PMC | GenomeWeb

PMC

The Genetic Research Privacy Protection Act would ensure that federally funded researchers can't reveal genetic data that can identify study participants.

Since the PMI will take some time and more funds to implement, experts believe legislation is needed to ensure the project has continued support.

NextGxDx estimates more than 60,000 genetic test products would come under FDA oversight, which, if accurate, industry players fear would overburden test developers.

FDA Approved

More than a quarter of new drugs approved by the Food and Drug Administration in 2015 were personalized medicines, the Personalized Medicine Coalition says.

The US Food and Drug Administration has approved four molecularly targeted drugs this month, suggesting that personalized medicine has "turned a corner."

The tool is aimed at facilitating a simple and efficient process that payors can use to asses a CDx's value and if further technology assessments are warranted.

Around 70 percent of cancer compounds and 40 percent of compounds for all indications are being developed with biomarker data.

The group hopes its proposed regulatory framework might strike a compromise between different industry stakeholders.

The discussion document contains many proposals for modernizing the way drugs and medical devices are advanced, but legislators are conspicuously silent on diagnostic regulations, specifically LDTs. 

At the second day of an LDT workshop, industry players told FDA to provide more guidance and details on regulatory areas that the initial draft guidance doesn't touch on.

Pages

In Nature this week: epigenetic contributors to type 1 diabetes, assembly algorithm to detect structural variations, and more.

The Financial Times looks into how sequencing is moving into the clinic.

Mitochondrial replacement therapy may soon be occurring in the UK, according to the Guardian.

The US House of Representatives has passed the latest version of the 21st Century Cures Act.