In 2012 Zimmer Biomet Holdings, Inc. began partnering with Delaware-based CD Diagnostics to market the Synovasure Periprosthetic Joint Infection (PJI) test. This was the first test specifically designed and validated for the diagnosis of PJI.
On August 15, 2016, Zimmer Biomet announced it was acquiring CD Diagnostics. Financial terms were not disclosed.
The Musculoskeletal Infection Society (MSIS) published the first set of criteria defining the diagnosis of PJI in 2011.
Carl Deirmengian, M.D., the scientific founder of CD Diagnostics, said he formed the company in that year, “to solve the frustrating problem of diagnosing PJI and the complications associated with misdiagnosis, including the pain and incremental costs-of-care following joint replacement surgery.”
The company focused on analyzing biomarker profiles for various clinical conditions in synovial fluid (a viscous fluid that reduces friction between articular cartilage), and creating diagnostic assays to help physicians make informed decisions. More than 40, 000 samples have been evaluated at CD Diagnostics’ laboratories resulting in more than 15 peer-reviewed publications.
According to an “Editor’s Spotlight” by Montri Wongworawat, M.D. in an April 2014 article in Clinical Orthopaedics and Related Research, “By comparing synovial fluid biomarker assays to the MSIS PJI definition in patients with revision arthroplasty, the lab identified several markers with excellent diagnostic performance. The beauty of this study lies in the inclusion of patients with inflammatory diseases as well as individuals taking antibiotics; while systemic inflammation and antibiotic use often confound the clinical picture, synovial fluid biomarkers show diagnostic accuracy even in these complex situations.”
“The Synovasure test is having an impact on patient outcomes because with this new test device, we are able to detect the periprosthetic infection with high accuracy. This is the first time we are able to tell the patient if they have an infection within hours of testing, ” said Prof. Dr. Thorsten Gehrke, Helios Indo-Klinik, Hamburg, Germany.
CD Diagnostics
CD Diagnostics holds patents on biomarker diagnostics and currently offers seven unique tests.
Synovasure PJI was the company’s first product with tests now available in the U.S., and CE marked in both ELISA plate and lateral flow formats in Europe. The company provides its clinical testing services through its subsidiary CLIA laboratory, Citrano Medical Laboratories. Citrano Medical Laboratories is a key component in the company’s commercialization strategy, as it allows CD Diagnostics to rapidly commercialize products with well-established automated systems for result reporting and billing.
“Research on the Synovasure infection diagnostic test has led to breakthroughs in the areas of sepsis and bacterial meningitis. These diseases are similar infections, but found in different matrices; synovial fluid, blood, and cerebrospinal fluid, respectively. CD Diagnostics’ product developments include direct bacterial antigen detection as well as biomarker detection, ” according to the CD Diagnostic website.
“As a leader and visionary in musculoskeletal healthcare, Zimmer Biomet is the ideal partner to leverage our expertise in biomarker detection and immunoassay development, and to elevate the value of diagnostics in the treatment of musculoskeletal conditions, ” said Deirmengian.
“Value-Based” Tool
Dan Williamson, Group President, Joint Reconstruction for Zimmer Biomet, said, “As value-based healthcare replaces fee-for-service models, there will be a growing need for diagnostics that can either prevent or minimize costly complications, or personalize the course of treatment to speed up recovery time and optimize the patient experience and, ultimately, the patient’s outcome.”
