PROMETHEUS® Anser® VDZ Test Validated For Use

12 October 2016

New Test for Patients Treated With Vedolizumab (Takeda’s ENTYVIO®)

San Diego, CA October 12, 2016 – Prometheus Laboratories Inc. announced today the successful completion of the validation of the new PROMETHEUS Anser VDZ test for use in adult patients treated with vedolizumab in the management of moderate to severe active ulcerative colitis and Crohn’s disease.

“PROMETHEUS Anser VDZ uniquely measures both serum drug concentrations and antidrug antibody levels of vedolizumab from a single serum sample that may be obtained at any time during treatment,” said Tharak Rao, Vice President and Chief Medical Officer at Prometheus Laboratories Inc.  “PROMETHEUS Anser VDZ is a drug-tolerant assay that overcomes the limitations of assays that cannot measure both serum drug concentrations and antidrug antibody levels, even in the presence of vedolizumab.”

PROMETHEUS Anser VDZ is the latest addition to a comprehensive portfolio of monitoring tests that began with the introduction of PROMETHEUS Anser IFX in 2012. “Nearly 100,000 patient experiences with the PROMETHEUS Anser tests have been completed to date,” added Rao.  “PROMETHEUS Anser VDZ is a new monitoring test that helps healthcare providers optimize clinical response to vedolizumab in adult patients with inflammatory bowel disease (IBD).”  PROMETHEUS Anser tests provide important information that may help guide management decisions, whether clinicians are treating IBD patients with vedolizumab or anti-TNF agents, including infliximab, infliximab biosimilars, and adalimumab.

Vedolizumab was approved by the United States (U.S.) Food and Drug Administration in 2014 (under the brand name ENTYVIO) and is being commercialized in the U.S. by Takeda Pharmaceuticals U.S.A, Inc.

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.

PROMETHEUS and Anser are registered trademarks of Société des Produits Nestlé S.A. Vevey, Switzerland.  ENTYVIO is a registered trademark of Millennium Pharmaceuticals Inc.  INFLECTRA is a registered trademark of Hospira, a Pfizer Company.

- Prometheus Press release