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Though the test is already commercially available, the firm met with the FDA last year to discuss plans for a randomized controlled trial to support regulatory approval.

How labs — including those that are part of other healthcare systems — offering PGx testing will react to Inova's decision to not engage with the FDA remains to be seen.

The iPod-sized system integrates a microcontroller, a peristaltic pump, heparin injector, and microfluidic chip to capture tumor cells in a patient's bloodstream. 

The genetic disease risk test, which covers 59 genes endorsed by ACMG, is offered through the Helix marketplace and includes genetic counseling services.