Article preview from "The Gray Sheet" - July 12, 2010
FDA is taking a proactive look at a new type of complex genetic test that challenges the agency's typical model for reviewing and approving diagnostics.
FDA Attempts To Carve Out Regulatory Policy For Cytogenetic Tests
By Jessica Bylander
FDA is taking a proactive look at a new type of complex genetic test that challenges the agency's typical model for reviewing and approving diagnostics.
The agency's device center held a workshop June 30 on array-based cytogenetic tests, which detect DNA copy number changes that may be indicative of congenital anomalies or developmental disabilities, to help forge a regulatory strategy for the tests.
"In many ways, we are a little bit late coming to the table," acknowledged Alberto Gutierrez, director of CDRH's Office of In Vitro Diagnostic Device Evaluation and Safety.
"It's become the way of doing medicine. And yet, it's falling into an unregulated hole," Gutierrez said.
While cytogenetic arrays currently are used in laboratories as research tools and no firms have submitted pre-market applications, "we've had companies express interest," Elizabeth Mansfield, director of the personalized medicine staff at FDA's diagnostics office, explained in an interview with "The Gray Sheet."
Participants at the workshop discussed validation strategies and other requirements for companies seeking clearance or approval for the tests.
FDA is struggling with how to validate the performance of the tests and determine whether results are clinically meaningful.
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