Skyrizi
***Test is NOT available for Outreach clients, but is available to MMC-Dickinson.***
Serum risankizumab (RZB) concentration, Antibodies to Risankizumab (ATR) concentration
The Anser® RZB test is a quantitative therapeutic drug monitoring (TDM) assay that allows healthcare providers to measure and monitor serum risankizumab (RZB) and antibodies-to-risankizumab (ATR) levels at any time during therapy.
Send ambient or cold pack. Do not freeze.
This test was developed and its performance characteristics determined by Prometheus Laboratories, CAP-accredited (6805501) and CLIA-certified (05D0917432) as qualified to perform high complexity testing. It has not been cleared or approved by the US Food and Drug Administration
The Anser® RZB test is a quantitative therapeutic drug monitoring (TDM) assay that allows healthcare providers to measure and monitor serum risankizumab (RZB) and antibodies-to-risankizumab (ATR) levels at any time during therapy.
Serum concentrations of RZB may vary among equally dosed patients which can ultimately affect patient outcomes. In adult Crohn's disease (CD) patients, an exposure-response relationship was observed for RZB with significantly higher mean serum RZB concentrations in cases of clinical and biochemical remission than in the absence of remission (p=0.001). ATR development can associate with lower RZB concentrations, reduced clinical response, hypersensitivity and infusion site reactions. Therefore, the quantitative measurement of RZB and ATR levels in serum provides valuable information to healthcare providers to better assess a patient's risk or reason for losing response to RZB and helps them decide an appropriate course of action.
Serum Risankizumab Lower Limit of Quantification: < 0.5 ug/mL
Antibodies to Risankizumab Lower Limit of Quantification: < 3.5 U/mL