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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Harold Varmus, a former NIH director, says that proposed reductions to the agency's budget are worrisome.

The Genome 10K project is to sequence about 10,000 vertebrate genomes, including ones of endangered species, Digital Trends reports.

The new Coalition to Save NIH Funding aims to educate lawmakers and the public on the significance of biomedical research.

In PLOS this week: analysis of viral sequences from human blood samples, gut microbiomes of heart failure patients, and more.

Mar
30
Sponsored by
SeraCare

Our roundtable of industry experts will provide an overview of the current regulatory landscape for clinical genomics tests.

Apr
13
Sponsored by
SeraCare

In this webinar, Gregory J. Tsongalis of Dartmouth Hitchcock Medical Center will discuss how his lab developed and validated a cancer hotspot assay. 

Apr
27
Sponsored by
SeraCare

This webinar is the third in a four-part series highlighting real-world examples of how some lab directors are bringing validated next-generation sequencing-based tests to the clinic.

May
09
Sponsored by
SeraCare

This webinar is the last in a four-part series highlighting real-world examples of how some lab directors are bringing validated next-generation sequencing-based tests to the clinic.