined with the widespread publicity ... ...

    Abstract In the last few months, an unprecedented number of laboratory tests for coronavirus disease 2019 (COVID-19) have been developed at a remarkable speed. With the rapid adoption of these tests into clinical practice, combined with the widespread publicity they received, questions arose related to the different types of tests, their utility, performance, and regulatory approval status. The aim of this publication is to provide a general landscape of laboratory testing for COVID-19 and offer a historical and regulatory perspective associated with them. Specifically, we aim to elaborate on the regulatory complexities of diagnostic testing in the United States and its implications to the present outbreak, as well as provide a synopsis of laboratory tests that have been developed for COVID-19. We will first address the detection of severe acute respiratory syndrome-coronavirus 2 directly by either nucleic acid amplification tests or by the detection of the viral protein for active infections. Subsequently, we will provide an overview of serological tests that can aid not only in diagnosis but additionally help to identify prior infections and potential immunity.
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #437063
    Database COVID19

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  3. Article ; Online: Testing For SARS‐CoV‐2

    Zhao, Xuemei / Markensohn, Julia F. / Wollensak, David A. / Laterza, Omar F.

    Clinical and Translational Science ; ISSN 1752-8054 1752-8062

    The Day the World Turned its Attention to the Clinical Laboratory

    2020  

    Keywords General Pharmacology, Toxicology and Pharmaceutics ; General Biochemistry, Genetics and Molecular Biology ; General Neuroscience ; General Medicine ; covid19
    Language English
    Publisher Wiley
    Publishing country us
    Document type Article ; Online
    DOI 10.1111/cts.12828
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: Correction: First-in-Class Anti-Immunoglobulin-like Transcript 4 Myeloid-Specific Antibody MK-4830 Abrogates a PD-1 Resistance Mechanism in Patients with Advanced Solid Tumors.

    Siu, Lillian L / Wang, Ding / Hilton, John / Geva, Ravit / Rasco, Drew / Perets, Ruth / Abraham, Anson K / Wilson, Douglas C / Markensohn, Julia F / Lunceford, Jared / Suttner, Leah / Siddiqi, Shabana / Altura, Rachel A / Maurice-Dror, Corinne

    Clinical cancer research : an official journal of the American Association for Cancer Research

    2022  Volume 28, Issue 8, Page(s) 1734

    Language English
    Publishing date 2022-04-14
    Publishing country United States
    Document type Published Erratum
    ZDB-ID 1225457-5
    ISSN 1557-3265 ; 1078-0432
    ISSN (online) 1557-3265
    ISSN 1078-0432
    DOI 10.1158/1078-0432.CCR-22-0564
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Correction: First-in-Class Anti-immunoglobulin-like Transcript 4 Myeloid-Specific Antibody MK-4830 Abrogates a PD-1 Resistance Mechanism in Patients with Advanced Solid Tumors.

    Siu, Lillian L / Wang, Ding / Hilton, John / Geva, Ravit / Rasco, Drew / Perets, Ruth / Abraham, Anson K / Wilson, Douglas C / Markensohn, Julia F / Lunceford, Jared / Suttner, Leah / Siddiqi, Shabana / Altura, Rachel A / Maurice-Dror, Corinne

    Clinical cancer research : an official journal of the American Association for Cancer Research

    2022  Volume 28, Issue 18, Page(s) 4158

    Language English
    Publishing date 2022-09-15
    Publishing country United States
    Document type Published Erratum
    ZDB-ID 1225457-5
    ISSN 1557-3265 ; 1078-0432
    ISSN (online) 1557-3265
    ISSN 1078-0432
    DOI 10.1158/1078-0432.CCR-22-2320
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: First-in-Class Anti-immunoglobulin-like Transcript 4 Myeloid-Specific Antibody MK-4830 Abrogates a PD-1 Resistance Mechanism in Patients with Advanced Solid Tumors.

    Siu, Lillian L / Wang, Ding / Hilton, John / Geva, Ravit / Rasco, Drew / Perets, Ruth / Abraham, Anson K / Wilson, Douglas C / Markensohn, Julia F / Lunceford, Jared / Suttner, Leah / Siddiqi, Shabana / Altura, Rachel A / Maurice-Dror, Corinne

    Clinical cancer research : an official journal of the American Association for Cancer Research

    2021  Volume 28, Issue 1, Page(s) 57–70

    Abstract: Purpose: In this first-in-human study (NCT03564691) in advanced solid tumors, we investigated a novel first-in-class human IgG4 monoclonal antibody targeting the immunoglobulin-like transcript 4 (ILT4) receptor, MK-4830, as monotherapy and in ... ...

    Abstract Purpose: In this first-in-human study (NCT03564691) in advanced solid tumors, we investigated a novel first-in-class human IgG4 monoclonal antibody targeting the immunoglobulin-like transcript 4 (ILT4) receptor, MK-4830, as monotherapy and in combination with pembrolizumab.
    Patients and methods: Patients with histologically/cytologically confirmed advanced solid tumors, measurable disease by RECIST v1.1, and evaluable baseline tumor sample received escalating doses of intravenous MK-4830 every 3 weeks as monotherapy (parts A and B) and in combination with pembrolizumab (part C). Safety and tolerability were the primary objectives. Pharmacokinetics, objective response rate per RECIST v1.1, and molecular biomarkers were also evaluated.
    Results: Of 84 patients, 50 received monotherapy and 34 received combination therapy. No dose-limiting toxicities were observed; maximum tolerated dose was not reached. MK-4830 showed dose-related target engagement. Eleven of 34 patients in the dose-escalation phase who received combination therapy achieved objective responses; 5 previously had progressive disease on anti-PD-1/PD-L1 therapies. Exploratory evaluation of the association between response and pretreatment gene expression related to interferon-gamma signaling in tumors suggested higher sensitivity to T-cell inflammation with combination therapy than historically expected with pembrolizumab monotherapy, with greater response at more moderate levels of inflammation.
    Conclusions: This first-in-class MK-4830 antibody dosed as monotherapy and in combination with pembrolizumab was well tolerated with no unexpected toxicities, and demonstrated dose-related evidence of target engagement and antitumor activity. Inflammation intrinsic to the ILT4 mechanism may be facilitated by alleviating the myeloid-suppressive components of the tumor microenvironment, supporting the target of ILT4 as a potential novel immunotherapy in combination with an anti-PD-1/PD-L1 agent.
    MeSH term(s) Antibodies, Monoclonal ; Humans ; Maximum Tolerated Dose ; Neoplasms/drug therapy ; Neoplasms/genetics ; Programmed Cell Death 1 Receptor ; Response Evaluation Criteria in Solid Tumors ; Tumor Microenvironment
    Chemical Substances Antibodies, Monoclonal ; Programmed Cell Death 1 Receptor
    Language English
    Publishing date 2021-10-01
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Comment
    ZDB-ID 1225457-5
    ISSN 1557-3265 ; 1078-0432
    ISSN (online) 1557-3265
    ISSN 1078-0432
    DOI 10.1158/1078-0432.CCR-21-2160
    Database MEDical Literature Analysis and Retrieval System OnLINE

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