454 Life Sciences

Anthony Strattner, From Sanger to ‘Sequenator’, Bio-IT World, Oct. 10, 2003.

In August, 454 Life Sciences announced they had sequenced the entire adenovirus genome in one day.  This article reviews their sequencing technology, the PicoTiterPlate™ system.

Robertson looks at ethical/legal issues of $1k genome

John A. Robertson, The $1000 Genome: Ethical and Legal Issues in Whole Genome Sequencing of Individuals, The American Journal of Bioethics: Volume 3 Number 3. (Article is free: HTML or PDF)

From the abstract:

Using the idea of $1000 genome as a focus, this article reviews the main technical, ethical, and legal issues that must be resolved to make mass genotyping of individuals cost-effective and ethically acceptable. It presents the case for individual ownership of a person’s genome and its information, and shows the implications of that position for rights to informed consent and privacy over sequencing, testing, and disclosing genomic information about identifiable individuals. Legal recognition of a person’s right to control his or her genome and the information that it contains is essential for further progress in applying genomic discoveries to human lives.

The portable genome

Walter Gilbert, of the Hubbard Center for Genome Studies, carries around a copy of the human genome on his Apple iPod.  See articles here and here.

Genomics and Public Health Guide

The Association of State and Territorial Health Officials (ASTHO), has published Genomics: A Guide for Public Health.  According to their monthly newsletter, Genomics Impact, the guide:

provides public health professionals with an overview of genomics and its impact on public health. The guide examines the importance of integrating genomics into public health and provides snapshots of state and local health agencies’ efforts to incorporate genomics into their programs. The CD-ROM contains resources, such as web links, documents, and modifiable presentations that can be used to assist state and local health agencies with their efforts to integrate genomics into public health activities.

For more information see the guide’s companion website.

Genetics Legislation Resources at the NCSL

As part of their Genetics Technology Project, the National Conference of State Legislatures (NCSL) maintains several resources concerning genetics legislation.

An updated list of reports filed by state legislative bodies.

Summaries of recent legislative activity, including the bill name,
state of origin, link to the bill, a summary, and its status. This
activity is divided into the following categories: genetics and privacy, genetics and employment, and genetics and health insurance.

The NCSL also provides tables of information summarizing current laws by state, according to the same categories: privacy, employment, and health insurance

 

Read more

Profile: Perlegen Sciences

David Stipp, Speed Reading your Genes, Fortune, September 1, 2003. (pdf) or (HTML)

Genome Sequencing Technology Roundup

Aileen Constans, Beyond Sanger: Toward the $1000 Genome, The Scientist, June 30, 2003. (article free, registration required)

Constans reviews available and experimental genome sequencing technologies.   

Here is a quick run through of the companies/technologies discussed:

Solexa (Cambridge, UK)
TotalGenotyping™ platform

VisiGen Biotechnologies (Houston, TX)
VisiGen™ sequencing system

454 Life Sciences (Branford, Conn.-based CuraGen subsidiary)
PicoTiterPlate™ system

Pyrosequencing AB
sequence-by-synthesis method

Lynx Therapeutics
Massively parallel signature sequencing method (MPSS)

Perlegen Sciences (Mountain View, Calif.)
sequencing using gene chips

OpGen (Madison, Wis.)
Optical mapping

US Genomics (Woburn, Mass.)
GeneEngine™ technology

Affymatrix
gene chips

George Church, professor of genetics, Harvard Medical School and colleagues
Polymerase colony, or polony method

Harvard Nanopore Group and colleagues
nanopore sequencing

Watt W. Webb, of Cornell and colleagues
zero-mode waveguides

Genomic Data and the FDA

Edward R. Winstead, Genomes and Medicine–Part One, Genome News Network, September 19, 2003.

A brief analysis of how the FDA is dealing with the use of new forms of data, such as microarray data, in regulatory submissions. "The newness is a problem and a challenge. There are no universal standards for analyzing and reporting microarray or other genomic data." 

UPDATE: The FDA recently issued guidance for the submission of pharmacogenomic data.  See the press release here
One notable graf from the press release:

This is FDA’s first step towards integration of this new field into the process of demonstrating that new drugs are safe and effective, and thus the regulatory guidance is intended to facilitate this integration. This guidance is intended to ensure that evolving regulatory policies and study designs are based on the best science; provide public confidence in this new field where scientifically appropriate; facilitate the use of such tests during drug development; and clarify for industry what types of pharmacogenomic data to submit to FDA.

"Using genomic testing to guide drug therapy will constitute a significant shift from the current practice of population-based treatment towards "fine-tuning" individual therapy," said Janet Woodcock, FDA’s Director of the Center for Drug Evaluation and Research.

The Genomic Technology Prize

The J. Craig Venter Science Foundation announced the creation of a one-time $500K Genomic Technology Prize "aimed at stimulating the scientific and technology research community to significantly advance automated DNA sequencing so that a human genome can be sequenced for $1,000 or less as soon as possible."  See the press release.

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