Staphylococcus.MDx MRSA+ Diagnostic Test – Identifies and differentiates resistant and non-resistant strains of Staphylococcus including MRSA and Coagulase Negative Staphylococcus (CNS).
Disease Background: Staphylococcus infections are the most common hospital acquired or associated infections (HAI). While most of the focus over the past few years has been on MRSA, in terms of incidence and total cost, strains of Staphylococcus other than MRSA are a much more common problem. Due to the increasing use of implantable biomaterials and medical devices, infections are frequently caused by Coagulase Negative Staphylococcus (CNS). This is a type of Staphylococcus which is often resistant to multiple antibiotics and has a particular affinity for these devices. Rapid identification and differentiation of these resistant bacteria is key to optimizing treatment decisions that significantly impact patient outcomes and cost of care. Given that resistant coagulase negative Staphylococcus is a frequent pathogen in surgical site infections, wounds, orthopedic and cardiac device infections and blood stream infections (among others), it is critical to be able to rapidly identify and determine antibiotic resistance to provide for early effective treatment. Current molecular tests for MRSA all ignore coagulase negative Staphylococcus making these test results much less useful in treating patients than they could be.
Staphylococcus Test: The Staphylococcus diagnostic test identifies and differentiates resistant and non-resistant strains of Staphylococcus aureus and coagulase negative Staphylococcus. The test uses three separate proprietary targets and a proprietary methodology to determine which type(s) of staphylococcus are present and which carry the gene that causes antibiotic resistance in these bacteria. This is also effective in infected specimens where there are multiple types of Staphylococcus. The test will provide much broader clinically actionable results than current molecular tests in 60 minutes improving early intervention, resulting in more effective treatment of these infections and lower treatment costs.
The intellectual property (IP) used in the diagnostic assay is exclusive to GMD and is concurrently being developed for use in screening surgical patients to determine if they are colonized with Staphylococcus. The information from screening is used to determine the appropriate antibiotic prophylaxis regimen required to prevent post surgical infections based on the specific Staphylococcus strains that the individual patient is carrying.