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    Clinical Evaluation

    Clinical Evaluation: is the assessment and analysis of clinical data pertaining to a medical device in order to verify the clinical safety and performance of the device.

    Webinars

    • FEB 09, 2021 | 8:00 AM
      Endpoint assays for the characterization of rare and therapy-resistant cells in cancer
      Endpoint assays for the characterization of rare and therapy-resistant...
      DATE: February 09, 2021 TIME: 08:00am PST Flow cytometry immunophenotyping has become one of the mainstream applications for the diagnosis and classification of several hematologic neoplasms...
      Speaker: Jordi Petriz
      Sponsored By: Thermo Fisher Scientific
      8
      JAN 21, 2021 | 10:00 AM
      Applications of Procalcitonin-aided Decision Making for Antibiotic Stewardship in Emergency Care
      Applications of Procalcitonin-aided Decision Making for Antibiotic...
      Date: January 21, 2021 Time: 10:00am (PST) Abstract Learning Objectives Discuss Procalcitonin as a biomarker to help distinguish viral versus bacterial infection Review the literature suppor...
      Speaker: Larissa May
      Sponsored By: Thermo Fisher Scientific
      9 1
      DEC 10, 2020 | 8:00 AM
      Simple and Fast Charge Variants Analysis of mAbs by CZE
      Simple and Fast Charge Variants Analysis of mAbs by CZE
      Date: December 10, 2020 Time: 8:00am (PST), 11:00am (EST) As you face increasingly shortened timelines to bring new drugs to market, you find yourself strained to finalize analytical methods...
      Speaker: Yan He, Ph.D.
      Sponsored By: SCIEX
      4 1
      DEC 04, 2020 | 8:00 AM
      Analytical Limitations of HbA1c: Factors to consider when choosing an HbA1c Methodology
      Analytical Limitations of HbA1c: Factors to consider when choosing...
      DATE: December 4th, 2020 TIME: 8:00am PT With many methods available for HbA1c testing, how do you choose a method that’s best for your laboratory? The incidence and prevalence of diab...
      Speaker: Kelly Doyle , Randie Little , David Sacks
      Sponsored By: Sebia, Inc.
      155 1
      DEC 04, 2020 | 5:00 AM
      Hemoglobin A1c: standardization, analytical performance and interference of Hb-variants.
      Hemoglobin A1c: standardization, analytical performance and interference...
      Date: December 04, 2020 Time: 5:00am PDT, 2:00pm CET Diabetes Mellitus has become a worldwide epidemic, affecting approximately 425 million people. Unfortunately, one in two patients remain...
      Speaker: Dr. Erna Lenters-Westra
      Sponsored By: Abbott Diagnostics
      17
      DEC 03, 2020 | 4:30 PM
      An Iterative Approach to Structure-based in silico to in vivo Development of Combinatorial Anti-SARS-CoV-2 Therapy
      An Iterative Approach to Structure-based in silico to in vivo...
      This drug development program is designed to create a family of broad-spectrum, pan-coronaviral drugs that respectively inhibit multiple key enzymes required for viral replication. By target...
      Speaker: Garth Ehrlich, PhD, FAAAS
      Presented at: Coronavirus Series
      5
      DEC 03, 2020 | 10:00 AM
      Keynote Presentation: COVID-19 Projections for the United States
      Keynote Presentation: COVID-19 Projections for the United States
      Cases and deaths continue to increase steadily in most states. The pace of increase is faster than we expected, leading us to revise upward IHME forecast of deaths and cases into the future....
      Speaker: Ali H. Mokdad, PhD
      Presented at: Coronavirus Series
      2
      DEC 03, 2020 | 7:30 AM
      Keynote Presentation: Prevalence of SARS-CoV-2 Immunity in Those Undiagnosed with COVID-19 in the U.S.
      Keynote Presentation: Prevalence of SARS-CoV-2 Immunity in Those...
      Learning Objectives: 1. Define SARS-CoV-2 immunity, antibody testing, and discuss what is known about the meaning of these tests 2. Identify challenges in doing research during social distan...
      Speaker: Matthew J. Memoli, MD, MS
      Presented at: Coronavirus Series
      39 1
      DEC 03, 2020 | 12:00 AM
      COVID-19 RNA and DNA vaccines
      COVID-19 RNA and DNA vaccines
      Learning Objectives: 1. Learn what RNA and DNA vaccines are and why they are ideal vaccine strategies to respond rapidly to pandemics 2. Understand the key requirements of an effective vacci...
      Speaker: Deborah Fuller, PhD
      Presented at: Coronavirus Series
      8
      NOV 18, 2020 | 8:00 AM
      Whole-organ mapping using AI and light sheet microscopy
      Whole-organ mapping using AI and light sheet microscopy
      DATE: November 18, 2020 TIME: 08:00am PDT We develop and implement technologies to solve some of the major bottlenecks in biomedical research. In particular, we establish new imaging approac...
      Speaker: Ali Ertürk
      Sponsored By: Miltenyi Biotec
      14
      November 13, 2020 6:00 PM PST | November 14, 2020 10:00 AM SGT
      Q&A Session (In the RoundTable Room)
      Q&A Session (In the RoundTable Room)
      Visit the RoundTable Room to participate in live Q&A with all the speakers!...
      Speaker: Charalambos C. Solomides, MD , Sara Eglitis, MS, QIHC , Faruk Erdem Kombak, MD , Srabani Bhaumik, PhD , Nelson Alexander, PhD
      Presented at: DISCOVERY Global User Symposium
      0
      November 13, 2020 5:00 PM PST | November 14, 2020 9:00 AM SGT
      Representative sampling to address tumor heterogeneity
      Representative sampling to address tumor heterogeneity
      Ensuring that clinical tests are not affected by tumor heterogeneity requires a sampling methodology that captures the genomic, proteomic, and cellular diversity of entire solid tumors. Howe...
      Speaker: Nelson Alexander, PhD
      Presented at: DISCOVERY Global User Symposium
      2
      November 13, 2020 1:00 PM PST | November 14, 2020 5:00 AM SGT
      Chromogenic multiplex IHC; the future of immunohistochemistry for the practicing pathologist and for research
      Chromogenic multiplex IHC; the future of immunohistochemistry...
      The development of many different chromogens for light microscopy gives us the opportunity to explore different usage of multiplex immunohistochemistry (IHC) for clinical diagnostic purposes...
      Speaker: Charalambos C. Solomides, MD
      Presented at: DISCOVERY Global User Symposium
      0
      NOV 12, 2020 | 1:30 PM
      Covid-19 Testing and the role of Antigen assays today and moving forward
      Covid-19 Testing and the role of Antigen assays today and moving...
      Today's presentation will cover the following topics from the perspective of a NYC based Laboratory: What have we learned year to date about CoV-2 and specifically how diagnostic testing...
      Speaker: Vincent Streva, PhD
      Presented at: Clinical Diagnostics & Research Virtual Event Series 2020
      Sponsored By: Diasorin
      1
      NOV 12, 2020 | 12:00 PM
      Measuring levels of neutralizing antibodies in SARS CoV-2 infected/recovered and vaccinated individuals using a high-throughput and cost-effective test
      Measuring levels of neutralizing antibodies in SARS CoV-2 infected/recovered...
      As many parts of the northern hemisphere move into the colder months and indoors, SARS CoV-2 has begun a second infection wave that has exceeded the first surge of cases in many global regio...
      Speaker: Sean Taylor, MBA, PhD
      Presented at: Clinical Diagnostics & Research Virtual Event Series 2020
      Sponsored By: GenScript
      2
      November 12, 2020 11:00 AM PST | 6:00 PM GMT
      Q&A Session (In the RoundTable Room)
      Q&A Session (In the RoundTable Room)
      Visit the RoundTable Room to participate in live Q&A with all the speakers!...
      Speaker: Charalambos C. Solomides, MD , Sara Eglitis, MS, QIHC , Faruk Erdem Kombak, MD , Srabani Bhaumik, PhD , Nelson Alexander, PhD
      Presented at: DISCOVERY Global User Symposium
      1
      NOV 12, 2020 | 10:30 AM
      Recovery of cfDNA using the QIAsymphony DSP Circulating DNA Kit
      Recovery of cfDNA using the QIAsymphony DSP Circulating DNA Kit
      Cell-free DNA (cfDNA) is a key analyte for liquid biopsy samples. Due to extremely low concentration and high degree of fragmentation, the extraction of cfDNA is technically challenging. Her...
      Speaker: Alexander Wolf, PhD
      Presented at: Clinical Diagnostics & Research Virtual Event Series 2020
      Sponsored By: QIAGEN
      2
      NOV 12, 2020 | 10:00 AM
      FcRn Affinity Column Chromatography for Therapeutic mAb Characterization
      FcRn Affinity Column Chromatography for Therapeutic mAb Characterization
      Date: November 12, 2020 Time: 10:00am (PST), 1:00pm (EST) Fc receptor based affinity chromatography is a new emerging field of Fc functionality analytics. FcRn affinity columns separate anti...
      Speaker: Tilman Schlothauer, Ph.D
      Sponsored By: Roche CustomBiotech
      3
      November 12, 2020 10:00 AM PST | 5:00 PM GMT
      Representative sampling to address tumor heterogeneity
      Representative sampling to address tumor heterogeneity
      Ensuring that clinical tests are not affected by tumor heterogeneity requires a sampling methodology that captures the genomic, proteomic, and cellular diversity of entire solid tumors. Howe...
      Speaker: Nelson Alexander, PhD
      Presented at: DISCOVERY Global User Symposium
      2
      NOV 12, 2020 | 7:30 AM
      Keynote Presentation: Choosing Wisely lab utilization first steps: addressing the low hanging fruit
      Keynote Presentation: Choosing Wisely lab utilization first steps:...
      In 2012, the Choosing Wisely initiative was commenced by the ABIM with numerous societies putting forward lists of overused tests or procedures. The Choosing Wisely movement has spread to nu...
      Speaker: Jeannie Callum, BA, MD, FRCPC
      Presented at: Clinical Diagnostics & Research Virtual Event Series 2020
      1
      November 12, 2020 6:00 AM PST | 1:00 PM GMT
      Chromogenic multiplex IHC; the future of immunohistochemistry for the practicing pathologist and for research
      Chromogenic multiplex IHC; the future of immunohistochemistry...
      The development of many different chromogens for light microscopy gives us the opportunity to explore different usage of multiplex immunohistochemistry (IHC) for clinical diagnostic purposes...
      Speaker: Charalambos C. Solomides, MD
      Presented at: DISCOVERY Global User Symposium
      1
      NOV 10, 2020 | 7:00 AM
      Move Forward with Automation
      Move Forward with Automation
      DATE: November 10, 2020 TIME: 7:00am PDT, 10:00am EDT Automation can provide tremendous benefits such as increased pipetting precision and accuracy, productivity, and throughput. Numerous wo...
      Speaker: Paulina Kocjan , Kirk Mantione, PhD
      Sponsored By: Eppendorf
      15
      NOV 03, 2020 | 5:00 AM
      Evaluation of MICRONAUT-S Anaerobes MIC broth microdilution panels with a large collection of clinical samples
      Evaluation of MICRONAUT-S Anaerobes MIC broth microdilution panels...
      DATE: November 3, 2020 TIME: 6:00am PDT Susceptibility profiles of anaerobes to antimicrobials have become unpredictable, thus reliable and user-friendly methods for routine susceptibility t...
      Speaker: Miriam Cordovana
      Sponsored By: Bruker Microbiology & Infection Diagnostics
      6
      OCT 22, 2020 | 1:35 PM
      Evaluation of the Oncomine Comprehensive Assay Plus for Profiling of Solid Tumours
      Evaluation of the Oncomine Comprehensive Assay Plus for Profiling...
      Precision oncology continues to evolve as additional clinically relevant biomarkers are identified. The challenges facing both diagnostic laboratories and clinicians include not only the abi...
      Speaker: Jane Bayani, PhD
      Presented at: OncomineWorld Autumn: A virtual NGS education meeting
      1
    FEB 09, 2021 | 8:00 AM
    Endpoint assays for the characterization of rare and therapy-resistant cells in cancer
    Endpoint assays for the characterization of rare and therapy-resistant...
    DATE: February 09, 2021 TIME: 08:00am PST Flow cytometry immunophenotyping has become one of the mainstream applications for the diagnosis and classification of several hematologic neoplasms...
    Speaker: Jordi Petriz
    Sponsored By: Thermo Fisher Scientific
    8
    JAN 21, 2021 | 10:00 AM
    Applications of Procalcitonin-aided Decision Making for Antibiotic Stewardship in Emergency Care
    Applications of Procalcitonin-aided Decision Making for Antibiotic...
    Date: January 21, 2021 Time: 10:00am (PST) Abstract Learning Objectives Discuss Procalcitonin as a biomarker to help distinguish viral versus bacterial infection Review the literature suppor...
    Speaker: Larissa May
    Sponsored By: Thermo Fisher Scientific
    9 1
    DEC 10, 2020 | 8:00 AM
    Simple and Fast Charge Variants Analysis of mAbs by CZE
    Simple and Fast Charge Variants Analysis of mAbs by CZE
    Date: December 10, 2020 Time: 8:00am (PST), 11:00am (EST) As you face increasingly shortened timelines to bring new drugs to market, you find yourself strained to finalize analytical methods...
    Speaker: Yan He, Ph.D.
    Sponsored By: SCIEX
    4 1
    DEC 04, 2020 | 8:00 AM
    Analytical Limitations of HbA1c: Factors to consider when choosing an HbA1c Methodology
    Analytical Limitations of HbA1c: Factors to consider when choosing...
    DATE: December 4th, 2020 TIME: 8:00am PT With many methods available for HbA1c testing, how do you choose a method that’s best for your laboratory? The incidence and prevalence of diab...
    Speaker: Kelly Doyle , Randie Little , David Sacks
    Sponsored By: Sebia, Inc.
    155 1
    DEC 04, 2020 | 5:00 AM
    Hemoglobin A1c: standardization, analytical performance and interference of Hb-variants.
    Hemoglobin A1c: standardization, analytical performance and interference...
    Date: December 04, 2020 Time: 5:00am PDT, 2:00pm CET Diabetes Mellitus has become a worldwide epidemic, affecting approximately 425 million people. Unfortunately, one in two patients remain...
    Speaker: Dr. Erna Lenters-Westra
    Sponsored By: Abbott Diagnostics
    17
     
     
  • DEC 03, 2020 | 4:30 PM
    An Iterative Approach to Structure-based in silico to in vivo Development of Combinatorial Anti-SARS-CoV-2 Therapy
    An Iterative Approach to Structure-based in silico to in vivo...
    This drug development program is designed to create a family of broad-spectrum, pan-coronaviral drugs that respectively inhibit multiple key enzymes required for viral replication. By target...
    Speaker: Garth Ehrlich, PhD, FAAAS
    Presented at: Coronavirus Series
    5
    DEC 03, 2020 | 10:00 AM
    Keynote Presentation: COVID-19 Projections for the United States
    Keynote Presentation: COVID-19 Projections for the United States
    Cases and deaths continue to increase steadily in most states. The pace of increase is faster than we expected, leading us to revise upward IHME forecast of deaths and cases into the future....
    Speaker: Ali H. Mokdad, PhD
    Presented at: Coronavirus Series
    2
    DEC 03, 2020 | 7:30 AM
    Keynote Presentation: Prevalence of SARS-CoV-2 Immunity in Those Undiagnosed with COVID-19 in the U.S.
    Keynote Presentation: Prevalence of SARS-CoV-2 Immunity in Those...
    Learning Objectives: 1. Define SARS-CoV-2 immunity, antibody testing, and discuss what is known about the meaning of these tests 2. Identify challenges in doing research during social distan...
    Speaker: Matthew J. Memoli, MD, MS
    Presented at: Coronavirus Series
    39 1
    DEC 03, 2020 | 12:00 AM
    COVID-19 RNA and DNA vaccines
    COVID-19 RNA and DNA vaccines
    Learning Objectives: 1. Learn what RNA and DNA vaccines are and why they are ideal vaccine strategies to respond rapidly to pandemics 2. Understand the key requirements of an effective vacci...
    Speaker: Deborah Fuller, PhD
    Presented at: Coronavirus Series
    8
    NOV 18, 2020 | 8:00 AM
    Whole-organ mapping using AI and light sheet microscopy
    Whole-organ mapping using AI and light sheet microscopy
    DATE: November 18, 2020 TIME: 08:00am PDT We develop and implement technologies to solve some of the major bottlenecks in biomedical research. In particular, we establish new imaging approac...
    Speaker: Ali Ertürk
    Sponsored By: Miltenyi Biotec
    14
     
     
  • November 13, 2020 6:00 PM PST | November 14, 2020 10:00 AM SGT
    Q&A Session (In the RoundTable Room)
    Q&A Session (In the RoundTable Room)
    Visit the RoundTable Room to participate in live Q&A with all the speakers!...
    Speaker: Charalambos C. Solomides, MD , Sara Eglitis, MS, QIHC , Faruk Erdem Kombak, MD , Srabani Bhaumik, PhD , Nelson Alexander, PhD
    Presented at: DISCOVERY Global User Symposium
    0
    November 13, 2020 5:00 PM PST | November 14, 2020 9:00 AM SGT
    Representative sampling to address tumor heterogeneity
    Representative sampling to address tumor heterogeneity
    Ensuring that clinical tests are not affected by tumor heterogeneity requires a sampling methodology that captures the genomic, proteomic, and cellular diversity of entire solid tumors. Howe...
    Speaker: Nelson Alexander, PhD
    Presented at: DISCOVERY Global User Symposium
    2
    November 13, 2020 1:00 PM PST | November 14, 2020 5:00 AM SGT
    Chromogenic multiplex IHC; the future of immunohistochemistry for the practicing pathologist and for research
    Chromogenic multiplex IHC; the future of immunohistochemistry...
    The development of many different chromogens for light microscopy gives us the opportunity to explore different usage of multiplex immunohistochemistry (IHC) for clinical diagnostic purposes...
    Speaker: Charalambos C. Solomides, MD
    Presented at: DISCOVERY Global User Symposium
    0
    NOV 12, 2020 | 1:30 PM
    Covid-19 Testing and the role of Antigen assays today and moving forward
    Covid-19 Testing and the role of Antigen assays today and moving...
    Today's presentation will cover the following topics from the perspective of a NYC based Laboratory: What have we learned year to date about CoV-2 and specifically how diagnostic testing...
    Speaker: Vincent Streva, PhD
    Presented at: Clinical Diagnostics & Research Virtual Event Series 2020
    Sponsored By: Diasorin
    1
    NOV 12, 2020 | 12:00 PM
    Measuring levels of neutralizing antibodies in SARS CoV-2 infected/recovered and vaccinated individuals using a high-throughput and cost-effective test
    Measuring levels of neutralizing antibodies in SARS CoV-2 infected/recovered...
    As many parts of the northern hemisphere move into the colder months and indoors, SARS CoV-2 has begun a second infection wave that has exceeded the first surge of cases in many global regio...
    Speaker: Sean Taylor, MBA, PhD
    Presented at: Clinical Diagnostics & Research Virtual Event Series 2020
    Sponsored By: GenScript
    2
     
     
  • November 12, 2020 11:00 AM PST | 6:00 PM GMT
    Q&A Session (In the RoundTable Room)
    Q&A Session (In the RoundTable Room)
    Visit the RoundTable Room to participate in live Q&A with all the speakers!...
    Speaker: Charalambos C. Solomides, MD , Sara Eglitis, MS, QIHC , Faruk Erdem Kombak, MD , Srabani Bhaumik, PhD , Nelson Alexander, PhD
    Presented at: DISCOVERY Global User Symposium
    1
    NOV 12, 2020 | 10:30 AM
    Recovery of cfDNA using the QIAsymphony DSP Circulating DNA Kit
    Recovery of cfDNA using the QIAsymphony DSP Circulating DNA Kit
    Cell-free DNA (cfDNA) is a key analyte for liquid biopsy samples. Due to extremely low concentration and high degree of fragmentation, the extraction of cfDNA is technically challenging. Her...
    Speaker: Alexander Wolf, PhD
    Presented at: Clinical Diagnostics & Research Virtual Event Series 2020
    Sponsored By: QIAGEN
    2
    NOV 12, 2020 | 10:00 AM
    FcRn Affinity Column Chromatography for Therapeutic mAb Characterization
    FcRn Affinity Column Chromatography for Therapeutic mAb Characterization
    Date: November 12, 2020 Time: 10:00am (PST), 1:00pm (EST) Fc receptor based affinity chromatography is a new emerging field of Fc functionality analytics. FcRn affinity columns separate anti...
    Speaker: Tilman Schlothauer, Ph.D
    Sponsored By: Roche CustomBiotech
    3
    November 12, 2020 10:00 AM PST | 5:00 PM GMT
    Representative sampling to address tumor heterogeneity
    Representative sampling to address tumor heterogeneity
    Ensuring that clinical tests are not affected by tumor heterogeneity requires a sampling methodology that captures the genomic, proteomic, and cellular diversity of entire solid tumors. Howe...
    Speaker: Nelson Alexander, PhD
    Presented at: DISCOVERY Global User Symposium
    2
    NOV 12, 2020 | 7:30 AM
    Keynote Presentation: Choosing Wisely lab utilization first steps: addressing the low hanging fruit
    Keynote Presentation: Choosing Wisely lab utilization first steps:...
    In 2012, the Choosing Wisely initiative was commenced by the ABIM with numerous societies putting forward lists of overused tests or procedures. The Choosing Wisely movement has spread to nu...
    Speaker: Jeannie Callum, BA, MD, FRCPC
    Presented at: Clinical Diagnostics & Research Virtual Event Series 2020
    1
     
     
  • November 12, 2020 6:00 AM PST | 1:00 PM GMT
    Chromogenic multiplex IHC; the future of immunohistochemistry for the practicing pathologist and for research
    Chromogenic multiplex IHC; the future of immunohistochemistry...
    The development of many different chromogens for light microscopy gives us the opportunity to explore different usage of multiplex immunohistochemistry (IHC) for clinical diagnostic purposes...
    Speaker: Charalambos C. Solomides, MD
    Presented at: DISCOVERY Global User Symposium
    1
    NOV 10, 2020 | 7:00 AM
    Move Forward with Automation
    Move Forward with Automation
    DATE: November 10, 2020 TIME: 7:00am PDT, 10:00am EDT Automation can provide tremendous benefits such as increased pipetting precision and accuracy, productivity, and throughput. Numerous wo...
    Speaker: Paulina Kocjan , Kirk Mantione, PhD
    Sponsored By: Eppendorf
    15
    NOV 03, 2020 | 5:00 AM
    Evaluation of MICRONAUT-S Anaerobes MIC broth microdilution panels with a large collection of clinical samples
    Evaluation of MICRONAUT-S Anaerobes MIC broth microdilution panels...
    DATE: November 3, 2020 TIME: 6:00am PDT Susceptibility profiles of anaerobes to antimicrobials have become unpredictable, thus reliable and user-friendly methods for routine susceptibility t...
    Speaker: Miriam Cordovana
    Sponsored By: Bruker Microbiology & Infection Diagnostics
    6
    OCT 22, 2020 | 1:35 PM
    Evaluation of the Oncomine Comprehensive Assay Plus for Profiling of Solid Tumours
    Evaluation of the Oncomine Comprehensive Assay Plus for Profiling...
    Precision oncology continues to evolve as additional clinically relevant biomarkers are identified. The challenges facing both diagnostic laboratories and clinicians include not only the abi...
    Speaker: Jane Bayani, PhD
    Presented at: OncomineWorld Autumn: A virtual NGS education meeting
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