FDA Issues Draft Guidance for DNA Sequencing

President Obama outlined the Precision Medicine Initiative in his 2015 State of the Union address, with a goal toward improving healthcare and reducing costs by harnessing advances in the life sciences and computing. As part of this effort, the FDA has been tasked with developing regulatory processes that promote innovation and ensure accuracy in genomic testing.

Sequencing genomes from a million people to develop a reference database—a key pillar of the FDA initiative—requires high-quality data. (DNA sequencing combines the chemical analysis of DNA fragments using software to assemble the sequences from chemical analyzers into chromosomes and ultimately an individual’s unique genome.)

Recent results from the PrecisionFDA Consistency and Truth Challenges, basically an assessment of methods, show that different DNA sequencing protocols do not provide identical results.1 Potential ambiguity in results might have consequences for efficacy and patient safety. Hence the need for FDA guidance documents to set standards for DNA sequencing: Anticipating advances in sequencing technology, the FDA issued two draft documents for public consideration and reply:

Life scientists involved in DNA sequencing for diagnostics are invited to read both documents, especially the parts relating to laboratory practice and assay design. The FDA is soliciting comments from interested stakeholders within 90 days of July 6, 2016.

References

  1. https://precision.fda.gov/comparisons/1397
  2. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM509838.pdf
  3. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM509837.pdf

Robert L. Stevenson, Ph.D., is Editor Emeritus, American Laboratory/Labcompare; e-mail: [email protected].

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