Developing Periprosthetic Joint Infection diagnostic assays
Luminex Licensed Technologies Partners represent a diversity of market segments, company sizes, and geographies. The versatility of xMAP® Technology has supported the launch of thousands of analytes formatted into commercially available kits and testing services.
Alexander Cameron, Diagnostics Global Product Manager at Zimmer Biomet, shares his journey with Luminex and how new diagnostic assays are improving joint replacement surgery outcomes for patients.
Can you tell us about your company and the products you offer?
I started with CD Diagnostics in 2012 as a Research Scientist. Zimmer Biomet acquired CD Diagnostics in August 2016. CD Diagnostics developed the Synovasure® Alpha Defensin Test, which is the first assay specifically designed and validated to aid in the diagnosis of Periprosthetic Joint Infection (PJI). The platform recently expanded to include the Synovasure® Microbial ID Test, which is based on Luminex xMAP Technology.
The Microbial ID Test includes a two-part Staphylococcus assay, a Candida assay and an Enterococcus faecalis assay. Based on the cross-reactivity of the assays, the panel covers approximately 65% of the organisms that are routinely cultured from infected joints.
CD Laboratories, a subsidiary of CD Diagnostics, provides Synovasure as a laboratory developed test for clinicians in the United States. Synovasure is also available in Europe and Asia in a lateral flow format. To date, more than 60,000 commercial assays have been run.
What are the benefits of the Synovasure® assay platform?
After receiving a prosthetic joint, patients often report symptoms of inflammation or pain. Approximately 1-2% of prosthetic joints will become infected, and it can be difficult to distinguish infection from other inflammatory diseases. Traditional diagnostic tools for PJI, such as culture of synovial fluid, are slow and have low sensitivity. In addition, traditional tests are influenced by systemic inflammatory diseases or antibiotic treatment. For example, antibiotic therapy can result in culture negative infections.
Accurate diagnosis of joint infection is critical for positive patient outcomes. A false negative diagnosis could leave an infection untreated and possibly lead to amputation or death, while a false positive could result in the unnecessary removal of the implanted joint.
The Synovasure® Alpha Defensin test was created to address this problem. In the U.S., physicians can use the service by sending samples to CD Laboratories.
Why did CD Diagnostics adopt xMAP Technology?
The R&D team wanted to develop an assay that would provide rapid and accurate results to orthopedic surgeons. They had commercial immunoassay development experience and knew that a multiplex assay would be the best solution.
While the Synovasure® Microbial ID Test was initially launched as a three organism panel, the R&D team is currently working to expand the panel. Part of the appeal of xMAP Technology is the ease in which new targets can be sequentially added once they are developed. The speed in which the assay transitioned from R&D to manufacturing to an on-market product was also a benefit.
Are you interested in developing, manufacturing, and commercializing a multiplexed assay on a platform that is efficient, flexible, and widely adopted? Contact Luminex Business Development to learn more.
xMAP is a trademark of Luminex Corporation. Synovasure is a trademark of CD Diagnostics.