Regulation of Next Generation Sequencing

Author:

Javitt Gail H.,Carner Katherine Strong

Abstract

Since the first draft of the human genome was published in 2001, DNA sequencing technology has advanced at a remarkable pace. Launched in 1990, the Human Genome Project sought to sequence all three billion base pairs of the haploid human genome, an endeavor that took more than a decade and cost nearly three billion dollars. The subsequent development of so-called “next generation” sequencing (NGS) methods has raised the possibility that real-time, affordable genome sequencing will soon be widely available. Currently, NGS methods can be used to sequence up to 60 billion base pairs per day. Whole-genome sequencing costs an estimated $5,000-10,000, with that number predicted to fall to $1000 in the near future.In the past few years, the availability of high-throughput NGS methods has led to a proliferation of potential and actual clinical applications for NGS. NGS therefore has the potential to usher in the long-awaited era of personalized medicine.

Publisher

Cambridge University Press (CUP)

Subject

Health Policy,General Medicine,Issues, ethics and legal aspects

Reference133 articles.

1. 38. Id. § 263a(a).

2. 108. See Federal Register 76 (May 19, 2011): 28990; Transcript, CDRH Public Meeting on Ultra High Throughput Sequencing for Clinical Diagnostic Applications – Approaches to Assess Analytical Validity (June 23, 2011), available at (last visited July 8, 2014).

3. 78. Federal Register 62 (November 21, 1997): 62,243, 62,249; see Citizen Petition, FDA Docket 1992P-0405, submitted by Hyxnan, Phelps & McNamara, P.C. (Oct. 22, 1992); See Washington Legal Foundation, “Re: Citizen Petition, available at (last visited April 29, 2014).

4. 52. See generally 21 U.S.C. et seq.

5. 57. Id. § 360c(a)(1)(C).

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