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FDA

The test MRSA and MSSA directly from blood culture samples in about one hour, compared to between 48 and 72 hours with other methods, the company said. 

The draft bill, based on a proposal developed by a coalition of Dx manufacturers and labs, would split oversight responsibilities across the FDA, CMS, and states. 

Excitement and Risk

CRISPR may make gene-editing easier, but it may also make regulation harder, according to New Scientist.

The firm said the assay provides flexible automation and accurately identifies all six HCV genotypes as well as subtypes 1a and 1b.

The list includes "high throughput DNA sequence analyzer," "DNA genetic analyzer," and "mass spectrometer for clinical multiplex test systems." 

President Donald Trump taps Scott Gottlieb, an American Enterprise Institute fellow, to run the Food and Drug Administration.

Move It Along

In a speech to Congress, President Donald Trump called the drug approval process at FDA "slow and burdensome."

Stakeholder input on FDA's draft Rx/Dx codevelopment guidance signals that precision medicine is actually developed differently than the agency wants it to be.

The multi-center precision medicine trial has matched approximately 700 patients to 24 treatment arms so far, but some arms appear to be falling short of their recruitment goal.

The RNA-based blood test takes less than five hours to detect the presence or absence of infection in patients who may have sepsis.

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Pacific Biosciences is hosting a competition in which researchers are vying to win free sequencing for an organism with the most interesting genome.

An opinion piece appearing in Newsday likens familial DNA searches to stop-and-frisk policies.

The San people of Africa have drawn up a code of conduct for researchers, according to the Conversation.

In Nature this week: genotypes linked to hip osteoarthritis, and more.