Analysis Group Work Supports Client's Successful Application for Groundbreaking Diagnostic Test to Improve Antibiotic Management
March 02, 2017
An Analysis Group team, led by Vice President Noam Kirson and Economist Philippe Thompson-Leduc, worked with bioMérieux to win approval from the US Food and Drug Administration (FDA) for expanded use of the medical testing company's automated assay for measuring procalcitonin (PCT) levels. With the two newly approved indications, bioMérieux's VIDAS® B•R•A•H•M•S test became the first and only PCT test to be cleared by the FDA for the US market for use with patients with lower respiratory tract infections (LRTI) or sepsis. The Analysis Group team also included Principal Howard Birnbaum, Senior Analyst Chris DeBrase, and Analyst Sophie Schonfeld.
The VIDAS® B•R•A•H•M•S test, which is intended to be used in the hospital or emergency room, makes use of PCT, a protein associated with the body's response to a bacterial infection, as a biomarker to aid physicians in antibiotic management decisions for patients with LRTI or sepsis. It is expected to assist clinicians in identifying the appropriate use of antibiotics for these serious and sometimes life-threatening conditions, and help safely reduce the unnecessary use of antibiotics that may contribute to the rise in antibiotic-resistant infections.
Analysis Group led two study-level meta-analyses that figured prominently in the approval process for the expanded use of the test, working closely with the client, a clinical expert, and a communications vendor. The FDA approval was the result of a research effort undertaken in the second half of 2016, culminating in a presentation to the FDA's Microbiology Devices Panel. Dr. Kirson presented to the FDA on the statistical methods used, and served as the primary statistical responder to the panel's questions.