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Prometheus Diagnostic Test Validated in Anticipation of U.S. Healthcare Provider Demand for Celltrion's INFLECTRA™ (Biosimilar Infliximab)

Anti-TNF Monitoring Test PROMETHEUS® Anser® IFX Demonstrates Equivalence for Measuring INFLECTRA Serum Drug and Antidrug Antibody Levels

SAN DIEGO, April 7, 2016 /PRNewswire/ -- 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 (FDA) and will be commercialized in the U.S. by Pfizer Inc.

"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.

About Prometheus

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.

About Nestle´ Health Science

Nestlé Health Science, a wholly-owned subsidiary of Nestlé, is a health-science company engaged in advancing the role of nutritional therapy to change the course of health for consumers, patients, and its partners in healthcare. Nestlé Health Science's portfolio of nutrition solutions, diagnostics, devices, and drugs targets a number of health areas, such as inborn errors of metabolism, pediatric and acute care, obesity care, healthy aging as well as gastrointestinal and brain health. Through investing in innovation and leveraging leading edge science, Nestlé Health Science brings forward innovative nutritional therapies with clinical, health economic value, and quality of life benefits. Nestlé Health Science employs around 3,000 people worldwide and is headquartered in Epalinges (near Lausanne), Switzerland. For more information, please visit:www.nestlehealthscience.com.

Remicade is a registered trademark of Janssen Biotech, Inc. All other trademarks used herein are trademarks of their respective owners.

Contact: Geri Vena-Shores
Telephone: 630-485-0965
Email: geri.venashores@prometheuslabs.com
Website: www.prometheuslabs.com

SOURCE Prometheus Laboratories Inc.

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http://www.prometheuslabs.com

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