The genetic disease risk test, which covers 59 genes endorsed by ACMG, is offered through the Helix marketplace and includes genetic counseling services.
Respiratory tract infections, particularly pneumonia, were the most common HAIs, accounting for a quarter of all HAIs in hospitals and a third in long-term care facilities.
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.
Industry executives said that clinical needs associated with antimicrobial resistance and sepsis are generating more interest in AST technologies.
BrightEdge was founded by the American Cancer Society to invest in for-profit companies developing novel cancer therapeutics and diagnostics.
A bi-weekly listing of recent local coverage determinations from Medicare Administrative Contractors.