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Updated: Apr 22, 2026
09:34
Targeted Next-generation Sequencing and Bioinformatics Pipeline to Evaluate Genetic Determinants of Constitutional Disease
Published on: April 4, 2018
36.1K
Economic regulation of next-generation sequencing
1Professor of Law, the George Butler Research Professor, and the Director of the Center for Biotechnology & Law at the University of Houston Law Center.
Summary
Next-generation sequencing necessitates new regulations for the genetic testing industry. Addressing data access issues is crucial for consumer safety, potentially through antitrust law or legislative action.
Area of Science:
- Genomic medicine
- Regulatory science
- Health economics
Background:
- Next-generation sequencing (NGS) is transforming genetic testing, raising complex regulatory questions.
- Current regulations focus on privacy and safety but overlook industry structure and economic issues.
- The genetic testing industry is undergoing rapid structural changes due to technological and legal shifts.
Purpose of the Study:
- To analyze the evolving structure of the genetic testing industry.
- To identify the economic regulatory vacuum concerning data access.
- To explore potential legal solutions for ensuring consumer access to comprehensive genomic data.
Main Methods:
- Analysis of the current genetic testing industry structure.
- Review of existing regulatory frameworks (CLIA, FDA).
- Exploration of antitrust law and the essential facilities doctrine.
Main Results:
- Significant barriers to accessing comprehensive genomic data infrastructures exist.
- No sector-specific regulator currently ensures appropriate data access.
- Antitrust law, particularly the essential facilities doctrine, may offer viable solutions in some jurisdictions.
Conclusions:
- The lack of data access regulation poses health and safety risks to consumers.
- Judicial solutions, especially in Europe, show promise for addressing data access issues.
- Legislative action may also be necessary to ensure safe and effective genetic testing.
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