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.