Zimmer Biomet subsidiary CD Diagnostics received de novo marketing authorization for the Synovasure Lateral Flow Test Kit, a first-of-its-kind in vitro diagnostic designed to identify markers of periprosthetic joint infection. These infections, which occur in and around joint replacements (including knees and hips), can be painful and dangerous. They are a common cause of joint hardware failure and thus often lead to revision surgery.
The test detects proteins in synovial fluid called human alpha defensins, which are associated with joint infection, in approximately 10 minutes. Alternative diagnostics, including imaging and laboratory assessments of the fluid, can take days to complete.
Zimmer Biomet acquired CD Diagnostics in 2016, after first partnering with the diagnostics company in 2012.
