Oversight of US genetic testing laboratories

Article Abstract:

The relationship between improved quality of genetic testing and laboratory quality and the attitudes of laboratory directors toward current genetic testing regulation, the value of a genetic testing specialty and the value of PT in ensuring quality testing are examined to explore whether the creation of a genetic testing with specific proficiency testing (PT) standards could improve the quality of genetic testing. The data from the survey clearly demonstrates that laboratory directors support moves to create formal registration under genetic testing specially for centers that carry out such analyses.

Author: Scott, Joan, Hudson, Kathy L., Murphy, Juli A., Kaufman, David J., Javitt, Gail H., Katsanis, Sara H.
Product quality, Quality management, Genetic screening, Genetic testing, Biotechnology laboratories

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Errors in patent application sequence listings

Article Abstract:

The reality of preparing a patent application involves research and legal staff in multiple rounds of writing, editing and review. The most frequent errors identified at the US Patent and Trademark Office include files not being submitted as plain text, incorrect line lengths and line wrapping, missing tags and invalid sequence features, especially those that describe ambiguities in the reported sequence.

Author: Jones, Robert
Evaluation, Patent literature

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An individual approach

Article Abstract:

The US Food and Drug Administration has released guidelines in March 2005 that encourage, but do not require, companies to provide pharmacogenomic data in new applications for drug approval. This information would predict how a patient might respond to a drug based on their genetic profile, both the gene variants they have inherited and the expression pattern of those genes.

Author: Lewis, Ricki
General services, Pharmaceutical preparations, Pharmaceutical industry, Company systems management, Information management, United States. Food and Drug Administration, Pharmacogenetics, Pharmacogenomics

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Subjects list: Standards, United States
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