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出生前診断:侵襲的検査、非侵襲的検査、および子癇前症・早期陣痛向け母体スクリーニング手法の増加

Prenatal Diagnostics: Invasive Testing, Noninvasive Testing, and Rising Maternal Screening Methods for Preeclampsia and Preterm Labor

発行 Insight Pharma Reports 商品コード 291114
出版日 ページ情報 英文 140 Pages
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出生前診断:侵襲的検査、非侵襲的検査、および子癇前症・早期陣痛向け母体スクリーニング手法の増加 Prenatal Diagnostics: Invasive Testing, Noninvasive Testing, and Rising Maternal Screening Methods for Preeclampsia and Preterm Labor
出版日: 2015年04月09日 ページ情報: 英文 140 Pages
概要

当レポートでは、侵襲的処置(染色体分析 vs. 細胞遺伝学)、および非侵襲的スクリーニング手法の増加とそのこと妊婦の健康に及ぼす影響について調査し、マイクロアレイベースの細胞遺伝学の分析と染色体分析との比較、主要企業のプロファイル、および人口統計調査結果などを提供しています。

エグゼクティブサマリー

パート?:出生前アプリケーション

第1章 侵襲的検査

第2章 非侵襲的検査

パートII:非侵襲的出生前アプリケーション

第3章 Sequenom

  • 企業背景
  • 研究分野
  • MaterniT21 PLUS
  • MaterniT21 PLUS の検証
  • 競争上の優位性
  • William Welch氏、Dirk van den Boom氏、Allan Bombard 氏へのインタビュー

第4章 Verinata Health

  • 企業背景
  • The verifi出生前検査
  • 直面する課題
  • 臨床評価・医療費償還
  • 顧客フィードバック
  • Richard Rava 氏へのインタビュー

第5章 Ariosa Diagnostics

  • 企業背景
  • Harmony Prenatal Test (非侵襲的出生前検査)
  • 競争上の優位性
  • 将来の試み
  • Tom Musci 氏へのインタビュー

第6章 Natera

  • 企業背景
  • Panorama
  • プラットフォームの改善
  • 検証
  • 直面する課題
  • 競争上の優位性
  • 将来の試み
  • Solomon Moshkevich 氏へのインタビュー

第7章 Silicon Biosystems

  • 企業背景
  • DEPArray System
  • 直面する課題
  • 競争上の優位性
  • 将来の試み
  • Robert Proulx 氏へのインタビュー

第8章 非侵襲的スクリーニング検査の仕様

パートIII:出生前の合併症

第9章 出生前の合併症

第10章 Metabolomic Diagnostics

  • 企業背景
  • 子癇前症検査
  • 競争上の優位性
  • 将来の試み
  • Charles Garvey 氏へのインタビュー

第11章 NX PharmaGen

  • 企業背景
  • NeXosome のプラットフォーム
  • 競争上の優位性
  • 将来の試み
  • Dr. Alan Ezrin および Brian Brohman 氏へのインタビュー

パートIV:人口統計調査

第12章 調査結果

  • 調査統計
  • 研究分野
  • 直面する課題
  • 出生前診断に用いられるアプリケーション
  • 競合戦略

パートV:企業ディレクトリ - 出生前診断の分野で活動する企業のリスト

Cambridge Healthtech Institute について

図表

目次

New to Insight Pharma Reports is Prenatal Diagnostics: Invasive Testing, Noninvasive Testing, and Rising Maternal Screening Methods for Preeclampsia and Preterm Labor. This report discusses improvements in invasive procedures (karyotyping vs. cytogenetics), and the rise of noninvasive screening methods and their impact on prenatal healthcare. Although covering standard invasive procedure, this report focuses on the noninvasive technologies either on the market or in development.

VIDEO DEMONSTRATION

The first chapter of this report discusses microarray-based cytogenetics and how it compares to karyotyping. Karyotyping is often the standard method used to detect chromosomal aneuploidies, but with microarray-based procedures even more aneuploidies can be detected with the same efficacy. Either method can be used in sync with noninvasive procedures that show positive screening results for aneuploidies, but microarray analysis may be more useful for copy number variations that often go undetected with karyotyping.

Highlighting noninvasive methods, several companies have come out with novel technologies that allow them to analyze fetal DNA without risk of injury to the mother or fetus. Amniocentesis and chorionic villus sampling are common methods used to analyze fetal DNA for aneuploidies but at the risk of miscarriage and infection. With noninvasive procedures, screening can be done for common aneuploidies and further analysis can be done on women with only positive results. This not only decreases the amount of unnecessary invasive testing but also the amount of unnecessary stress levels of many expecting mothers. Companies participating in this section include:

  • Sequenom
  • Verinata Health
  • Ariosa Diagnostics
  • Natera
  • Silicon Biosystems

Other areas discussed in this report include preeclampsia and preterm labor. Preeclampsia is a common condition in women and often isn't detected until later in pregnancy. It can lead to preterm labor, which may be fatal for both the fetus and the mother. So far, a test to screen for the likelihood of preeclampsia does not exist. Detecting the risk of preeclampsia early in pregnancy can allow the expecting mother to take necessary action to avoid preterm labor at all costs, decreasing any complications that may severely affect the fetus including death. Companies highlighted in this section include:

  • Metabolomic Diagnostics
  • NX PharmaGen

In addition to covering several aspects of prenatal diagnostics, this report also includes specifications of particular instruments, exclusive interviews with CEOs, CSOs, and Vice Presidents of the participating companies. Specific areas of focus include company goals, customer feedback, challenges encountered, competitive advantage, platform pricing, and future endeavors. A survey capturing the demographics of the prenatal industry is presented at the end of the report, specifically highlighting organizational background, areas of research, challenges encountered, and applications in development.

Also included is a directory of companies that were and were not interviewed for this report.

Table of Contents

Executive Summary

Part I: Prenatal Applications

CHAPTER 1: Invasive Testing

  • Karyotyping
  • Microarray analysis

CHAPTER 2: Noninvasive Testing

  • Sequence-based cell-free DNA testing
  • Fetal cell isolation

Part II: Noninvasive Prenatal Applications

CHAPTER 3: Sequenom

  • Company background
  • Areas of Research
  • MaterniT21™ PLUS
  • MaterniT21 PLUS validation
  • Competitive advantage
  • Future endeavors
  • Interview with William Welch; Dirk van den Boom; and Allan Bombard
    • Company background
    • Technologies in development
    • SEQureDx platform
    • MaterniT21 platform
    • Validation techniques
    • Areas of improvement
    • Competitive advantage
    • Customer feedback
    • Future endeavors

CHAPTER 4: Verinata Health

  • Company background
  • The verifi® prenatal test
  • Challenges encountered
  • Clinical validation and reimbursement
  • Customer feedback
  • Interview with Richard Rava
    • Company background
    • verifi® prenatal test
    • Challenges encountered
    • Competitive advantage

CHAPTER 5: Ariosa Diagnostics

  • Company background
  • Harmony Prenatal Test
  • Competitive advantage
  • Future endeavors
  • Interview with Tom Musci
    • Company background
    • Harmony Test
    • Competitive advantage
    • Future endeavors

CHAPTER 6: Natera

  • Company background
  • Panorama
  • Platform improvements
  • Validation
  • Challenges encountered
  • Competitive advantage
  • Future endeavors
  • Interview with Solomon Moshkevich
    • Company background
    • Panorama
    • Platform improvements
    • Validation
    • Challenges encountered
    • Customer feedback
    • Competitive advantage
    • Future endeavors

CHAPTER 7: Silicon Biosystems

  • Company background
  • DEPArray System
  • Challenges encountered
  • Competitive advantage
  • Future endeavors
  • Interview with Robert Proulx
    • Company background
    • DEPArray Platform
    • Challenges encountered
    • Customer feedback
    • Future endeavors

CHAPTER 8: Noninvasive Screening Test Specifications

Part III: Prenatal Complications

CHAPTER 9: Prenatal Complications

  • Preeclampsia
  • Preterm labor

CHAPTER 10: Metabolomic Diagnostics

  • Company background
  • Preeclampsia screening test
  • Competitive advantage
  • Future endeavors
  • Interview with Charles Garvey
    • Company background
    • Areas of research
    • Competitive advantage
    • Future endeavors

CHAPTER 11: NX PharmaGen

  • Company background
  • NeXosome platform
  • Competitive advantage
  • Future endeavors
  • Interview questions with Dr. Alan Ezrin and Brian Brohman
    • Company background
    • Preterm labor assays
    • Challenges encountered
    • Competitive advantage
    • Future endeavors

Part IV: Demographic Survey

CHAPTER 12: Survey Results

  • Survey demographics
  • Areas of research
  • Challenges encountered
  • Applications being used for prenatal diagnostics
  • Competitive strategies

Part V: Company Directory: A list of companies working in Prenatal Diagnostics

References

About Cambridge Healthtech Institute

Figures:

  • Figure 12.1: Survey demographics
  • Figure 12.2: Screening vs. testing
  • Figure 12.3: Specific areas of research
  • Figure 12.4: Challenges encountered
  • Figure 12.5: Preferred applications of use
  • Figure 12.6: Competitive strategies

Tables:

  • Table 3.1: MaterniT21 PLUS aneuploidy performance
  • Table 3.2: MaterniT21 PLUS
  • Table 4.1: verifi prenatal test performance for aneuploidies
  • Table 4.2: verifi prenatal test performance for sex chromosomes
  • Table 4.3: verifi prenatal test
  • Table 5.1 Harmony Test
  • Table 6.1: Panorama Test
  • Table 7.1: DEPArray System
  • Table 8.1: Noninvasive screening test specifications
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