Prenatal Diagnostic Testing - Overview

Prenatal Diagnostic Testing - Overview

Category

Pharmaceuticals

Published Date

1st Apr 2015

Pages

140

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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
Prenatal Diagnostic Testing - 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
Prenatal Diagnostic Testing - Figures and Tables
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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