Vendors may begin marketing a groundbreaking nucleic acid test that detects 12 different bacteria known to cause bloodstream infections up to four days sooner than traditional methods.
FDA approved marketing for the test, citing a study that detected gram-positive bacteria in 1,642 blood samples using conventional laboratory tests and the new Verigene BP Culture Nucleic Acid Test (BC-GP). The BC-GP results were consistent with traditional methods 93% of the time.
The BC-GP method demonstrates further promise in identifying three resistance associated genes, CQ HealthBeat notes.
Alberto Gutierrez, a director at the FDA's Center for Devices and Radiological Health, calls the new test an "important tool that will help physicians treat patients quickly with the correct antibiotics."
Approval for the test comes at a time when the White House has made reducing bloodstream infections in hospitals a top priority. For example, the HHS's Hospital Compare website includes bloodstream infection rates as a quality measure (CQ Healthbeat, 6/27 [subscription required]).
Next in the Daily Briefing
R.I. hospital deal signals changing attitudes toward for-profit chains