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    Scientific Posters

    Browse our collection of key opinion leader driven content, presented at industry conferences and webinar sessions.

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    Development of Matched Maternal-Fetal NIPT Reference Materials

    NIPT

    Development of Matched Maternal-Fetal NIPT Reference Materials

    How to assure quality of NIPT tests and concordance of test results between various platforms  limited availability of clinical samples which can be used for proficiency testing, assay validations, and run controls? 

    DNA

    DNA

    Development of Quality Control Reference Materials for MSI Testing

    Microsatellite Instability (MSI) occurs in cancer cells when there is deficient DNA mismatch repair.

    TMB

    TMB

    Development and performance of formalin-damaged FFPE reference materials

    FFPE reference materials that closely mimic the damage profile of cancer patient samples are difficult to design, manufacture and/or source. We have developed an FFPE manufacturing process for reference materials...

    TMB

    TMB

    Reference Materials for Measurable Residual Disease (MRD) Monitoring in Circulating Cell-Free DNA

    Presented at AMP 2020, this poster describes RMs for the development, validation, and control of MRD assays. We designed our RMs for...

    bTMB

    bTMB

    Development and validation of blood tumor mutational burden reference standards

    We announced the availability of a range of human diseased cell line based Seraseq® Blood TMB (bTMB) reference controls to support the validation and precise measurements of plasma-derived blood tumor mutational burden...

    TMB

    TMB

    Development and performance of a formalin-damaged multiplexed DNA tumor mutation FFPE reference material

    FFPE reference materials that closely mimic the damage profile of cancer patient samples are difficult to design, manufacture and/or source. We have developed an FFPE manufacturing process for reference materials...

    TMB

    TMB

    Development of reference material for blood tumor mutational burden measurement

    Although most TMB measurements are made from genomic DNA that has been extracted from formalin-fixed paraffin embedded tissue sections, some diagnostic tests attempt to measure TMB in circulating tumor DNA (ctDNA) extracted from blood samples; an approach referred to as blood TMB (bTMB).

    TMB

    TMB

    Reference Materials for Measurable Residual Disease (MRD) Monitoring

    The analytical validation of liquid biopsy-based assays that attempt to monitor for the disappearance and reemergence of cancer can be challenging due to the need for reference materials...

    NGS

    NGS

    NGS-based Reference Materials for Fusion and Somatic Variant Detection in Myeloid Cancers

    The large range of genetic aberrations and genes involved in Myelogenous malignancies and clonal diseases of hematopoietic progenitor cells which can lead to accumulation of immature blast cells...

    NIPT

    NIPT

    Development of SNP Matched NIPT Reference Materials for Validation, Proficiency Testing and Quality Control

    Plasma based non invasive prenatal testing (NIPT) by Next Generation Sequencing (NGS) is being adopted into clinical laboratories. However, obtaining sufficient amounts of patient derived reference materials for...

    TMB

    TMB

    Improving and Standardizing TMB Assay Performance

    Determining and using the most effective and safest treatment is of great importance in cancer disease management. Recently, a potential biomarker has been identified in immunotherapy: tumor mutational burden (TMB), an assessment of the number of relevant mutations in a tumor. 

    NTRK

    NTRK

    Development of NTRK Reference Materials for Global Assay Standardization

    Genomic cancer testing is a powerful tool for identifying the individual and often complex genomic alterations underlying carcinogenesis and cancer progression. SeraCare has developed reference material that contains 15 clinically-relevant NTRK fusions in a single reference sample.

    cfDNA

    cfDNA

    Validation of a Novel One-Step Digital PCR Platform with Precision Circulating Cell-Free DNA Standards

    EGFR (epidermal growth factor receptor) mutation testing is an important drug target for the treatment of non-small cell lung carcinoma (NSCLC). Read about the validation of a novel, fully integrated dPCR platform for the detection and absolute quantification of EGFR T790M.

    Multi-Center Evaluation of Circulating Tumor DNA Assays

    ctDNA

    Multi-Center Evaluation of Circulating Tumor DNA Assays

    Measurements of circulating tumor DNA (ctDNA) hold great potential to detect residual disease and monitor therapeutic response and tumor evolution. However, there are many technical challenges including trace levels of circulating cell free DNA, short DNA fragment sizes, low variant allelic fractions, and the need to detect all variant types.

    A Non-Small Cell Lung Cancer Reference Material

    NSCLC

    A Non-Small Cell Lung Cancer Reference Material

    About 10-50% of NSCLCs have one of several activating EGFR driver mutations which have been clinically validated as therapeutic biomarkers for anti-EGFR drugs. Identifying these driver mutations through liquid biopsies is a promising alternative to traditional biopsies; however, the precision of mutation analysis for some of these targets remains a challenge. 

    Consistent Performance of Highly Multiplexed RNA Fusion Reference Materials Across Different NGS Assays in a Multi-Lab Study

    RNA Fusion

    Consistent Performance of Highly Multiplexed RNA Fusion Reference Materials Across Different NGS Assays in a Multi-Lab Study

    Fusion detection is an important part of cancer disease management, and there is an increasing need for highly multiplexed reference materials to cover mutations which may be rare or difficult to obtain.

    Interlaboratory Assessment of Complex Variant Detection

    SRS

    Interlaboratory Assessment of Complex Variant Detection

    In this study, an international group of collaborating laboratories explored the creation of a synthetic reference sample (SRS) in which multiple technically challenging variants are introduced into a known human genomic background. This single SRS with 23 variants was evaluated using 10 NGS workflows.

    Enabling Standardised Testing of Liquid Biopsy Assays Detecting EGFR Mutations Using Bespoke Reference Materials

    EGFR

    Enabling Standardised Testing of Liquid Biopsy Assays Detecting EGFR Mutations Using Bespoke Reference Materials

    Frequently, patients with non-small cell lung cancer (NSCLC) have limited (if any) tissue available to perform EGFR mutation testing. This can be overcome by testing plasma samples for the presence of mutations in circulating tumor DNA (ctDNA).

    ccfDNA

    ccfDNA

    Use of Molecular Identifiers and Targeted NGS to Enable Variant Detection Below 1% Allele Frequencies in Circulating Cell-Free DNA

    Watch the video to see how Swift BioSciences' analysis accurately and reproducibly identified known variants as low as 0.25%.

    cfDNA

    cfDNA

    CleanPlex UMI Lung Cancer Panel for Detecting Low-Frequency Variants Using Targeted Amplicon Sequencing Approach & Molecular Barcodes

    Watch the video and download this free poster to see how the recovered number of UMIs is one of the keys for accurate detection of rare mutations with fewer false positives.

    ctDNA

    ctDNA

    A Comprehensive, Targeted NGS Method that Rapidly and Accurately Detects ctDNA Variants at 0.1% Frequency in Plasma Samples

    See how this targeted NGS method is able to distinguish a low-frequency ctDNA signal from background noise in plasma cell-free DNA using a streamlined PCR-based workflow.

    Analytical Validation of Oncomine Breast cfDNA Assay v2

    cfDNA

    Analytical Validation of Oncomine Breast cfDNA Assay v2

    MolecularMD performed analytical validation studies for the detection of hotspot mutations and copy number variation using commercially available cfDNA controls, full-length and fragmented cell line DNA dilutions, plasma-derived cfDNA samples and FFPE DNA samples.

    FFPE

    FFPE

    Optimization Studies for the Development of Highly Multiplexed Reference Materials in FFPE Format for Solid Tumor Profiling

    Sourcing individual FFPE samples (remnant patient specimens or cell line derived) for each of the somatic mutations of interest can be expensive and time-consuming.

    ctDNA

    ctDNA

    Use of Amplified and Synthetic ctDNA to Assess Variant Calls from Targeted NGS Panels

    The detection of somatic mutations in circulating cell-free DNA(ccfDNA) from plasma samples using next-generation sequencing (NGS) panels is one of the most exciting developments in oncology diagnostics. However...

    ctDNA

    ctDNA

    New Technology to Generate Commutable and Comprehensive ctDNA Reference Materials for NGS

    The need for commutable and comprehensive ctDNA reference materials is evident from the increasing number of liquid biopsy diagnostics and comprehensive panels on the market that are accompanied by reports of discordant results.

    NIPT

    NIPT

    Highly Stable and Commutable NIPT Reference Materials for Validation, Proficiency Testing and Quality Control

    Plasma-based DNA next-generation sequencing (NGS) diagnostics for non-invasive prenatal testing (NIPT) has exploded in popularity in recent years. However...

    HCV RNA

    HCV RNA

    Technology to Produce Non-Infectious Recombinant Virus as Reference Materials for Unculturable or Highly Dangerous Viral Pathogens

    Diagnostic laboratories and test developers need to design, manufacture, and validate assays for pathogenic viruses and this requires stable, reproducibly manufactured positive reference materials.

    NGS

    NGS

    Development and Testing of Reference Materials for NGS based Somatic Variant Detection and Fusion Detection in Myeloid Cancers

    See how the development of these reference materials aid the development, optimization, and verification of NGS-based myeloid disease testing, providing laboratories greater assurance in their ability to correctly detect these genomic events in myeloid patient samples.

    Plasma Mutation Spectrum Matches Known Tumor Mutations in Active Cancer Patients

    Cancer

    Plasma Mutation Spectrum Matches Known Tumor Mutations in Active Cancer Patients

    UNC evaluated a test system that preferentially amplifies fragmented DNA to reduce impact of ex vivo release of cellular DNA, and that capitalizes on “unique molecular identifiers” and variable amplicon lengths to improve assay performance.

    ctDNA

    ctDNA

    Evaluation of Customizable Circulating Tumor DNA (ctDNA) Reference Materials with Multiple Assays

    The utility of circulating cell-free DNA (ccfDNA) has led to the development of an ever-increasing number of ctDNA assays that also make use of fundamentally different analytic methods.

    Application SiMSen-Seq

    ctDNA

    Application of the Highly Sensitive SiMSen-Seq Assay and Seraseq®-Designed Reference Materials to Minimal Residual Disease Detection

    The reliable detection of minimal residual disease (MRD) becomes possible as ctDNA assays become more sensitive. Sensitive assays require matched reference materials.

    A Novel Circulating Tumor DNA Reference Material Compared on Next-Generation Sequencing to Digital PCR Assays

    ctDNA

    A Novel Circulating Tumor DNA Reference Material Compared on Next-Generation Sequencing to Digital PCR Assays

    Watch the video and download this free poster to see how SeraCare has developed a size-selection and DNA processing method to mimic the size profile of native ctDNA.

    Enrichment Panels

    NGS

    Flexible Tools For The Development And Performance Verification Of Customized Target Enrichment Panels

    Implementation of next-generation sequencing for variant identification and discovery presents difficulties both in the selection of genomic loci for inclusion in a panel, as well as the ability

    Multi-Lab Assessment

    ctDNA

    Multi-Laboratory Assessment of a New Reference Material for Quality Assurance of Circulating Tumor DNA Measurements

    The accurate diagnosis and monitoring of cancer, using circulating tumor DNA, is a major challenge, given the low concentration and complexity of the target molecules.

    Donor Derived ccfDNA

    ccfDNA

    Donor-Derived Circulating Cell-Free DNA (ccfDNA) Reference Materials for Concordance Studies

    The limited quantities of ccfDNA in plasma and the limited amount of ccfDNA that can therefore be obtained from a single donor can make it difficult to assess the sensitivities and specificities of

    Highly Multiplexed Reference Materials

    RNA Fusion

    Use of Highly Multiplexed Reference Materials to Facilitate Validation of a Clinical NGS Tumor Fusion RNA Assay

    NGS Tumor Fusion RNA Assay Next-generation sequencing (NGS) assays for detection of tumor RNA fusions must undergo rigorous validation before clinical implementation.

    Custom VariantFlex

    VariantFlex

    Custom VariantFlex Technology Allows Rapid Design and Testing of Reference Materials for Tumor Genotyping Assays

    Development and validation of tumor genotyping assays requires highly characterized reference materials for effective assessment of accuracy, precision,

    Well Characterized Breast

    CNVs

    Development of Well Characterized Breast, Lung, and Brain Cancer Copy Number Variation Reference Materials

    Copy number variation (CNV) can be a key driver of oncogenesis. Pathogenic CNVs are often associated with unfavorable prognosis and drug resistance.

    Scientific Poster video NGS validation

    NGS Validation

    Reliable Interpretation of NGS Data Using Highly-Multiplexed Reference Material

    This video shows how Directed Genomics and New England Biolabs use highly multiplexed reference materials during optimization and validation to fine-tune assay performance.

    ctDNA scientific poster video

    Liquid Biopsy

    An Efficient and Ultrasensitive NGS Solution for Profiling ctDNA

    Asuragen’s Associate Director of Bioinformatics explains how SeraCare’s ctDNA allows confident quantification of trace levels of ctDNA in their NGS-based assay.

    Assessing Sensitivity of NGS RNA Fusion Assays Using a Multiplexed and Well-Characterized Linearity Panel

    RNA Fusion

    Assessing Sensitivity of NGS RNA Fusion Assays Using a Multiplexed and Well-Characterized Linearity Panel

    Many targeted NGS-based panels have been introduced to detect RNA fusions useful for prognosis and therapy selection in cancer.

    ccfDNA Isolated

    ccfDNA

    Circulating Cell Free DNA Isolated and Amplified from the Plasma of Pancreatic Cancer Patients as Reference Material for ctDNA Assays

    The validation and evaluation of circulating tumor DNA (ctDNA) assays poses analytical challenges because the amount of circulating cell-free DNA (ccfDNA) that can be obtained

    Patient Like ctDNA

    ctDNA

    Patient-Like Circulating Tumor DNA Reference Materials for Evaluation of Next-Generation Sequencing Tests

    Clinical oncologists are relying on analysis of circulating tumor DNA (ctDNA) across an increasing number of applications.

    AccuSpan Zika

    Zika

    AccuSpan™ Zika Linearity Panel Spans the Dynamic Range of Assays and Allows Evaluation of Analytical Sensitivity

    In response to the Zika virus outbreak, several PCR-based assays have been developed and approved under the Emergency Use Authorization (EUA).

    Multiplexed NGS Inherited Disorders

    NGS

    Multiplexed Next-Generation Sequencing Reference Materials for Testing of Inherited Disorders

    Next-generation sequencing (NGS) has rapidly advanced the genetic testing for inherited disorders.

    Commutable ctDNA Reference Material

    ctDNA

    A Commutable Circulating Tumor DNA (ctDNA) Reference Material

    Commutability is an important aspect of reference materials and relates to how well the materials can mimic the natural analyte.

    Development RM Inherited Cancer

    NGS

    Development of Highly Multiplexed Reference Materials for Inherited Cancer Testing

    Next Generation sequencing (NGS) has improved the diagonistic yield of genetic testing, but has presented new challenges for test development, validation and quality control management.

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