Renflexis™ is Latest Addition to Therapeutic Drug Monitoring by Miraca Life Sciences

IRVING, Texas, October 16, 2017 — Miraca Life Sciences, the largest U.S. independent anatomic pathology laboratory, continues to expand in clinical pathology: its InformTx™ therapeutic drug monitoring (TDM) has begun the validation process for Renflexis™ (infliximab-abda), a biosimilar of Remicade® (infliximab). Testing will be commercially available in early November. Since launching the InformTx service in June 2016, Miraca Life Sciences has expanded its TDM testing to now eight biologic drugs that treat inflammatory bowel disease (IBD).

In the United States, InformTx is the only TDM (with anti-drug antibodies) available for Inflectra® (infliximab-dybb), Cimzia® (certolizumab pegol), Stelara® (ustekinumab), and Simponi® (golimumab). Miraca Life Sciences also continues to offer TDM for Remicade, 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. Testing measures the level of the specified drug as well as patient-derived antibodies to the specified drug. Miraca Life Sciences uses laboratory-validated ELISA technology for InformTx TDM, and testing results are reported within five days.

“Since more drugs are becoming available to treat patients with IBD, Miraca Life Sciences will continue to seek therapeutic drug monitoring options for our clinician colleagues,” said Richard Lash, MD, Chief Medical Officer and Executive Vice President of Operations for Miraca Life Sciences. “Understanding patients’ drug and anti-drug antibody status is critical to guiding optimal care.”

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 eight 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, disease-focused projects, 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. Avista Capital Partners has agreed to acquire Miraca Life Sciences from Miraca Holdings Inc., and the transaction is expected to close in the fourth quarter of 2017. For more information, visit www.MiracaLifeSciences.com.

Renflexis is a trademark of Merck. Inflectra is a registered trademark of Pfizer Inc. 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.

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