***Test is NOT available for Outreach clients, (but is available to MMC - Dickinson).***
Entyvio
To measure and monitor serum vedolizumab (VDZ) and antibodies-to-vedolizumab (ATV) 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® VDZ test is a quantitative therapeutic drug monitoring (TDM) assay that allows healthcare providers to measure and monitor serum vedolizumab (VDZ) and antibodies-to-vedolizumab (ATV) levels at any time during therapy.
Serum concentrations of vedolizumab (VDZ) may vary among equally dosed patients which can ultimately affect patient outcomes. Suboptimal levels of VDZ have been linked to lower response rates in IBD patients. Furthermore, some patients may develop immunogenicity to VDZ by producing ATV. The presence of ATV has also been associated with increased drug clearance and lower response rates. Therefore, the quantitative measurement of VDZ and ATV levels in serum provides valuable information to healthcare providers to better assess a patient's risk or reason for losing response to VDZ and helps them decide an appropriate course of action.
Serum vedolizumab (VDZ) Lower Limit of Quantification: < 1.6 ug/mL
Antibody to vedolizumab (ATV) Lower Limit of Quantification: < 1.6 U/mL