IRVING, Texas--(BUSINESS WIRE)--Miraca Life Sciences, the largest U.S. independent anatomic pathology laboratory, continues to expand its InformTx™ therapeutic drug monitoring (TDM) capabilities, now testing for Simponi (golimumab) as well as patient-developed antibodies to Simponi. This is the first TDM assay available in the United States for Simponi. With this addition, Miraca Life Sciences now performs TDM for six biologic drugs that treat inflammatory bowel disease (IBD).
InformTx also is the only TDM (with anti-drug antibodies) available in the United States for Cimzia® (certolizumab pegol) and Stelara® (ustekinumab). The company also continues to offer TDM for Remicade® (infliximab), Humira® (adalimumab), and Entyvio® (vedolizumab).
The InformTx report is unique in that it provides clinicians with quantitative test results, historical test result data, and guidance from the most up-to-date peer-reviewed scientific literature. Miraca Life Sciences uses laboratory-validated ELISA technology for InformTx TDM, and testing results are reported within five days.
“Monitoring of therapeutic drug levels and anti-drug antibodies is extremely important for the effective management of inflammatory bowel disease,” said Richard Lash, MD, Chief Medical Officer and Executive Vice President of Operations for Miraca Life Sciences. “With our InformTx offering now encompassing six drugs, Miraca Life Sciences can serve even more gastroenterologists and their patients.”
Why Therapeutic Drug Monitoring?
Therapeutic drug monitoring is utilized by physicians to monitor an individual’s response to biologic drugs, as they vary greatly from patient to patient. Factors influencing individual patient response to biologic therapy include systemic inflammation, other drug therapies, pharmacogenetic factors, disease phenotype, body mass, immunogenicity, immunomodulators, and the presence of anti-drug antibodies. Variability by patients leads to four patient types: responders, initial responders, partial responders, and non-responders. InformTx enables clinicians to manage all patient types, and is now capable of evaluating six different biologic drugs used to treat IBD.
About Miraca Life Sciences
Miraca Life Sciences provides proven high-quality anatomic and clinical pathology services, focusing on the fields of gastroenterology, dermatology, hematology, urology, and breast health. The company’s team of more than 80 distinguished subspecialist pathologists utilizes state-of-the-art laboratories to serve more than 5,500 patients every day. Miraca Life Sciences’ difference is based on consensus-based medicine (including comprehensive sub-subspecialization, unified terminology and criteria, daily consensus conferences, and extensive educational activities), rigorous quality assurance, active clinical research, innovation in testing, technological advancements, and health IT consulting services for clinician clients. Headquartered in Irving, Texas, Miraca Life Sciences is a subsidiary of Miraca Holdings Inc., one of Japan’s largest clinical diagnostics and laboratory testing service providers. For more information, visit www.MiracaLifeSciences.com.
Simponi, Stelara and Remicade are registered trademarks of Janssen Biotech, Inc. Humira is a registered trademark of AbbVie Inc. Cimzia is a registered trademark of UCB. Entyvio is a registered trademark of Millennium Pharmaceuticals Inc.