NEW YORK (360Dx) – BioMérieux said today that the US Food and Drug Administration has provided clearance for the expanded use of the firm's Vidas Brahms PCT Assay, an automated test that measures levels of procalcitonin, to aid clinical decisions about the optimal use of antibiotics in patients with lower respiratory tract infections or sepsis.
BioMérieux noted that with this clearance, the assay becomes "the first and only FDA-cleared procalcitonin test available in the US market to assist physicians in antibiotic management for patients with suspected or confirmed lower respiratory tract infections or sepsis."
In the case of patients with lower respiratory tract infection, the assay will aid physicians in their decision-making to safely reduce overall antibiotic use, the firm said, and added that with sepsis patients, the assay will aid physicians on deciding when they can safely discontinue antibiotic treatment.
Procalcitonin is a protein associated with the body’s response to a bacterial infection.
Clinicians’ decisions may be aided by BioMérieux's assay’s ability to detect high levels of PCT, which may indicate that a patient has a bacterial infection, the FDA said in a separate announcement. Similarly, a low level of PCT may indicate that the patient does not have an infection or that the infection is viral.
With antibiotic-resistant infections on the rise, the test may help clinicians make better antibiotic treatment decisions, said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, in a statement.
Sepsis can be part of the body’s response to an infection and can lead to tissue damage, organ failure, and death. Lower respiratory tract infections include community-acquired pneumonia, acute bronchitis, and acute exacerbations of chronic obstructive pulmonary disease. Bacteria often cause sepsis and lower respiratory tract infections, but viruses — particularly for lower respiratory tract infections — and non-infectious diseases can cause similar symptoms, the FDA said.
The FDA had already cleared the Vidas Brahms test for marketing through the 510(k) pathway to help clinicians better predict a patient’s risk of dying or becoming sicker due to sepsis.
Data supporting the test’s expanded use included clinical trial findings from published literature that compared PCT-guided therapy to standard therapy. Data from these prospective, randomized studies showed a significant decrease in antibiotic use for patients who had received PCT-guided therapy, without significantly affecting safety, the FDA said.
The Vidas Brahms test is intended to be used in the hospital or emergency room. The FDA said that healthcare providers should not rely solely on PCT test results when making treatment decisions, but "should interpret test results in the context of a patient’s clinical status and other laboratory results".