FDA Approves Procalcitonin Biomarker Test to Aid Antibiotic Decision Making
High levels of procalcitonin suggest a patient has a bacterial infection.
The U.S. Food and Drug Administration (FDA) has expanded the use of the Vidas Brahms PCT Assay (bioMérieux) to help clinicians make important decisions regarding the optimal use of antibiotics in two common clinical situations: lower respiratory tract infections (LRTI) and sepsis. This is the first test to use procalcitonin (PCT) as a biomarker to help make antibiotic management decisions in patients with these conditions. The test is intended to be used in the hospital or emergency room.
High levels of PCT suggest a patient has a bacterial infection; however, while PCT may indicate the presence of bacterial infections, it does not detect the exact cause of a patient's symptoms. Low levels of PCT suggest a viral infection or non-infectious causes. Clinicians should not rely solely on PCT test results alone when making treatment decisions, as false positive result can occur. Test results should be interpreted in the context of a patient's clinical status and other laboratory results.
Data supporting the test's expanded use included clinical trial findings that compared PCT-guided therapy to standard therapy. Results from these prospective, randomized studies showed a significant decrease in antibiotic use for patients who had received PCT-guided therapy, without significantly affecting safety.
“Measuring PCT at clinical presentation and serially over 4 days will provide clinicians with high medical value information to help them identify patients who are at greatest risk of mortality and ultimately can result in improved, more targeted and intensified patient care and better medical outcomes," said Mark Miller, Chief Medical Officer at bioMérieux.
In 2007, the FDA approved the Vidas Brahms test as the first automated test measuring PCT in the U.S. to aid in the risk assessment for sepsis and septic shock on the first day following admission to an intensive care unit. In June 2016, the test received an additional approval to aid in assessing the risk of mortality for patients with severe sepsis by monitoring PCT levels serially over 96 hours.
For more information visit www.Biomerieux.com.
FDA clears test to help manage antibiotic treatment for lower respiratory tract infections and sepsis [news release]. Silver Spring, MD: US Food and Drug Administration; February 23, 2017.