FDA Approves First Next-Generation DNA Sequencing Platforms
This article was originally published in The Gray Sheet
Illumina’s MiSeqDx instrument and MiSeqDx Universal Kit, granted de novo approval, allow clinicians to “develop and validate sequencing of any part of a patient’s genome,” FDA says.
You may also be interested in...
A top reviewer in US FDA's in vitro diagnostics office offers tips to next-generation sequencing test sponsors to avoid common submission shortcomings in this interview with Medtech Insight. According to FDA's Hisani Madison, sponsors frequently fall short in providing a refined intended-use statement.
FDA issued orders officially finalizing regulatory classifications and special controls for next-generation sequencing analyzers; "secondary display" devices for continuous glucose monitor data; and vibratory counter-stimulation devices for restless leg syndrome. And the agency is working towards formalizing 510(k) exemptions for future devices of these types as well.
Two recent next-generation sequencing draft guidances have been positively received so far by industry and clinical research groups. But for FDA's ideas to play out, more databases will need to be populated and more standards developed, agency officials say. There are also more guidances to come on different types of NGS tests. Read our coverage below, and also listen to our podcast interview with FDA's Elizabeth Mansfield.