OrthoDx
Summary: Designed by doctors, for doctors, Synvichor™ represents a new approach to one of the most challenging areas of orthopaedic diagnosis: distinguishing infection from inflammation.
Sydney, Australia, 17 October 2025: OrthoDx has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for Synvichor™, its in vitro diagnostic gene-expression assay designed to aid clinicians in differentiating infectious from non-infectious joint inflammation.
Synvichor analyses the body’s response to help identify whether acute joint pain is being driven by infection or non-infectious inflammation. The intended population includes individuals presenting with acute joint pain and clinical suspicion of joint infection or inflammation, including patients with a history of prosthetic joint replacement or previous native or prosthetic joint infection.
“Receiving Breakthrough Device Designation is an important milestone for OrthoDx and the development of Synvichor,” said Dr Antony Rapisarda, Founder and CEO of OrthoDx.
“Differentiating infection from inflammation can be extremely challenging for clinicians, particularly when time matters. We believe a host-response-based approach has the potential to provide valuable diagnostic information and greater confidence in clinical decision-making.”
“This designation gives us the opportunity to work more closely with the FDA as we continue the development and regulatory pathway for Synvichor in the United States.”
About the FDA’s Breakthrough Devices Program
The Program is designed for certain medical devices that have the potential to provide more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases or conditions.
Breakthrough Device Designation enables more frequent and interactive communication with the FDA and is intended to support efficient device development, assessment and regulatory review while maintaining the FDA’s standards for marketing authorisation.
About Synvichor™
Synvichor is an in vitro diagnostic gene-expression assay that analyses host response markers in synovial joint fluid.
Using proprietary biomarkers and established PCR technology, Synvichor is designed to interpret the body’s response to joint pain and aid clinicians in differentiating infectious from non-infectious joint inflammations.
By providing another source of diagnostic information at a critical point in the clinical pathway, Synvichor has the potential to support faster, more confident decision-making for patients with suspected joint infection.
Enquiries
Please contact us at info@orthodx.com.au
