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Coalition Commends FDA’s Launch of Community Platform for Evaluating Approaches to Next-Generation Sequencing Analysis


Effort becomes latest in flurry of agency activities supporting personalized medicine

WASHINGTON (December 15, 2015)

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The Personalized Medicine Coalition (PMC) today commends what Daryl Pritchard, Ph.D., vice president, science policy, called an “encouraging effort” by FDA to engage stakeholders as it decides whether and how to use curated databases for regulatory oversight of next-generation sequencing (NGS) technologies.

The initiative, called “precisionFDA,” provides a publicly accessible online portal that enables community members to conduct genome analyses for comparison against reference material, then publish the results for review. The agency began its public roll-out of the portal today by launching an open beta version of the tool. According to the agency’s website, the project is expected to “generate knowledge to inform future regulatory pathways and decision-making.” 

“PrecisionFDA is an encouraging effort to engage the personalized medicine community in its decision-making processes,” Pritchard said. “We hope stakeholders will use it and participate in its continued development. We look forward to working with FDA as the agency continues to consider the implications of various approaches to NGS oversight.”  

One of the first deliverables to arise out of the President’s Precision Medicine Initiative, precisionFDA is the latest in a flurry of FDA activities that support personalized medicine. After expediting approval for 90 percent of targeted therapies approved in 2014, the agency set a record in July of this year by approving four personalized medicine indications in one month. 

“Keeping up with scientific advancements in personalized medicine is difficult, but FDA is addressing the challenge,” Pritchard said.   

FDA announced the precisionFDA concept during a public workshop on NGS oversight in November, as a strategy for helping to determine whether a database of reference material could be useful for evaluating the validity of conclusions generated by NGS assays.

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Contact:
Chris Wells
cwells@personalizedmedicinecoalition.org
Phone: 202-589-1755

About the Personalized Medicine Coalition:
The Personalized Medicine Coalition, representing innovators, scientists, patients, providers and payers, promotes the understanding and adoption of personalized medicine concepts, services and products to benefit patients and the health system. For more information about PMC, please visit www.personalizedmedicinecoalition.org.

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