Prometheus Launches New Adalimumab Drug And Antibody Levels Monitoring Test

Prometheus Laboratories Inc., a specialty pharmaceutical and diagnostic company, announced today the US market launch of its proprietary new test, PROMETHEUS® Anser™ ADA.  This novel test measures drug (adalimumab) and drug antibody levels in one serum sample in inflammatory bowel disease (IBD) patients using adalimumab (ADA) – helping physicians identify potential causes for loss of treatment response and thus help guide patient management decisions. PROMETHEUS Anser ADA, which utilizes Prometheus’ proprietary homogenous mobility shift assay, follows the July 2012 introduction of PROMETHEUS Anser IFX to further expand the line of tests that target biologic agents being used to treat a variety of autoimmune diseases.

The Crohn’s and Colitis Foundation of America estimates that approximately 1.4 million Americans suffer from IBD.  Many of these patients will use a biologic treatment like adalimumab to manage and control the symptoms of their disease.  Over time, however, these biologic agents may lose their effectiveness, resulting in increased disease activity and high discontinuation rates. This loss of treatment response is typically the result of: (1) insufficient drug levels, or (2) the development of antibodies to the biologic agent itself.

Recent clinical studies suggest that as many as 44 percent of IBD patients who have lost response to adalimumab have antibodies to the drug.1 If a patient loses treatment response to ADA, the most common first step for physicians is dose escalation, however depending on the mechanism of the loss of response, this may result in exposure of the patient to unneeded high drug doses and unnecessary expense.

“PROMETHEUS Anser ADA marks the latest milestone in our ongoing commitment to developing diagnostics to help guide personalized treatment decisions for gastroenterologists, patients and healthcare providers,” said Anthony Yost , Chief Commercial Officer of Prometheus.  “As the gastrointestinal healthcare community continues to further understand the long-term use of biologic agents in treating diseases like IBD, the need for comprehensive diagnostic tests like PROMETHEUS Anser ADA and PROMETHEUS Anser IFX becomes more critical, as does the value these novel assays offer in terms of time and expense saved when response to adalimumab or infliximab is lost.”

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About the author

Rob is a Senior Editor for the Morning Ledger.