LabCorp's DoseASSURE test portfolio provides tests for both drug concentration (TDM) and anti-drug antibody (immunogenicity)
Inflammatory Bowel Disease (IBD) is a chronic disease impacting nearly 1.2 million Americans.1 Developments in treatment, such as biologics, have greatly improved quality of life for patients and advancements in laboratory testing are helping to support diagnosis and optimize therapy. LabCorp offers leading expertise and comprehensive testing services to support physicians in the management of IBD patients.
Biologics monitoring assays measure both drug concentration and anti-drug antibodies to support improved clinical outcomes and characterize those patients who may have diminished response to therapy.2, 3, 4, 5
DoseASSURE, LabCorp’s portfolio of biologics monitoring assays, may help physicians optimize biological therapy using a personalized, patient-specific approach.
Patient-specific clinical context must be taken into account when evaluating drug and anti-drug antibody. Serial measurements over time may be helpful.
Patient responsibility is determined by amount billed to patients after the insurance provider has been billed, including copay, coinsurance, deductible, or coverage denials. Based on managed care claim data** from 2018:
|503870||Infliximab and Anti-Infliximab Antibody, DoseASSURE™ IFX|
|503890||Adalimumab and Anti-Adalimumab Antibody, DoseASSURE™ ADL|
|504567||Vedolizumab and Anti-Vedolizumab Antibody, DoseASSURE™ VDZ|
|504563||Golimumab and Anti-Golimumab Antibody, DoseASSURE™ GOL|
|504594||Ustekinumab and Anti-Ustekinumab Antibody, DoseASSURE™ UST|
|504627||Certolizumab and Anti-Certolizumab Antibody, DoseASSURE™ CTZ|
|006627||C-Reactive Protein (CRP), Quantitative|
|183988||Clostridioides difficile Toxin Gene, NAA|
|005009||Complete Blood Count (CBC) With Differential|
|162020||Crohn's Disease Prognostic Profile|
|006510||Hepatitis B Surface Antigen (HBsAg) Screen, Qualitative|
|016881||Hepatitis B Core Antibody, IgM|
|162045||Inflammatory Bowel Disease (IBD) Expanded Profile|
|322000||Metabolic Panel (14), Comprehensive|
|005215||Sedimentation Rate, Modified Westergren|
|510750||Thiopurine Methyltransferase (TPMT), Enzyme Activity, Erythrocytes|
** Based on internal LabCorp billing data (2018).
† Includes claims adjudicated as non-covered and for which there was no patient responsibility indicated by the payer. The explanation of benefits (EOB) from the insurance company explains in detail the services that were either paid or denied. If a claim is denied, the patient is responsible for the amount indicated on the EOB the patient receives from the insurer. If further assistance is needed in determining the reason(s) why the insurance company did not pay for testing, patients should contact their insurance carrier directly. A listing of insurance plans billed by LabCorp can be found at www.labcorp.com.
Dotan I, Fishman S, Dgani Y, et al. Antibodies against laminariboside and chitobioside are novel serologic markers in Crohn’s disease. Gastroenterology. 2006;131:366-378.
Ferrante M, Liesbet H, Joossens M, et al. New serological markers in inflammatory bowel disease are associated with complicated disease behavior. Gut. 2007;56:1394-1403.
Papp M, Altorjay I, Dotan N et al. New serological markers for inflammatory bowel disease are associated with earlier age at onset, complicated disease behavior, risk for surgery, and NOD2/CARD15 genotype in a Hungarian IBD cohort. Am J Gastroenterol. 2008;103:665-681.
Jaskowski TD, Litwin CM, Hill HR. Analysis of serum antibodies in patients suspected of having inflammatory bowel fisease. Clin Vaccine Immunol. 2006;13(6):655-660.
Quinton J-F, Sendid B, Reumaux D, et al. Anti-saccharomyces cerevisiae mannan antibodies combined with antineutrophil cytoplasmic autoantibodies in inflammatory bowel disease: Prevalence and diagnostic role. Gut. 1998;42:788-791
Malickova K, Lakatos PL, Bortlik M, Komarek V, Janatkova I, Lukas M. Anticarbohydrate antibodies as markers of inflammatory bowel disease in Central European cohort. Eur J Gastroenterol Hepatol. 2010;22(2):144-150.
Chevaux JB, Peyrin-Biroulet L, Sparrow MP. Optimizing thiopurine therapy in inflammatory bowel disease. Inflamm Bowel Dis. 2011 Jun; 17(6): 1428-1435.
Clunie GPR, Lennard L. Relevance of thiopurine methyltransferase status in rheumatology patients receiving azathioprine. Rheumatol. 2004 Jan; 43(1):13-18.
Zhou S. Clinical pharmacogenomics of thiopurine S-methyltransferase. Curr Clin Pharmacol. 2006 Jan; 1(1):119-128.
IMURAN® (azathioprine) [package insert]. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016324s034s035l.... Accessed: January 27, 2016.
Vande Casteele N, et al. Trough Concentrations of Infliximab Guide Dosing for Patients With Inflammatory Bowel Disease. Gastroenter 2015;148:1320-1329.
Vaughn BP, et al. Proactive Therapeutic Concentration Monitoring of Infliximab May Improve Outcomes for Patients with Inflammatory Bowel Disease: Results from a Pilot Observational Study. Inflamm Bowel Dis 2014;20:1996-2003.
Vaughn BP, et al. Biologic Concentration Testing in Inflammatory Bowel Disease. Inflamm Bowel Dis 2015;21:1435-4142.
Ungar B, et al. The temporal evolution of antidrug antibodies in patients with inflammatory bowel disease treated with infliximab. Gut 2014;63:1258-1264.
American Gastroenterological Association. Guidelines for the Identification, Assessment and Initial Medical Treatment in Crohn’s Disease. https://www.gastro.org/IBDcarepathway
Steenholdt C, et al. Individualised therapy is more cost-effective than dose intensification in patients with Crohn’s disease who lose response to anti-TNF treatment: a randomised, controlled trial. Gut 2014;63:919-927.
Ordas, et al. Therapeutic Drug Monitoring of Tumor Necrosis Factor Antagonists in Inflammatory Bowel Disease. Clin Gastroenterol Hepatol 2012;10:1079-1087.
Steenholdt C, et al. Clinical Implications of Variations in Anti-infliximab Antibody Levels in Patients with Inflammatory Bowel Disease. Inflamm Bowel Dis 2012 Vol 18(12):2209-2217.