FDA clears Fujirebio PCT assay

Fujirebio Diagnostics has received FDA clearance for a new procalcitonin, or PCT, assay to be used on its Lumipulse G1200 immunoassay platform, the company announced.

According to the announcement, when used in conjunction with other laboratory findings and clinical assessments, the Lumipulse G BRAHMS PCT assay can aide physicians in making decisions for patients with suspected or confirmed lower respiratory tract infection (LRTI) or sepsis. It can also help them:

assess the risk of critically ill patients on their first day of ICU admission for progression to severe sepsis or septic shock; and
assess the cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock in the ICU, or obtained in the ED or other hospital setting before ICU admission, by measuring a change in PCT level over time.

PCT is a biomarker in blood that distinguishes bacterial infections from viral infections, helping physicians guide antibiotic treatment.

Past research showed that PCT testing on the first day of ICU care is associated with lower costs and reduced lengths of hospital stay. Surprisingly, however, results of a recently published study showed that PCT-based guidance did not have a significant impact on antibiotic use compared with standard care in patients who presented to an ED for suspected LRTI.

Reference:

Fujirebio Diagnostics announces FDA clearance of Lumipulse G BRAHMS PCT assay. https://www.fujirebio-us.com/media-and-events/news/2018/fujirebio-diagnostics-announces-fda-clearance-lumipulse-g-brahms-pct. Accessed June 13, 2017.