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    CLIA

    CLIA: (Clinical Laboratory Improvement Amendments) are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research.

    Webinars

    • APR 10, 2019 | 1:30 PM
      Laboratory Medicine Beyond The Box: Value Based Health Care & Diagnostic Evidence
      Laboratory Medicine Beyond The Box: Value Based Health Care &...
      Integration of technology is influencing practice in the clinical laboratory and treatment of patients in the clinical practice arena. As laboratories begin to move from a volume to value mod...
      Speaker: Elizabeth Marlowe, PhD, D(ABMM) , Joanna Sickler, MPH, MBA
      Presented at: Molecular Diagnostics Virtual Event Series 2019
      4
      APR 10, 2019 | 12:00 PM
      Best Practices for Implementing NGS and Positioning for Future Growth: Perspectives from 2 Labs
      Best Practices for Implementing NGS and Positioning for Future...
      Personalized medicine driven by genomic-based treatments continues to increase in importance. Representatives from two distinct healthcare entities – a regional reference lab and commun...
      Speaker: Tony Magliocco, MD , Keith Gligorich, PhD
      Presented at: Molecular Diagnostics Virtual Event Series 2019
      Sponsored By: Illumina
      7
      APR 10, 2019 | 9:00 AM
      Validation and Implementation of Quantitative Molecular Assays
      Validation and Implementation of Quantitative Molecular Assays
      Regulatory requirements for verification and validation are complex and often cause confusion among clinical laboratorians, especially in regards to quantitative molecular assays. This presen...
      Speaker: Morgan Pence, PhD, D(ABMM)
      Presented at: Molecular Diagnostics Virtual Event Series 2019
      Sponsored By: Diasorin
      8
      FEB 05, 2019 | 9:00 AM
      Complimentary Webinar: Data Privacy and Other Clinical Data Management Challenges
      Complimentary Webinar: Data Privacy and Other Clinical Data Management...
      DATE:  February 5, 2019TIME:  9:00am PST, 12:00pm EST CloudLIMS.com is pleased to invite you to attend a complimentary webinar. The webinar focuses on the importa...
      Speaker: Marianne Henderson
      Sponsored By: CloudLIMS
      9
      SEP 19, 2018 | 6:00 AM
      Quality Assurance in the Hematology Laboratory
      Quality Assurance in the Hematology Laboratory
      DATE: September 19,2018TIME: 06:00am PDT, 09:00am EDT Statistical Quality Control is well established as a key assurance technique for medical laboratories. In chemistry and...
      Speaker: Sten Westgard, MS
      Sponsored By: Abbott
      41 7
      JUN 20, 2018 | 7:30 AM
      Keynote Presentation: Supporting Precision Medicine and Clinical Research at Scale - Challenges and Opportunities
      Keynote Presentation: Supporting Precision Medicine and Clinical...
      Precision medicine based on molecular profiling is moving from the realm of clinical utility studies towards standard of care. There remain, however, significant technological and implementat...
      Speaker: Niall Lennon, PhD
      Presented at: Precision Medicine Virtual Event Series 2018
      1
      MAY 09, 2018 | 1:30 PM
      Next-Generation Sequencing to Understand the Function of miRNAs in Human IPSC-Cardiomyocyte Disease Models
      Next-Generation Sequencing to Understand the Function of miRNAs...
      There is increasing evidence that intracellular miRNAs play a role in the pathogenesis of many complex disease phenotypes.  In addition, extracellular miRNAs in exosomes are emerging as...
      Speaker: Ulrich Broeckel, MD , Amy Turner, BS
      Presented at: Genetics and Genomics Virtual Event Series 2018
      Sponsored By: QIAGEN
      1
      APR 12, 2018 | 6:00 AM
      Polypharmacy: A Healthcare Dilemma with a Genomic Medicine Solution
      Polypharmacy: A Healthcare Dilemma with a Genomic Medicine Solution
      Polypharmacy, the simultaneous use of multiple medications, is growing at an alarming rate with reports documenting a range of 12 to 22 prescriptions being used on average by individuals >...
      Speaker: Roland Valdes Jr., PhD, DABCC, FACC
      Presented at: Molecular Diagnostics Virtual Event Series 2018
      1
      APR 11, 2018 | 1:30 PM
      Community Pharmacy-Based Disease Management Programs Using Point-of-Care Tests
      Community Pharmacy-Based Disease Management Programs Using Point-of-Care...
      The availability of CLIA-waived point-of-care tests and the accessibility and training of community pharmacists creates an opportunity for the development of collaborative disease management...
      Speaker: Donald Klepser, PhD
      Presented at: Molecular Diagnostics Virtual Event Series 2018
      1
      DEC 14, 2017 | 8:00 AM
      WEBINAR: Emergence of Clinical Proteomics: Identifying and developing actionable protein biomarkers for use in clinical research.
      WEBINAR: Emergence of Clinical Proteomics: Identifying and developing...
      DATE: December 14, 2017TIME: 08:00am PST, 11:00am EST, 4:00pm BST, 5:00pm CESTThe benefits of genomic analysis are well understood, however, the majority of patients do not harbor drugg...
      Speaker: Todd Hembrough, PhD , Maryann Vogelsang, PhD
      Sponsored By: Thermo Fisher Scientific
      5
      DEC 05, 2017 | 8:00 AM
      WEBINAR:  The Future of Syphilis Testing: Improve your workflow with novel technologies
      WEBINAR: The Future of Syphilis Testing: Improve your workflow...
      DATE: December 5, 2017TIME: 08:00am PST, 10:00am CST, 11:00am EST, 5:00pm CET Recently there has been a resurgence of Syphilis infections over the last several years with rates...
      Speaker: Belinda Yen-Lieberman, PhD, MS , Alan Wu, PhD. D.A.B.C.C. , Vera Tesic, MD, MS, D (ABMM), M (ASCP)
      Sponsored By: Bio-Rad Laboratories
      9 3
      NOV 09, 2017 | 1:30 PM
      The Development and Commercialization of Robust Circulating DNA and RNA Tests
      The Development and Commercialization of Robust Circulating DNA...
      The GeneStrat® Genomic Test is a blood-based series of ddPCR tests for DNA (EGFR, KRAS, BRAF) and multiplexed assays for RNA variants (EML4-ALK, ROS1, RET).  In this report we will u...
      Speaker: Hestia Mellert, PhD
      Presented at: Clinical Diagnostics & Research Virtual Event Series 2017
      1
      SEP 14, 2017 | 10:30 AM
      Clinical and Laboratory Studies of Zika Virus Infection
      Clinical and Laboratory Studies of Zika Virus Infection
      An unbiased metagenomic next-generation approach (mNGS) been shown to be useful in the broad identification of pathogens in clinical samples for infectious disease diagnosis, including viruse...
      Speaker: Charles Chiu, MD, PhD
      Presented at: Microbiology & Immunology Virtual Event Series 2017
      2
      JUN 27, 2017 | 8:00 AM
      WEBINAR: Investigating the Genetics of Human Macrophage Response and Resistance to Mycobacterium tuberculosis with AmpliSeqâ„¢ Gene Expression Panels
      WEBINAR: Investigating the Genetics of Human Macrophage Response...
      DATE: June 27, 2017TIME: 8:00am PT, 11:00am ETThe purpose of this study is to identify genetic variants that influence cellular responses, and patterns of M.tb infection and growth in h...
      Speaker: Audrey Papp, B.S., MT ASCP(H), CLSp MB
      Sponsored By: Thermo Fisher Scientific - Ion Torrent
      3 1
      APR 12, 2017 | 1:30 PM
      Perspectives for Whole Cell Microbial Reference Materials
      Perspectives for Whole Cell Microbial Reference Materials
      With the exception of the Microbiome Quality Control (MBQC), very little has been published on best practices and reference standards for microbiome and metagenomic studies. As evidenced by r...
      Speaker: J. Russ Carmical, PhD
      Presented at: Molecular Diagnostics Virtual Event Series 2017
      2
      FEB 23, 2017 | 6:00 AM
      Validation and Commercialization of Liquid Biopsy in a CLIA Lab
      Validation and Commercialization of Liquid Biopsy in a CLIA Lab
      Liquid Biopsies are gaining acceptance in the Oncology community as a surrogate or complement to the gold standard of tissue biopsy.  A liquid biopsy provides biomarker information that...
      Speaker: Michael Nall
      Presented at: Precision Medicine Virtual Event Series 2017
      2
      DEC 06, 2016 | 8:00 AM
      Pre-emptive genotyping for pharmacogenomic risk - establishing a benchmark
      Pre-emptive genotyping for pharmacogenomic risk - establishing...
      DATE: December 6, 2016 TIME: 8:00am PT, 11:00am ET Adverse drug reactions (ADRs) are one of the leading causes of morbidity and mortality in health care. In the US alone, an est...
      Speaker: Ulrich Broeckel, MD
      Sponsored By: Affymetrix, Affymetrix
      6
      NOV 02, 2016 | 7:30 AM
      FDA and Mass Spec Tests for Clinical Labs
      FDA and Mass Spec Tests for Clinical Labs
      Most of the tests performed for patient care use automated colorimetric and immunoassay methods in the clinical laboratories. Clinical labs are regulated by CLIA and are routinely inspected b...
      Speaker: Ravinder Singh, PhD
      Presented at: Clinical Diagnostics & Research Virtual Event Series 2016
      3
      JUN 08, 2016 | 12:30 PM
      Laboratory reimbursement and other regulatory issues
      Laboratory reimbursement and other regulatory issues
      The Centers for Medicare and Medicaid Services (CMS) is about to gather reimbursement data from laboratories to recalculate the clinical laboratory fee schedule.  The process and potenti...
      Speaker: Elissa Passiment
      Presented at: A Virtual Destination for Laboratory Professionals
      Sponsored By: Cardinal Healthâ„¢ OptiFreight® Logistics, American Society for Clinical Laboratory Science (ASCLS)
      5
      NOV 11, 2015 | 1:30 PM
      Why to validate diagnostic tests?
      Why to validate diagnostic tests?
      This lecture will provide attendees with the knowledge and skills to bring on new clinical laboratory tests in clinical chemistry and molecular diagnostics. The lecture will provide a general...
      Speaker: Wieslaw Furmaga, MD
      Presented at: Clinical Diagnostics & Research Virtual Event Series 2015
      4
      NOV 11, 2015 | 6:00 AM
      A Comprehensive Toxicology Screening Solution Targeted to Individual Needs
      A Comprehensive Toxicology Screening Solution Targeted to Individual...
      Drugs of abuse toxicology testing by immunoassays is widely used clinically, but also known to be inadequate for many clinical indications. In this presentation, the speaker will outline diff...
      Speaker: Ping Wang, PhD, DABCC, FACB
      Presented at: Clinical Diagnostics & Research Virtual Event Series 2015
      3
      OCT 30, 2014 | 9:00 AM
      A head-to-head comparison of whole blood derived samples (cfDNA vs CTC DNA) for cancer research using next-generation sequencing
      A head-to-head comparison of whole blood derived samples (cfDNA...
      Both cell free DNA (cfDNA) and circulating tumor cells (CTC) represent important possible templates for mutation analysis of clinical samples. Each template has different theoretical advantag...
      Speaker: Paul W. Dempsey, PhD
      Presented at: Cancer: Research, Discovery and Therapeutics Virtual Event Series 2014
      0
      OCT 29, 2014 | 3:00 PM
      Drug-tailored, efficacy-predictive and prognostic biomarker approaches for proper patient selection
      Drug-tailored, efficacy-predictive and prognostic biomarker approaches...
      Over the last decade we have witnessed tremendous advances in our understanding of the underlying molecular alterations in human cancer. This has stimulated excitement for our ability to deve...
      Speaker: Peter Blume-Jensen, MD, PhD
      Presented at: Cancer: Research, Discovery and Therapeutics Virtual Event Series 2014
      0
      AUG 20, 2014 | 10:45 AM
      OncoScan Assay for copy number from FFPE. Publications & cases on actionable CNV detection
      OncoScan Assay for copy number from FFPE. Publications & cases...
      A recent publication in Nature Genetics1 analyzed TCGA data, and classified solid tumors into two mutually exclusive classes: C class tumors, driven by copy number alterations; and M class tu...
      Speaker: Padma Sundar, MBA, MPH
      Presented at: Genetics and Genomics Virtual Event Series 2014
      14
    APR 10, 2019 | 1:30 PM
    Laboratory Medicine Beyond The Box: Value Based Health Care & Diagnostic Evidence
    Laboratory Medicine Beyond The Box: Value Based Health Care &...
    Integration of technology is influencing practice in the clinical laboratory and treatment of patients in the clinical practice arena. As laboratories begin to move from a volume to value mod...
    Speaker: Elizabeth Marlowe, PhD, D(ABMM) , Joanna Sickler, MPH, MBA
    Presented at: Molecular Diagnostics Virtual Event Series 2019
    4
    APR 10, 2019 | 12:00 PM
    Best Practices for Implementing NGS and Positioning for Future Growth: Perspectives from 2 Labs
    Best Practices for Implementing NGS and Positioning for Future...
    Personalized medicine driven by genomic-based treatments continues to increase in importance. Representatives from two distinct healthcare entities – a regional reference lab and commun...
    Speaker: Tony Magliocco, MD , Keith Gligorich, PhD
    Presented at: Molecular Diagnostics Virtual Event Series 2019
    Sponsored By: Illumina
    7
    APR 10, 2019 | 9:00 AM
    Validation and Implementation of Quantitative Molecular Assays
    Validation and Implementation of Quantitative Molecular Assays
    Regulatory requirements for verification and validation are complex and often cause confusion among clinical laboratorians, especially in regards to quantitative molecular assays. This presen...
    Speaker: Morgan Pence, PhD, D(ABMM)
    Presented at: Molecular Diagnostics Virtual Event Series 2019
    Sponsored By: Diasorin
    8
    FEB 05, 2019 | 9:00 AM
    Complimentary Webinar: Data Privacy and Other Clinical Data Management Challenges
    Complimentary Webinar: Data Privacy and Other Clinical Data Management...
    DATE:  February 5, 2019TIME:  9:00am PST, 12:00pm EST CloudLIMS.com is pleased to invite you to attend a complimentary webinar. The webinar focuses on the importa...
    Speaker: Marianne Henderson
    Sponsored By: CloudLIMS
    9
    SEP 19, 2018 | 6:00 AM
    Quality Assurance in the Hematology Laboratory
    Quality Assurance in the Hematology Laboratory
    DATE: September 19,2018TIME: 06:00am PDT, 09:00am EDT Statistical Quality Control is well established as a key assurance technique for medical laboratories. In chemistry and...
    Speaker: Sten Westgard, MS
    Sponsored By: Abbott
    41 7
     
     
  • JUN 20, 2018 | 7:30 AM
    Keynote Presentation: Supporting Precision Medicine and Clinical Research at Scale - Challenges and Opportunities
    Keynote Presentation: Supporting Precision Medicine and Clinical...
    Precision medicine based on molecular profiling is moving from the realm of clinical utility studies towards standard of care. There remain, however, significant technological and implementat...
    Speaker: Niall Lennon, PhD
    Presented at: Precision Medicine Virtual Event Series 2018
    1
    MAY 09, 2018 | 1:30 PM
    Next-Generation Sequencing to Understand the Function of miRNAs in Human IPSC-Cardiomyocyte Disease Models
    Next-Generation Sequencing to Understand the Function of miRNAs...
    There is increasing evidence that intracellular miRNAs play a role in the pathogenesis of many complex disease phenotypes.  In addition, extracellular miRNAs in exosomes are emerging as...
    Speaker: Ulrich Broeckel, MD , Amy Turner, BS
    Presented at: Genetics and Genomics Virtual Event Series 2018
    Sponsored By: QIAGEN
    1
    APR 12, 2018 | 6:00 AM
    Polypharmacy: A Healthcare Dilemma with a Genomic Medicine Solution
    Polypharmacy: A Healthcare Dilemma with a Genomic Medicine Solution
    Polypharmacy, the simultaneous use of multiple medications, is growing at an alarming rate with reports documenting a range of 12 to 22 prescriptions being used on average by individuals >...
    Speaker: Roland Valdes Jr., PhD, DABCC, FACC
    Presented at: Molecular Diagnostics Virtual Event Series 2018
    1
    APR 11, 2018 | 1:30 PM
    Community Pharmacy-Based Disease Management Programs Using Point-of-Care Tests
    Community Pharmacy-Based Disease Management Programs Using Point-of-Care...
    The availability of CLIA-waived point-of-care tests and the accessibility and training of community pharmacists creates an opportunity for the development of collaborative disease management...
    Speaker: Donald Klepser, PhD
    Presented at: Molecular Diagnostics Virtual Event Series 2018
    1
    DEC 14, 2017 | 8:00 AM
    WEBINAR: Emergence of Clinical Proteomics: Identifying and developing actionable protein biomarkers for use in clinical research.
    WEBINAR: Emergence of Clinical Proteomics: Identifying and developing...
    DATE: December 14, 2017TIME: 08:00am PST, 11:00am EST, 4:00pm BST, 5:00pm CESTThe benefits of genomic analysis are well understood, however, the majority of patients do not harbor drugg...
    Speaker: Todd Hembrough, PhD , Maryann Vogelsang, PhD
    Sponsored By: Thermo Fisher Scientific
    5
     
     
  • DEC 05, 2017 | 8:00 AM
    WEBINAR:  The Future of Syphilis Testing: Improve your workflow with novel technologies
    WEBINAR: The Future of Syphilis Testing: Improve your workflow...
    DATE: December 5, 2017TIME: 08:00am PST, 10:00am CST, 11:00am EST, 5:00pm CET Recently there has been a resurgence of Syphilis infections over the last several years with rates...
    Speaker: Belinda Yen-Lieberman, PhD, MS , Alan Wu, PhD. D.A.B.C.C. , Vera Tesic, MD, MS, D (ABMM), M (ASCP)
    Sponsored By: Bio-Rad Laboratories
    9 3
    NOV 09, 2017 | 1:30 PM
    The Development and Commercialization of Robust Circulating DNA and RNA Tests
    The Development and Commercialization of Robust Circulating DNA...
    The GeneStrat® Genomic Test is a blood-based series of ddPCR tests for DNA (EGFR, KRAS, BRAF) and multiplexed assays for RNA variants (EML4-ALK, ROS1, RET).  In this report we will u...
    Speaker: Hestia Mellert, PhD
    Presented at: Clinical Diagnostics & Research Virtual Event Series 2017
    1
    SEP 14, 2017 | 10:30 AM
    Clinical and Laboratory Studies of Zika Virus Infection
    Clinical and Laboratory Studies of Zika Virus Infection
    An unbiased metagenomic next-generation approach (mNGS) been shown to be useful in the broad identification of pathogens in clinical samples for infectious disease diagnosis, including viruse...
    Speaker: Charles Chiu, MD, PhD
    Presented at: Microbiology & Immunology Virtual Event Series 2017
    2
    JUN 27, 2017 | 8:00 AM
    WEBINAR: Investigating the Genetics of Human Macrophage Response and Resistance to Mycobacterium tuberculosis with AmpliSeqâ„¢ Gene Expression Panels
    WEBINAR: Investigating the Genetics of Human Macrophage Response...
    DATE: June 27, 2017TIME: 8:00am PT, 11:00am ETThe purpose of this study is to identify genetic variants that influence cellular responses, and patterns of M.tb infection and growth in h...
    Speaker: Audrey Papp, B.S., MT ASCP(H), CLSp MB
    Sponsored By: Thermo Fisher Scientific - Ion Torrent
    3 1
    APR 12, 2017 | 1:30 PM
    Perspectives for Whole Cell Microbial Reference Materials
    Perspectives for Whole Cell Microbial Reference Materials
    With the exception of the Microbiome Quality Control (MBQC), very little has been published on best practices and reference standards for microbiome and metagenomic studies. As evidenced by r...
    Speaker: J. Russ Carmical, PhD
    Presented at: Molecular Diagnostics Virtual Event Series 2017
    2
     
     
  • FEB 23, 2017 | 6:00 AM
    Validation and Commercialization of Liquid Biopsy in a CLIA Lab
    Validation and Commercialization of Liquid Biopsy in a CLIA Lab
    Liquid Biopsies are gaining acceptance in the Oncology community as a surrogate or complement to the gold standard of tissue biopsy.  A liquid biopsy provides biomarker information that...
    Speaker: Michael Nall
    Presented at: Precision Medicine Virtual Event Series 2017
    2
    DEC 06, 2016 | 8:00 AM
    Pre-emptive genotyping for pharmacogenomic risk - establishing a benchmark
    Pre-emptive genotyping for pharmacogenomic risk - establishing...
    DATE: December 6, 2016 TIME: 8:00am PT, 11:00am ET Adverse drug reactions (ADRs) are one of the leading causes of morbidity and mortality in health care. In the US alone, an est...
    Speaker: Ulrich Broeckel, MD
    Sponsored By: Affymetrix, Affymetrix
    6
    NOV 02, 2016 | 7:30 AM
    FDA and Mass Spec Tests for Clinical Labs
    FDA and Mass Spec Tests for Clinical Labs
    Most of the tests performed for patient care use automated colorimetric and immunoassay methods in the clinical laboratories. Clinical labs are regulated by CLIA and are routinely inspected b...
    Speaker: Ravinder Singh, PhD
    Presented at: Clinical Diagnostics & Research Virtual Event Series 2016
    3
    JUN 08, 2016 | 12:30 PM
    Laboratory reimbursement and other regulatory issues
    Laboratory reimbursement and other regulatory issues
    The Centers for Medicare and Medicaid Services (CMS) is about to gather reimbursement data from laboratories to recalculate the clinical laboratory fee schedule.  The process and potenti...
    Speaker: Elissa Passiment
    Presented at: A Virtual Destination for Laboratory Professionals
    Sponsored By: Cardinal Healthâ„¢ OptiFreight® Logistics, American Society for Clinical Laboratory Science (ASCLS)
    5
    NOV 11, 2015 | 1:30 PM
    Why to validate diagnostic tests?
    Why to validate diagnostic tests?
    This lecture will provide attendees with the knowledge and skills to bring on new clinical laboratory tests in clinical chemistry and molecular diagnostics. The lecture will provide a general...
    Speaker: Wieslaw Furmaga, MD
    Presented at: Clinical Diagnostics & Research Virtual Event Series 2015
    4
     
     
  • NOV 11, 2015 | 6:00 AM
    A Comprehensive Toxicology Screening Solution Targeted to Individual Needs
    A Comprehensive Toxicology Screening Solution Targeted to Individual...
    Drugs of abuse toxicology testing by immunoassays is widely used clinically, but also known to be inadequate for many clinical indications. In this presentation, the speaker will outline diff...
    Speaker: Ping Wang, PhD, DABCC, FACB
    Presented at: Clinical Diagnostics & Research Virtual Event Series 2015
    3
    OCT 30, 2014 | 9:00 AM
    A head-to-head comparison of whole blood derived samples (cfDNA vs CTC DNA) for cancer research using next-generation sequencing
    A head-to-head comparison of whole blood derived samples (cfDNA...
    Both cell free DNA (cfDNA) and circulating tumor cells (CTC) represent important possible templates for mutation analysis of clinical samples. Each template has different theoretical advantag...
    Speaker: Paul W. Dempsey, PhD
    Presented at: Cancer: Research, Discovery and Therapeutics Virtual Event Series 2014
    0
    OCT 29, 2014 | 3:00 PM
    Drug-tailored, efficacy-predictive and prognostic biomarker approaches for proper patient selection
    Drug-tailored, efficacy-predictive and prognostic biomarker approaches...
    Over the last decade we have witnessed tremendous advances in our understanding of the underlying molecular alterations in human cancer. This has stimulated excitement for our ability to deve...
    Speaker: Peter Blume-Jensen, MD, PhD
    Presented at: Cancer: Research, Discovery and Therapeutics Virtual Event Series 2014
    0
    AUG 20, 2014 | 10:45 AM
    OncoScan Assay for copy number from FFPE. Publications & cases on actionable CNV detection
    OncoScan Assay for copy number from FFPE. Publications & cases...
    A recent publication in Nature Genetics1 analyzed TCGA data, and classified solid tumors into two mutually exclusive classes: C class tumors, driven by copy number alterations; and M class tu...
    Speaker: Padma Sundar, MBA, MPH
    Presented at: Genetics and Genomics Virtual Event Series 2014
    14
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