Miraca Life Sciences Again Expands Therapeutic Drug Monitoring with Addition of First Biosimilar Inflectra®

IRVING, Texas–(BUSINESS WIRE)–Miraca Life Sciences, the largest U.S. independent anatomic pathology
laboratory, has further expanded its InformTx™
therapeutic drug monitoring
(TDM) capabilities with the addition of
testing for Inflectra® (infliximab-dyyb), which is the first biosimilar
drug in the test offering. Since launching InformTx in June 2016, Miraca
Life Sciences has expanded the service from four to now seven biologic
drugs that treat inflammatory bowel disease (IBD).

In the United States, InformTx is the only TDM (with anti-drug
antibodies) available for Cimzia® (certolizumab pegol), Stelara®
(ustekinumab), and Simponi® (golimumab). The company also continues to
offer TDM for Remicade® (infliximab), Humira® (adalimumab), and Entyvio®

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 Inflectra as well as patient-developed antibodies
to Inflectra. Miraca Life Sciences uses laboratory-validated ELISA
technology for InformTx TDM, and testing results are reported within
five days.

“The addition of a biosimilar drug to our InformTx therapeutic drug
monitoring gives clinicians who treat IBD patients with the biosimilar
Inflectra® the same critical information as with other biologics,” 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 seven
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
reviews, 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.

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.


Miraca Life Sciences
Joy Jennings, 214-596-7055
Director of