InformTx Therapeutic Drug Monitoring


Make Evidence-Based Treatment Decisions

Use InformTx therapeutic drug monitoring (TDM) assays for Remicade®, Humira®, Cimzia®, Entyvio®, Stelara®, Simponi®, and Inflectra® in patients with inflammatory bowel disease (IBD).

What is InformTx?

InformTx therapeutic drug monitoring (TDM) assays measure both drug and anti-drug antibody levels in a patient’s blood.

InformTx assays are available for seven biologic drugs used to treat IBD.

  • Remicade® (infliximab)
  • Humira® (adalimumab)
  • Cimzia® (certolizumab pegol)
  • Entyvio® (vedolizumab)
  • Stelara® (ustekinumab)
  • Simponi® (golimumab)
  • Inflectra® (infliximab-dyyb) (Pending availability—US Validation in Progress)

How does InformTx therapeutic drug monitoring work?

InformTx testing uses laboratory-validated ELISA technology. Unique for TDM in the United States, the InformTx report gives you easy-to-interpret results:

InformTx TDM requires five to seven milliliters of peripheral blood in a serum separator tube, and the results are reported within five business days.

Watch our helpful InformTx videos

What is Therapeutic Drug Monitoring? Why Order TDM?

InformTx helps you maximize the efficacy of biologic therapy. Use for all of your IBD patients—whenever you need therapeutic guidance.

  • Optimize at induction to ensure therapeutic drug levels
  • Monitor during maintenance to track drug and anti-drug antibody (ADAb) levels
  • Manage at loss of response/no response to identify reason

Many factors influence individual patient response to biologic therapy:

  • Systemic inflammation
  • Other drug therapies
  • Pharmacogenetic factors
  • Disease phenotype
  • Body mass
  • Immunogenicity
  • Immunomodulators
  • Presence of anti-drug antibodies

Individual response to biologic drugs varies greatly. Variability by patients leads to four patient types: responders, initial responders, partial responders, and non-responders. InformTx enables clinicians to manage all patient types, across seven different biologic drugs used to treat IBD.

Who is billed for InformTx testing?

Insurance is billed for the testing and the patient will owe the amount that is not covered.

CPT codes can be presented to patient’s insurance company to attain an estimation of coverage:
 CPT codes for all biologics include: 80299 (drug) 83520 (antibody).

The clinician’s practice can be billed if a contract is set up with Miraca Life Sciences to bill the practice. Please contact or call 844.305.2166 for more information.

Does Miraca Life Sciences offer assistance programs for billing?

Yes, for TDM testing, patients can apply for assistance programs (payment plans and discounts if needed). A hardship form will need to be completed before the case is received. The hardship form cannot be completed until after an invoice is sent to the patient.

Please contact or call 844.305.2166 for more information.

Ready to Order InformTx Testing?

InformTx testing can be ordered by physicians and other clinicians. Patients who are interested in InformTx therapeutic drug monitoring should contact their healthcare provider to discuss if TDM is right for them.

Clinician Set-Up

Contact a Miraca Life Sciences Client Services Advocate to order InformTx requisitions and collection kits, at no cost to your practice.

Miraca Client Services Contact Information

Phone: 844.305.2166
Fax: 866.688.3280

Questions? Contact our Client Services Advocates or your Miraca sales representative.