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Miraca launches therapeutic drug monitoring assays for IBD patients on biologics
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Miraca Life Sciences has announced the launch of its InformTx therapeutic drug monitoring assays for patients with inflammatory bowel disease.
These new assays measure drug and anti-drug antibody levels for Remicade (infliximab, Janssen) and Humira (adalimumab, AbbVie), and for the first time in the United States, Cimzia (certolizumab, UCB) and Entyvio (vedolizumab, Takeda), according to a press release.
“Miraca Life Sciences has designed InformTx for today’s busy gastroenterologists to help them with the challenging task of optimizing treatment of patients on biologics via easy-to-interpret results and clear, actionable guidance,” Frank Basile, MD, president and CEO of Miraca Life Sciences, said in the press release. “Through this clinical [therapeutic drug monitoring] testing, we offer new services to our clients and to the entire GI field in the United States.”
Therapeutic drug monitoring allows clinicians to personalize IBD management for patients who are responders, initial responders, partial responders or nonresponders to biologic therapies. This varies widely depending on factors like systemic inflammation, other drug therapies, pharmacogenetics factors, disease phenotype, body mass, immunogenicity, immunomodulators and anti-drug antibodies, according to the press release.
Miraca licensed the technology and raw materials for these assays from Theradiag, which markets them under the name Lisa Tracker in Europe. InformTx assays have been in use by a few physician practices since May 2, but are now available to gastroenterologists throughout the U.S.
The assays use laboratory-validated ELISA technology, require 5 to 7 mL of peripheral blood in a serum separator tube, and the results are reported within 5 days. The InformTx report includes quantitative test results, historical test result data and guidance from the latest peer-reviewed literature, which is unique to the United States market, according to the press release.
Disclosures: Basile is employed by Miraca Life Sciences.