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