Beckman Coulter’s Procalcitonin Assay Cleared

Beckman Coulter’s Access PCT (procalcitonin) diagnostic has received 510(k) clearance from the FDA.

The assay is designed for assessing severely ill patients at risk of progressing to severe sepsis or septic shock. It  produces test results in under 20 minutes.

“Procalcitonin levels in blood have been found to correlate with the severity of bacterial infections … making it a clinically useful marker in the assessment of patients with possible sepsis or at risk of progressing to septic shock,” said the company’s CMO Shamiram Feinglass.