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Global Clinical Next-Generation Sequencing Market

  • ID: 3517288
  • Report
  • Region: Global
  • 71 Pages
  • Frost & Sullivan
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Learn the Emerging Clinical Applications and Best Practices to the Road to Reimbursement
This market insight covers the challenges associated with the adoption of next-generation sequencing (NGS)-based testing for routine diagnostic use. Emerging applications for gene panel and whole exome sequencing are discussed. Best practices and guidance have been provided to attain coverage on newly launched tests through case study analysis. Tables have been provided for select companies providing NGS-based testing for clinical use, pricing of panels, and CAP survey analysis. Profiles of direct-to-consumer testing genetic testing companies are provided in the report.

Where?

The market is inclined towards the use of NGS testing within prenatal testing, oncology, inherited diseases, and transplant diagnostics. China remains an attractive market with well-established guidelines to regulate the use of gene tests. Unlike other countries, China has offered support to hospital labs to deploy NGS-based testing.

Why?

The cost of the technology and intense labor requirements prohibit adoption of the technology in clinics. Several tests offered in the United States are primarily in the LDT landscape and do not confer the Food and Drug Administration (FDA) route and will be subjected to scrutiny under the new LDT regulation.

How?

Regulatory strategy, study design, and publication strategy lead to a positive coverage decision. These strategies need to be considered at early stages. Successful companies choose the technical platform that suits business, clinical, and test performance needs.
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1. Executive Summary

2. Market Overview

3. Market Outlook

4. Best Practices on Reimbursement Coverage

5. Barriers to Adoption

6. Appendix - Testing Trends by Method
  • List Price of Selected NGS-based Tests - United States
  • Profiles of Companies Offering NGS Clinical Tests - United States
  • Profiles of Companies Offering Direct-to-consumer Testing - Global
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