SAMPLE PREP 2015 - 試料調製学会2015 -
2015年6月25 - 26日
米国、メリーランド州、ベセスダ

新規のオミクスアッセイの台頭に追随し、あるいはそれに先立って、分析前/検出前処理の最適化を詳細に検証する必要があります。革新的試料調製と標的濃縮技術は、異種試料または低濃度の検体を含む試料に対して実施する検査の感受性と特異性を大きく向上させる能力をもっています。適切かつ新たな試料調製は、繰返し性と堅牢性を保証するアッセイ開発とバリデーションの極めて重要な部分です。当学会は、臨床、生物学的検出およびバイオサーベイランス分野における最新オミクスアッセイのための試料調製に関する主な課題と最新動向について話し合うためのイベントです。


1日目 | 2日目

6月25日(木)

7:15 参加登録とモーニングコーヒー


ゲノム検査および病原体検出の分析前処理におけるベストプラクティス

8:10 議長による開会の挨拶

8:15 生物検体の生物学的品質評価

Scott-JewellScott D. Jewell, Ph.D., Professor and Director, Program for Technologies and Cores Van Andel Research Institute

Biospecimen quality is affected by preanalytical variable and the analytes from the biospecimen are the targets of that quality assessment. Purity, size, integrity and a functional assessment of nucleic acids are used to measure genomic biospecimen quality. However, a more complex measurement of quality is the assessment of the biology of the biospecimen. We investigate these questions using animal models to provide further improvements in best practices.

8:45 ジョイントプレゼンテーション:革新的かつ非常に統合された分子システムのコアとなる特徴としての試料調製

Randy-RasmussenRandy Rasmussen, Ph.D., President and COO, BioFire Diagnostics

Stephanie Thatcher, Ph.D., Director, Systems Integration, BioFire Diagnostics

Development of molecular detection systems focuses on nucleic acid amplification and detection. This half of the problem gets the grants, the patents and the research time. Unfortunately these systems are often brought to their knees by snot, blood, poop and sputum. The hardest part of highly integrated systems is the sample prep and yet it is the part that is hardest to get people to work on. We will describe the process of learning this lesson with the FilmArray system, how we approach sample prep, and what important factors you should consider during development.

9:30 直接全血検体における細菌感染およびカンジダ感染の高感度分子検出

Lawrence-BlynLawrence B. Blyn, Ph.D., Director, Science and Technology, Ibis Biosciences, Abbott

We describe a sample preparation and detection system that provides for the rapid detection and identification of bacterial and Candidal nucleic acid directly in whole blood specimens from patients with suspected bloodstream infections. A lysis method and DNA purification system were designed for processing 5 ml of whole blood. PCR amplification formulations were optimized for high levels of human DNA. The system provides for rapid and sensitive molecular detection of diverse agents of these clinically important infections in approximately 6h.

10:00 展示会場での休憩とポスターの見学

10:45 適合するホルマリン固定組織および凍結組織検体から得られた結果を比較するための世代シークエンシングアッセイの使用

Patrick-HurbanPatrick Hurban, Ph.D., Vice President, Research and Development, Expression Analysis, The Quintiles Company

Formalin-fixed tissues present many sample preparation, extraction and method development challenges. It can also be challenging to understand whether certain findings stem from intrinsic genetic properties of the sample, or alternatively, are a product of how the sample was handled. Despite advancements in preservation methods, vast collections of FFPE material await analysis. Results will be presented comparing matched formalin-fixed and frozen tumor samples analyzed using a sensitive next-generation sequencing assay.

11:15 標的RNAシークエンシングによる融合検出のためのベストプラクティス:分析前検討事項、アッセイバリデーションなど

Robert-DaberRobert D. Daber, Ph.D., Director, Research and Development and Sequencing Operations, Bio-Reference Laboratories

This presentation will discuss challenges and benefits of NGS based targeted RNA sequencing in the detection of gene fusion events, including, nucleic acid isolation, sample preparation and downstream data processing. There are a number of specific challenges related to RNA sequencing, standardized quality control metrics both before and after library prep are clearly needed.

11:45 スポンサー提供のプレゼンテーション

12:15 ランチプレゼンテーションまたは各自での昼食

1:00 展示会場での休憩とポスターの見学

1:40 議長の挨拶

1:45 癌に関する臨床研究に使用するための多重検体NGSアッセイの準備

Mickey-WilliamsP. Mickey Williams, Ph.D., Director, Molecular Characterization & Clinical Assay Development Laboratory (MoCha), Frederick National Laboratory for Cancer Research

NGS offers a powerful tool for assessment of molecular defects found in cancer. The utilization of NGS is becoming common practice in clinical laboratories. This complex technology requires a new level of analytical performance testing and validation. This discussion will focus on approaches used for analytical validation of the NGS clinical assay used for treatment selection in the NCI-MPACT Study.

2:15 少数臨床試料の多重標的シークエンシング

Curt-ScharfeCurt Scharfe, M.D., Ph.D., Senior Scientist, Stanford Genome Technology Center, Stanford University

Clinical molecular testing increasingly depends on the development and deployment of novel sample preparation technologies. In collaboration with physicians and clinical laboratories we are developing genomic and sequencing assays for the screening and diagnosis of cystic fibrosis, clinical viral infections, newborn and neurodevelopmental conditions and inherited cardiomyopathies. These projects have involved invention of a novel multiplex capture technology, and several innovative improvements in DNA sample preparation. Both approaches have increased speed and accuracy, while lowering costs.

2:45 展示会場での休憩とポスターの見学

3:15 DeepChek、OncoChekプラットフォームを通じたウイルス学および腫瘍学における試料調製とアッセイバリデーションの最適化

Chalom-SayadaChalom Sayada, M.D., Ph.D., Co-founder & CEO, Advanced Biological Laboratories SA

Clinical environments wishing to provide genotyping services in the field of Virology or Human Genetics using Next Generation Sequencing (NGS) need robust, standardized, registered and well-validated software systems. These should be tailored to the optimized management of genomic data resulting in personalized healthcare. Dedicated downstream analysis systems help to perform an accurate, quick and simple analysis of NGS data. This begins with sample preparation and the generation of reads by any type of sequencing platform and ends with simple and easily-understandable reporting ideally suited to clinical interpretation and the connection to the local LIMS. Coupling advanced IT solutions to a well-established sequencing workflow usually helps labs with the validation of new sample prep and innovative assays, enhancing patient management.

3:45 スポンサー提供のプレゼンテーション


4:15 パネル討論会:核酸抽出法とアッセイ目標とのマッチング

Moderator:
Patrick-HurbanPatrick Hurban, Ph.D., Vice President, Research and Development, Expression Analysis, The Quintiles Company





Panelists: Speakers of the Day


4:45 ワークショップへの参加登録

5:30-8:30 ディナーワークショップ (別途登録が必要です。)



1日目 | 2日目

6月26日(金)

8:00 モーニングコーヒー


多重アッセイ:試料調製とバリデーション

8:25 議長の挨拶

8:30 目的に適した生物検体の採取と使用のガイドとなるNational Cancer Instituteのリソース

Helen-MooreHelen Moore, Ph.D., Branch Chief, Biorepositories & Biospecimen Research Branch, Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute

The National Cancer Institute has led the way in developing Best Practices for Biospecimen Resources, sponsoring new research in Biospecimen Science, and building groundbreaking research biospecimen collections including postmortem biospecimens for the NIH GTEx program. New projects to build evidence-based best practices for frozen and FFPE tissues will be described.

9:00 NGSの成功に向けたFFPE試料の評価

Helen-FernandesHelen Fernandes, Ph.D., Associate Professor, Pathology and Laboratory Medicine, Weill Cornell Medical College

This presentation will discuss several important issues, such as: RNA detection in cancer tissues stored in FFPE samples, profiling microRNA expression, FFPE DNA quality control and its correlation with NGS data, and understanding pre-analytic effects on RNA gene expression.

9:30 スポンサー提供のプレゼンテーション

10:00 休憩


様々な適応のための分析前検討事項

10:15 血液検体から直接採取した生菌の即時試料調製

Alexis-Sauer-BudgeAlexis Sauer-Budge, Ph.D., Senior Research Scientist, Fraunhofer Center for Manufacturing Innovation; Adjunct Research Assistant Professor, Biomedical Engineering, Boston University

Traditionally, bacterial pathogens in the blodd have been identified using culture-based methods that can take several days to obtain results. This can lead to physicians making treatment decisions based on an incomplete diagnosis contributing to patient morbidity. To decrease diagnosis time, we are developing a novel sample preparation device for isolating and concentrating dilute bacteria from blood. This presentation will describe the sample preparation device for methodology to isolate viable bacteria from blood which is clean enough for direct PCR or other downstream detection technologies.

10:45 細菌隔離とポータブル検出:分析前検討事項と技術

Sam-NugenSam R. Nugen, Ph.D., Assistant Professor, Department of Food Science, University of Massachusetts, Amherst

The lack of a practical method for bacterial separation remains a hindrance for the low-cost and successful development of rapid detection methods from complex samples. We have developed T7 bacteriophage magnetic probes, where T7 bacteriophage is bound to magnetic particles. The capture efficiencies of bacteriophages on microbeads and nanoparticles for the separation of E. coli K12 were determined. The results indicated that bacteriophage magnetic particles achieved a capture efficiency of 93.7 ツア 1.1% in 15 minutes.

11:15 ポンペ病の原因となる変異を検出するためのGAA次世代シークエンシングのためのマイクロ流体PCR増幅

Patricia Mueller, Ph.D., Chief, Molecular Risk Assessment Laboratory, Newborn Screening and Molecular Biology Branch, Division of Laboratory Sciences, Centers for Disease Control and Prevention (CDC)

We designed a next-generation sequencing assay using primer pairs for PCR amplification and library preparation of up to 48 samples in one Fluidigm Access Array for next-generation sequencing using the MiSeq. This assay can be scaled up using additional Access Arrays in one MiSeq run. The PCR amplification of GAA is challenging due to difficult regions in the gene. All transcribed exon sequences as well as exon/intron borders including those intron sequences containing mutations as identified in the Human Genome Mutation Database (HGMD) were targeted for amplification. Primers were designed not to overlap known HGMD mutations, and variants found in dbSNP were avoided when possible. The data was filtered at a quality score of 竕・ 30 and trimmed. We characterized reference materials including those with missense, nonsense, and splicing mutations; and small insertions and deletions. Large deletions that included exon 18 were independently characterized.

11:45 分析前変数 − バイオマーカーバリデーションにおいて最も脆弱で過小評価されているフェーズ

Apurva K. Srivastava, Ph.D., Principal Scientist, Frederick National Laboratory for Cancer Research Leidos Biomedical Research, Inc.

Contrary to prevalent belief, pre-analytic factors contribute to the most errors documented in clinical laboratories as compared to analytical factors where most efforts are devoted during assay validation. Dr. Srivastava will discuss the general pre-analytical variables for protein assays and how they affect accuracy in clinical laboratory tests. The focus of his presentation will be on identifying the phases of pre-analytical factors with reference to pharmacodynamic/proof-of-mechanism (POM) phospho-protein biomarkers in clinical trials. As a take home message, participants will learn that pre-analytic variables are an underappreciated area in biomarker validation process and improvements in this process will significantly impact accuracy of test results and enable laboratories to focus their quality assurance efforts.

12:15 学会終了


1日目 | 2日目


* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。

 

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