Sign in →

Test Code VEDOL Vedolizumab Quantitation with Reflex to Antibodies, Serum


Ordering Guidance


If both quantitation and antibody testing are needed, regardless of the quantitation results, order VEDOZ / Vedolizumab Quantitation with Antibodies, Serum.



Specimen Required


Patient Preparation:

1. For 12 hours before specimen collection, patient should not take multivitamins or dietary supplements (eg, hair, skin, and nail supplements) containing biotin (vitamin B7).

2. Nivolumab (Opdivo) must be discontinued at least 4 weeks prior to testing for vedolizumab quantitation in serum.

Collection Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 1.5 mL

Collection Instructions:

1. Draw blood immediately before next scheduled dose (trough specimen).

2. Centrifuge and aliquot serum into a plastic vial within 2 hours of collection.


Useful For

Assessing the response to therapy with vedolizumab

 

An aid to achieving desired trough serum concentration of vedolizumab

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
VEMAB Vedolizumab Ab, S No No

Method Name

VEDOL: Liquid Chromatography-Mass Spectrometry (LC-MS/MS)

VEMAB: Electrochemiluminescent Bridging Immunoassay

Reporting Name

Vedolizumab QN, S

Specimen Type

Serum

Specimen Minimum Volume

0.75 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 28 days
  Frozen  28 days

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Clinical Information

Vedolizumab (Entyvio) is a humanized IgG1 kappa monoclonal antibody directed against integrin alpha-4 beta-7. Blocking the alpha-4 beta-7 integrin results in a gut-selective anti-inflammatory response.(1) The drug is US Food and Drug Administration approved for the treatment of adult patients with moderately to severely active ulcerative colitis or Crohn disease. The main indication for therapeutic drug monitoring of vedolizumab is in the setting of primary nonresponse or loss-of-response to therapy, also called reactive monitoring.(2-10) Vedolizumab trough concentrations greater than 12 mcg/mL to 15 mcg/mL have been associated with clinical or endoscopic remission.(3,5,11) Proactive monitoring of vedolizumab concentrations has been proposed, but there is not sufficient data to support routine proactive testing at this time.

 

Therapeutic drug monitoring of biologics is usually carried out by measuring the monoclonal antibody therapy concentration and assessing its immunogenicity or the appearance of anti-drug antibodies. 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. Clinically significant ATV impact drug clearance and a positive ATV is associated with lower trough concentrations of vedolizumab.

Reference Values

VEDOLIZUMAB QUANTITATION:

Vedolizumab lower limit of quantitation: 2.0 mcg/mL

 

VEDOLIZUMAB ANTIBODIES:

Antibodies to vedolizumab: <9.8 ng/mL

Day(s) Performed

Monday, Wednesday, Thursday

Report Available

5 to 7 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

80280

82397 (if appropriate)

Forms

If not ordering electronically, complete, print, and send 1 of the following with the specimen:

-Gastroenterology and Hepatology Test Request (T728)

-Therapeutics Test Request (T831)