FDA Expands Indication of Antibiotic Treatment Assay

The FDA recently expanded the indication of the Vidas Brahms PCT Assay to help healthcare providers decide whether antibiotic treatment should be started or stopped in patients with lower respiratory tract infections or sepsis.

This is the first test to use procalcitonin (PCT), a protein associated with the body’s response to bacterial infection, as a biomarker to guide antibiotic management in patients with these conditions, according to a press release.

The test measures PCT, which can help inform treatment options. High levels of PCT suggest a bacterial infection, while low levels suggest a viral infection or a non-infection, the FDA reported. This information can be used to withhold or stop antibiotic treatment safely.

Although PCT can indicate a bacterial infection, it does not determine the root cause of the symptoms.

Sepsis can be indicatory of a response to infection and can lead to adverse events, such as tissue damage, organ failure, and death. Lower respiratory tract infections include community-acquired pneumonia, acute bronchitis, and acute exacerbations of COPD. While bacteria can cause sepsis and lower respiratory tract infections, viruses and non-infectious diseases can elicit the same symptoms, according to the press release.

The Vidas Brahms test was approved through the 510(k) pathway, and was first cleared to help determine a patient’s risk of dying or progressing due to sepsis.

Clinical trials that compared PCT-guided therapy to standard therapy was the basis of the expanded indication. These findings showed that antibiotic use decreased among patients who received PCT-guided therapy without impacting safety, according to the FDA.

Risks associated with the Vidas Brahms test include false positive and false negative test results, which could lead to unnecessary treatment or a delay in appropriate treatment. The FDA advises the PCT test should be used in conjunction with a patient’s clinical status and other laboratory results.

Healthcare providers should review the test’s package insert for information regarding clinical use and performance, according to the press release.

“Unnecessary antibiotic use may contribute to the rise in antibiotic-resistant infections,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health. “This test may help clinicians make antibiotic treatment decisions.”