Reflexive testing

Clinically significant antibodies to biologic therapies are found in patients with very low trough concentrations in their serum. Therefore, a reflexive approach, which performs testing only when it is clinically relevant, benefits patients and reduces costs for the ordering institution. When concentration results are below a specified level, testing for antibodies to the specific drug will be performed at an additional charge.

Key testing

• ADALX | Adalimumab Quantitative with Reflex to Antibody, Serum
• INFXR | Infliximab Quantitation with Reflex to Antibodies to Infliximab, Serum
• VEDOL | Vedolizumab Quantitation with Reflex to Antibodies, Serum

Advantages

• Facilitates understanding of treatment efficacy to assist providers in optimizing medication performance.
• Clarifies immunogenicity, enabling providers to adjust treatment plans accordingly.  

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Panel testing

For newer therapies such as ustekinumab that do not yet have well-established therapeutic thresholds and optimal concentrations associated with good outcomes, we offer testing that performs both quantitation and antibody testing on all specimens. We also offer this approach for infliximab and adalimumab therapies.

The panel approach may be considered if there is a known justification for performing both quantitation and anti-drug antibody reactivity. We offer a comprehensive menu of biologic testing for providers to order the right test for the patient at the right time. Offering a reflex test in addition to the panel provides versatility for physicians responding to patients’ needs. Furthermore, the panel will assist with proactive monitoring, which plays a significant role in helping some patients, such as the pediatric population, to manage IBD early in the treatment course.

Key testing

• ADALP | Adalimumab Quantitative with Antibody, Serum
• INFXP | Infliximab Quantitation with Antibodies to Infliximab, Serum
• RISAP | Risankizumab Quantitation with Antibodies, Serum
• USTEK | Ustekinumab Quantitation with Antibodies, Serum
• VEDOZ | Vedolizumab Quantitation with Antibodies, Serum

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Therapeutic monitoring

Our risankizumab panel includes two tests for patients who are prescribed this drug for conditions including psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The first test is a mass spectrometry-based assay to measure the concentration of the drug in patient serum. It’s an IgG kappa monoclonal antibody therapy that measures the signature light chain mass of risankizumab. The second is an antibody test that identifies the presence of anti-drug antibodies against the therapeutic monoclonal risankizumab. The antibody test is performed by a bridging immunoassay that is run on a chemiluminescence platform.

Key testing

• RISAP | Risankizumab Quantitation with Antibodies, Serum
  • Provides an accurate interpretation of drug quantitation that may aid in managing diagnosis, drug dosage, and treatment schedule.
  • Detects anti-drug antibodies using therapeutic drug monitoring.
  • Helps guide patient management by measuring circulating drug concentrations and assessing for antibodies to risankizumab (ATRs).

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Quantitation

We offer a mass spectrometry-based test to measure risankizumab concentrations in patients who are prescribed this drug for conditions including psoriasis, psoriatic arthritis, and Crohn's disease. This stand-alone test will help physicians identify loss of response to the therapy in patients, allowing the physician to increase or discontinue therapy as needed.

Key testing

• RISA | Risankizumab, Serum

Advantages

• Quantitates risankizumab in serum samples from 1 to 100 micrograms per mL, covering the trough and peak concentrations expected in all conditions for which risankizumab is prescribed.
• Assists providers in optimizing medication performance by providing insights into a patient’s response to treatment.
• Assesses the response to risankizumab therapy and the need for dose escalation.
• Evaluates the need for potential changes or discontinuation of therapy.
• Monitors patients who need to be above a certain risankizumab concentration to improve the odds of a clinical response for therapy optimization.