TGA Updates Instructions for Use for ADVIA Centaur Assays

Australia’s Therapeutic Goods Association is updating Siemens Healthcare Diagnostics’ Instructions for Use statement for its prostate-specific antigen assays used with ADVIA Centaur systems.

The update will clarify the utility of the PSA assay, the TGA said, noting that the ADVIA Centaur/XP/XPT PSA assay is intended to be used as an aid in detecting prostate cancer and in monitoring and managing prostate cancer patients.

The agency was advised that PSA measurements at values <0.2 ng/mL are being used to monitor some patients for biochemical recurrence of prostate cancer post-radical prostatectomy. The PSA assay should not be used to predict disease recurrence solely based on serial PSA values, the agency advised.