Miraca Life Sciences Launches InformTx™ Therapeutic Drug Monitoring for Four Biologic Drugs, Including Firsts for the United States

Inform Diagnostics, the nation’s largest independent anatomic pathology lab, has expanded into clinical pathology testing with its launch of InformTx therapeutic drug monitoring (TDM) for patients with inflammatory bowel disease (IBD). The InformTx assays measure both drug and anti-drug antibody levels for infliximab (trade name Remicade®), adalimumab (trade name Humira®), certolizumab (trade name Cimzia®), and vedolizumab (trade name Entyvio®). The launch of InformTx marks the first time that TDM has been available in the United States for certolizumab and vedolizumab. Inform Diagnostics licensed the technology and raw materials for InformTx from France-based Theradiag, which has offered these TDM assays in Europe for many years under the name LISA TRACKER.

InformTx testing uses laboratory-validated ELISA technology. Unique for TDM in the United States, the InformTx report provides clinicians with quantitative test results, historical test result data, and guidance from the most up-to-date peer-reviewed scientific literature. Testing requires five to seven milliliters of peripheral blood in a serum separator tube, and the results are reported within five days.

InformTx testing has been underway since May 2 with a few physician practices. The service is now available to all U.S.-based gastroenterologists.

Why Therapeutic Drug Monitoring?

Clinicians choose therapeutic drug monitoring for their patients because individual response to biologic drugs varies greatly. Factors influencing individual patient response to biologic therapy includes 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, across four different biologic drugs used to treat IBD.

“Inform Diagnostics 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,” said Dr. Frank Basile, President and CEO of Inform Diagnostics. “Through this clinical TDM testing, we offer new services to our clients and to the entire GI field in the United States.”

For more information about InformTx including ordering instructions, visit www.InformTx.com or call 1.844.305.2166.

About Inform Diagnostics

Inform Diagnostics provides the highest quality anatomic pathology services, primarily in the fields of dermatology, hematology, gastroenterology, urology, and breast health. The company also provides clinical pathology services for therapeutic drug monitoring of certain biologic drugs. The company’s team of more than 90 distinguished expert subspecialists utilizes state-of-the-art pathology laboratories to serve more than 5,500 patients every day. Inform Diagnostics continuously improves diagnostic precision through consensus-based terminology and criteria, rigorous quality assurance, daily consensus conferences, extensive educational and training activities, and close relationships with clinical partners. Headquartered in Irving, Texas, Inform Diagnostics Life Sciences is a subsidiary of Inform Diagnostics Holdings Inc., Japan’s largest clinical diagnostics and laboratory testing service provider. For more information, visit www.MiracaLifeSciences.com.

InformTx is a trademark of Inform Diagnostics. All other trademarks are the property of their respective owners.

Media contact information:
Joy Jennings, Director of Marketing
jjennings@MiracaLS.com
214.596.7055

Categories: Press