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.
HalioDx said that Chinese oncologists will gain access to its Immunoscore assay for predicting the risk of recurrence of early-stage colon cancer.
The method, presented at the European Congress of Clinical Microbiology and Infectious Diseases, may provide results in hours rather than a week or more.
A bi-weekly listing of recent local coverage determinations from Medicare Administrative Contractors.