VEDOLIZUMAB LEVEL W/ABS

Test Code

LAB3922

Quest Code

36517

CPT Codes
80280, 83520

Preferred Specimen

1.5 mL serum

Patient Preparation
1. For 12 hours before this test do not take multivitamins or dietary supplements containing biotin (vitamin B7), which is commonly found in hair, skin, and nail supplements and multivitamins.
2. Nivolumab (Opdivo) must be discontinued at least 4 weeks prior to testing for vedolizumab quantitation in serum.

Minimum Volume

0.75 mL

Instructions

1. Draw immediately before next scheduled dose (trough specimen).
2. Centrifuge within 2 hours of draw

Transport Container

Transport tube

Transport Temperature

Refrigerated (cold packs)

Specimen Stability

Room temperature: Unacceptable
Refrigerated: 28 days
Frozen: 28 days

Methodology
Liquid Chromatography/Mass Spectrometry (LC/MS) • Electrochemiluminescent Bridging Immunoassay

FDA Status
This test was developed and its performance characteristics have been determined by Mayo Clinic Laboratories. It has not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

Vedolizumab Quant: Mon, Thurs; Vedolizumab Abs: Tues, Fri

Report Available

14 days

Reference Range

See Laboratory Report

Clinical Significance

Vedolizumab (Entyvio) is a humanized monoclonal antibody directed against integrin alpha-4 beta-7. Blocking the alpha-4 beta-7 integrin results in a gut-selective anti-inflammatory response. The drug is FDA-approved for the treatment of adult patients with moderately to severely active ulcerative colitis or Crohn disease. Although optimal therapeutic concentrations of vedolizumab are not well known, Mayo Clinic Gastroenterologists are working to correlate drug concentrations with patient outcomes. Vedolizumab testing will assess the patients loss of response to therapy, similar to therapy received using tumor necrosis factor (TNF) inhibitors, such as infliximab and adalimumab. Some patients on vedolizumab may develop antibodies to vedolizumab (ATV) over time. In clinical trials, approximately 4% of patients treated with vedolizumab were positive for ATV at any time and 1% or less were persistently positive. Therefore, simultaneous testing for measurement of ATV is recommended. ATV uses a bridging immunoassay on an electrochemiluminescence (Mesoscale Discovery) platform.

Performing Laboratory

Mayo Clinical Laboratories

3050 Superior Drive NW

Rochester, MN 55901

Last Updated: February 8, 2022

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.