The year brought more FDA approvals for molecularly targeted drugs and NGS tests for personalizing cancer treatment, but reimbursement remained a stress point for industry.
The law contains provisions that proponents say will advance precision medicine and speed new tests to market, but critics worry if this will come at a cost to public health.
The Genetic Research Privacy Protection Act would ensure that federally funded researchers can't reveal genetic data that can identify study participants.
NextGxDx estimates more than 60,000 genetic test products would come under FDA oversight, which, if accurate, industry players fear would overburden test developers.
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.
