IRVING, Texas, October 16, 2017 — Inform Diagnostics 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, Inform Diagnostics 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). Inform Diagnostics
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. Inform Diagnostics 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,
Inform Diagnostics 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 Inform Diagnostics Life Sciences. “Understanding
patients’ drug and anti-drug antibody status is critical to guiding
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
About Inform Diagnostics Life Sciences
Inform Diagnostics 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.