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Prenatal Diagnostic Testing - Overview

Prenatal Diagnostic Testing - Overview
$2,495.00
$2,495.00
  • Jan 04, 2015
  • 140 pages
  • Insight Pharma Reports
Abstract
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.

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

Report Highlights:
Company goals, customer feedback, challenges encountered, competitive advantage, platform pricing, and future endeavors
An exclusive Insight Pharma Reports survey specifically highlighting organizational background, areas of research, challenges encountered, and applications in development
Clinical trial and pipeline data on over 120 products
Over 130 Company Profiles
Exclusive interviews with:
Vardit Ravitsky, PhD Associate Professor, Bioethics Programs, School of Public Health, University of Montreal
Tom Musci, Chief Medical Officer of Ariosa Diagnostics
Richard Rava, Vice President, Research and Development of Verinata
Solomon Moshkevich, Vice-President, Marketing and Business Development of Natera
Robert Proulx, President & GM U.S. Operations of Silicon Biosystems
Charles Garvey, Chief Executive Officer of Metabolomic Diagnostics
Dr. Alan Ezrin and Brian Brohman, Co-Founder, Chief Executive Officer of NX PharmaGen; Chief Business Officer of NX PharmaGen
William Welch; Dirk van den Boom; and Allan Bombard, President and Chief Operating Officer of Sequenom; Executive Vice President, Research & Development and Chief Technology Officer of Sequenom; Chief Medical Officer of Sequenom
Table of Contents
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
List of 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
List of 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 Sy
Companies Covered