Test Catalog

Test Id : VEDOL

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Vedolizumab Quantitation with Reflex to Antibodies, Serum

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Assessing the response to therapy with vedolizumab

 

An aid to achieving desired trough serum concentration of vedolizumab

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

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

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Vedolizumab quantitation will be performed by liquid chromatography-mass spectrometry on all samples. When this test is ordered and vedolizumab results are 15.0 mcg/mL or less, then testing for antibodies to vedolizumab will be performed at an additional charge.

 

This test includes vedolizumab drug quantitation and, if appropriate, antibody testing for antibodies-to-vedolizumab will be performed. Currently, the American Gastroenterology Association does not have a formal guideline on optimal thresholds for vedolizumab trough concentrations in the setting of loss of response to therapy, but trough concentrations greater than 12 mcg/mL to 15 mcg/mL have been associated with clinical or endoscopic remission and mucosal healing in inflammatory bowel disease.

 

For more information see Ulcerative Colitis and Crohn Disease Therapeutic Drug Monitoring Algorithm.

Method Name
A short description of the method used to perform the test

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

VEMAB: Electrochemiluminescent Bridging Immunoassay

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Vedolizumab QN, S

Aliases
Lists additional common names for a test, as an aid in searching

Vedolizumab

VEDO

Entyvio

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Vedolizumab quantitation will be performed by liquid chromatography-mass spectrometry on all samples. When this test is ordered and vedolizumab results are 15.0 mcg/mL or less, then testing for antibodies to vedolizumab will be performed at an additional charge.

 

This test includes vedolizumab drug quantitation and, if appropriate, antibody testing for antibodies-to-vedolizumab will be performed. Currently, the American Gastroenterology Association does not have a formal guideline on optimal thresholds for vedolizumab trough concentrations in the setting of loss of response to therapy, but trough concentrations greater than 12 mcg/mL to 15 mcg/mL have been associated with clinical or endoscopic remission and mucosal healing in inflammatory bowel disease.

 

For more information see Ulcerative Colitis and Crohn Disease Therapeutic Drug Monitoring Algorithm.

Specimen Type
Describes the specimen type validated for testing

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
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

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)

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.75 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

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

Useful For
Suggests clinical disorders or settings where the test may be helpful

Assessing the response to therapy with vedolizumab

 

An aid to achieving desired trough serum concentration of vedolizumab

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Vedolizumab quantitation will be performed by liquid chromatography-mass spectrometry on all samples. When this test is ordered and vedolizumab results are 15.0 mcg/mL or less, then testing for antibodies to vedolizumab will be performed at an additional charge.

 

This test includes vedolizumab drug quantitation and, if appropriate, antibody testing for antibodies-to-vedolizumab will be performed. Currently, the American Gastroenterology Association does not have a formal guideline on optimal thresholds for vedolizumab trough concentrations in the setting of loss of response to therapy, but trough concentrations greater than 12 mcg/mL to 15 mcg/mL have been associated with clinical or endoscopic remission and mucosal healing in inflammatory bowel disease.

 

For more information see Ulcerative Colitis and Crohn Disease Therapeutic Drug Monitoring Algorithm.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

VEDOLIZUMAB QUANTITATION:

Vedolizumab lower limit of quantitation: 2.0 mcg/mL

 

VEDOLIZUMAB ANTIBODIES:

Antibodies to vedolizumab: <9.8 ng/mL

Interpretation
Provides information to assist in interpretation of the test results

The limit of quantitation of the test is 2.0 mcg/mL. In a retrospective Mayo Clinic study with 171 patients (62% Crohn disease, 31% ulcerative colitis, and 7% indeterminate colitis), the median vedolizumab trough concentration was 15.3 mcg/mL.(11) Trough (immediately before next infusion) therapeutic concentrations of vedolizumab are expected to be above 15 mcg/mL.

 

Vedolizumab concentration greater than 15 mcg/mL at trough is associated with clinical remission, endoscopic remission, or mucosal healing in inflammatory bowel disease.

 

Clinically significant antibodies-to-vedolizumab impact drug clearance and are associated with low (< or =15 mcg/mL at trough) or undetectable vedolizumab concentration.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Patients actively undergoing therapy with both vedolizumab and nivolumab (rare scenario) should not have their therapeutic vedolizumab concentration assessed using this test. If the patient has taken nivolumab in the past, they should wait for 4 weeks after therapy with nivolumab has ended before being tested for vedolizumab quantitation using this method.

 

The presence of high concentrations of vedolizumab might inhibit the antibodies to vedolizumab (ATV) assay yielding false-negative results. In patients with concentrations of vedolizumab greater than 15.0 mcg/mL, the presence of an ATV is of little clinical significance.

 

Samples containing more than 100 ng/mL biotin (vitamin B7) may interfere (in the form of depressed signal) with VEMAB / Vedolizumab Antibodies, Serum.

 

Clinical management decisions for patients receiving vedolizumab treatment should not be based solely on quantitation of vedolizumab and assessment of ATV if appropriate. Test results must be interpreted within the clinical context of the patient.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Feagan BG, Rutgeerts P, Sands BE, et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013;369:699-710

2. Williet N, Boschetti G, Fovet M, et al. Association between low trough levels of vedolizumab during induction therapy for inflammatory bowel diseases and need for additional doses within 6 months. Clin Gastroenterol Hepatol. 2017;15(11):1750-1757.e3

3. Dreesen E, Verstockt B, Bian S, et al. Evidence to support monitoring of vedolizumab trough concentrations in patients with inflammatory bowel diseases. Clin Gastroenterol Hepatol. 2018;16(12):1937-1946 e8

4. Ungar B, Kopylov U, Yavzori M, et al. Association of vedolizumab level, anti-drug antibodies, and alpha4beta7 occupancy with response in patients with inflammatory bowel diseases. Clin Gastroenterol Hepatol. 2018;16(5):697-705.e7

5. Ward MG, Sparrow MP, Roblin X. Therapeutic drug monitoring of vedolizumab in inflammatory bowel disease: Current data and future directions. Therap Adv Gastroenterol. 2018;11:1756284818772786

6. Pouillon L, Rousseau H, Busby-Venner H, et al. Vedolizumab trough levels and histological healing during maintenance therapy in ulcerative colitis. J Crohns Colitis. 2019;13(8):970-975

7. Pouillon L, Vermeire S, Bossuyt P. Vedolizumab trough level monitoring in inflammatory bowel disease: A state-of-the-art overview. BMC Med. 2019;17(1):89

8. Singh S, Dulai PS, Vande Casteele N, et al. Systematic review with meta-analysis: Association between vedolizumab trough concentration and clinical outcomes in patients with inflammatory bowel diseases. Aliment Pharmacol Ther. 2019;50(8):848-857

9. Ungaro RC, Yarur A, Jossen J, et al. Higher trough vedolizumab concentrations during maintenance therapy are associated with corticosteroid-free remission in inflammatory bowel disease. J Crohns Colitis. 2019;13(8):963-969

10. Yarur AJ, Bruss A, Naik S, et al. Vedolizumab concentrations are associated with long-term endoscopic remission in patients with inflammatory bowel diseases. Dig Dis Sci. 2019;64(6):1651-1659

11. Al-Bawardy B, Ramos GP, Willrich MAV, et al. Vedolizumab drug level correlation with clinical remission, biomarker normalization, and mucosal healing in inflammatory bowel disease. Inflamm Bowel Dis. 2019;21;25(3):580-586

Method Description
Describes how the test is performed and provides a method-specific reference

Vedolizumab Quantitation:

Vedolizumab is extracted from serum and measured by liquid chromatography (high-resolution accurate-mass, HRAM) mass spectrometry.(Cradic KW, Ladwig PM, Rivard AL, Katrangi W, Wintgens KF, Willrich MAV. Vedolizumab quantitation using high-resolution accurate mass-mass spectrometry middle-up protein subunit: Method validation. Clin Chem Lab Med. 2020;58[6]:864-872)

 

Vedolizumab Antibodies:

Testing for antibodies to vedolizumab is carried out  using a laboratory-developed immunoassay on an electrochemiluminescence (Mesoscale Discovery) platform.(Unpublished Mayo method)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday, Wednesday, Thursday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

5 to 7 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

80280

82397 (if appropriate)

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
VEDOL Vedolizumab QN, S 90805-3
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
602807 Vedolizumab QN, S 90805-3

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | PHP Pdf | CMS Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports