Anti-TNF Monitoring Test PROMETHEUS® Anser® IFX Demonstrates
Equivalence for Measuring Inflectra Serum Drug and Antidrug Antibody
San Diego, CA April 7, 2016 – Prometheus Laboratories Inc. announced today
that the PROMETHEUS Anser IFX test has been validated for use in patients
treated with Inflectra (biosimilar infliximab) in the management of inflammatory
bowel disease (IBD). Validation was demonstrated using specimens from
Inflectra-treated patients with IBD.
Inflectra — a biosimilar of the U.S. reference product, Remicade® — was recently
approved by the United States (U.S.) Food and Drug Administration and will be
commercialized in the U.S. by Pfizer.
“Our data indicate that healthcare providers can confidently use the
PROMETHEUS Anser IFX test, which uniquely measures both serum drug and
antidrug antibody levels in the presence of Inflectra (biosimilar infliximab) or
Remicade (infliximab) from a single serum sample obtained at any time during
treatment,” said Tharak Rao, Vice President and Chief Medical Officer at
Prometheus Laboratories Inc. “The PROMETHEUS Anser IFX test provides
critical information that may help a healthcare provider optimize an IBD patient’s
clinical response to biosimilar infliximab or Remicade.”
Equivalence testing was completed so that healthcare professionals can
immediately begin using the PROMETHEUS Anser IFX test to monitor their IBD
patients on Inflectra.
Prometheus Laboratories Inc. is committed to improving lives through the
development and commercialization of novel pharmaceutical and diagnostic
products that enable physicians to provide greater individualized patient care.
Prometheus is a leader in applying the principles of personalized medicine to the
diagnosis and treatment of gastrointestinal diseases and is applying these
principles to oncology. Its strategy includes the marketing and delivery of
pharmaceutical products complemented by proprietary diagnostic testing
services. By integrating therapeutics and diagnostics, Prometheus believes it
can provide physicians with more targeted solutions to optimize care for their
patients. Prometheus became part of Nestlé Health Science in July 2011.
Prometheus' corporate offices are located in San Diego, California. For more
information about Prometheus, please visit www.prometheuslabs.com.
Remicade is a registered trademark of Janssen Biotech, Inc. All other
trademarks used herein are trademarks of their respective owners.
- Press release