Steve Halasey, CLP.

Steve Halasey, CLP.

In the agency’s own words, FDA “plays an integral role in President Obama’s Precision Medicine Initiative, which foresees the day when an individual’s medical care will be tailored in part based on their unique characteristics and genetic make-up.” Along the way, the agency will also face challenges about how to regulate the many forms of personalized healthcare products expected to emerge from the federal initiative—including the vast amount of genomic data that may be generated by diagnostics and other tools making use of high-throughput, next-generation sequencing (NGS).

Recognizing the importance of such regulation, in 2014 FDA began investigating the concept of a research and development portal that would allow members of the genomics community to test, pilot, and validate existing and new bioinformatics approaches for processing genomic data. With help from the agency’s Center for Devices and Radiological Health, these early investigations led to the July 2015 launch of a new initiative, precisionFDA, which took its first public steps in the middle of December with the rollout of a beta Web site at

The precisionFDA initiative 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. Although the precisionFDA initiative does not serve a regulatory role, the agency expects that the project will “generate knowledge to inform future regulatory pathways and decision-making.”

The Personalized Medicine Coalition (PMC), Washington, DC, was quick to commend FDA for its efforts to engage stakeholders as it decides whether and how to use curated databases for regulatory oversight of NGS technologies. “PrecisionFDA is an encouraging effort to engage the personalized medicine community in FDA’s decision-making processes,” says Daryl Pritchard, PhD, PMC vice president for science policy. “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.”

Clinical laboratories that are engaged in creating laboratory-developed tests already have significant reasons to be mindful of FDA initiatives that could affect the future shape of the marketplace—and their future business. With the long-term potential of NGS technologies for use in clinical diagnostic applications, paying attention to the precisionFDA initiative is one more task that labs need to keep on their to-do list.

Steve Halasey
Chief Editor, CLP
[email protected]
(626) 219-0199