Absent FDA Guidance on Sequencing-Based Tests, Personalized Rx Experts Weigh in with Ideas | GenomeWeb

By Turna Ray

It's a given that technology moves faster than regulation, but when it comes to the US Food and Drug Administration's framework for laboratory-developed tests, the pace of progress has been particularly slow.

Four months after the FDA announced its intent to regulate LDTs, the agency has yet to put any meat on the bones of its plan to base forthcoming regulations on the intended use and the risk of a given test, and FDA officials have reiterated that they are keeping all ideas on the table.

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The comment period on the Department of Health and Human Services' proposal to alter the Common Rule has been extended.

In Nucleic Acids Research this week: personal genome approach to RNA-seq read alignment, hematopoietic Systems Biology Repository, and more.

A man is using DNA evidence to argue that he is the rightful heir to the baronetcy of Stichill, the Guardian reports.

As part of an effort to get a diverse group of people to donate their DNA for research, some blood donors in the San Diego area will get their genomes sequenced, according to KPBS.