Experts Criticize FDA's Plan To Regulate Genomic Tests
This article was originally published in The Gray Sheet
Legal, ethics and genomic scholars took to the New England Journal of Medicine to criticize FDA's plan to regulate laboratory-developed tests.
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Two promised draft guidances on FDA’s framework for regulating laboratory developed tests and notification and medical device reporting requirements for LDTs have been posted. The agency wants swift notification from labs for most available LDTs once a framework is finalized.
The agency will need to restrain evidence expectations for proving clinical validity in its planned framework for regulating laboratory-developed tests in order to make the framework more feasible, speakers at a Sept. 18 Avalere conference said.
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.