CD Diagnostics Gets FDA Nod For Diagnostic Test To Detect Prosthetic Joint Infections

CD Diagnostics has secured marketing approval from the US Food and Drug Administration (FDA) for its Synovasure Lateral Flow Test Kit to detect prosthetic joint infections.

Synovasure Lateral Flow Test Kit will help detect periprosthetic joint infection (infection around a joint replacement) in the synovial (lubricant) fluid of patients being assessed for revision surgery, which is a surgery carried out to replace or compensate for a failed implant.

Via de novo premarket review pathway, the FDA assessed data for the Synovasure Lateral Flow Test Kit.

The surgeons will remove damaged cartilage and bone from the surface of the joint and replaces it with a prosthetic joint implant, during a joint replacement surgery.

Synovasure Lateral Flow Test Kit will identify proteins called human alpha defensins in the synovial fluid of patients with a total joint replacement in around 10 minutes.

The kit will help determine whether there is an infection present in synovial fluid, and is not intended to detect a specific type of infection.

Results from the test can also be used along with other clinical and diagnostic findings to assist in a patient’s diagnosis of prosthetic joint infection.

The FDA assessed data from a clinical study, which analyzed 305 prospective synovial fluid samples collected from individuals with a total knee or hip joint replacement who were being evaluated for revision surgery.

According to FDA, the study demonstrated that 89.5% of subjects with an infection diagnosis based on standard of care criteria were also identified as positive for alpha defensin by the Synovasure Lateral Flow Test Kit.

The FDA’s Center for Devices and Radiological Health’s in vitro diagnostics and radiological health office director Dr Tim Stenzel said: “Prior to today’s authorization, there were no FDA-authorized diagnostic tests specifically designed to help health care professionals determine whether the inflammation around a prosthetic joint was due to an infection or another cause.

“With this test, health care professionals now have an additional option available to aid their clinical assessment as to whether the patient has an infection and requires revision surgery.” – Compelo