ORLANDO, Fla., May 24, 2021 /PRNewswire/ — MicroGen Diagnostics, the industry leader in providing next-generation DNA sequencing (NGS) for clinical diagnostics, has introduced OrthoKEY, an innovative approach to address current clinical shortcomings in the diagnosis of orthopedic infections. OrthoKEY brings accuracy, sensitivity, timeliness, and affordability to PJI diagnostics and management for the clinic and operating room.
OrthoKEY is a new diagnostic tool that integrates synovial fluid analyses for biomarkers and white blood cell count with other parameters needed to make a diagnosis of periprosthetic joint infection — based on International Consensus Meeting diagnostic criteria. This evidence-based, algorithmic approach provides clinicians with the likelihood of infection with additional guidance on antimicrobial treatment with analysis of 17 antimicrobial resistance genes. OrthoKEY offers comprehensive, actionable diagnostic information in just 1-2 days to reduce the high costs and risks associated with treatment failure, followed by NGS identification of causative bacteria and fungi in 3-5 days.
OrthoKEY technologies have proven particularly effective in detecting and managing infections involving polymicrobial communities, viable but nonculturable (VBNC) bacteria, anaerobes, and atypical organisms — all of which can contribute to PJI even as they evade culture. MicroGenDX technology can identify the infective organism(s) in up to 90% of culture-negative infections, based on numerous studies.
«PJI is a devastating problem associated with joint replacement,» says Javad Parvizi, Orthopedic Surgeon and Director of Clinical Research at the Rothman Orthopedic Institute. «The five-year survivorship of patients with PJI is similar to common cancers at around 78%, yet we continue to struggle with the isolation of infective organisms in up to 40% of culture-negative cases. MicroGenDX’s OrthoKEY is an innovative approach to the diagnosis of PJI that provides clinically relevant information and removes ambiguity in the interpretation of data. OrthoKEY brings diagnosis of PJI into the 21st century.»
Two new products are available: OrthoKEY Clinic for aspiration samples, and OrthoKEY Surgery. OrthoKEY Surgery includes the innovative CaptiGen® flat swab for superior absorption of microbial DNA, biofilm retrieval and nucleic acid extraction.
Of particular significance, the NGS component of OrthoKEY may offer detection of otherwise untreated or undertreated persistent infections. A prospective multicenter study presented at the 2019 AAHKS meeting demonstrated that 68.6% of revision failures following two-stage exchange resulted from untreated or undertreated pathogens missed by culture but detected by NGS at the time of initial resection. For the most informed clinical decisions in PJI treatment, MicroGenDX recommends using OrthoKEY in combination with culture.
Founded in 2008, MicroGenDX has become the industry leader in rapid turnaround and affordability for comprehensive qPCR and next-generation sequencing (NGS) testing for clinical diagnostics. MicroGenDX has been the trusted research partner for the CDC, U.S. Army, Johnson & Johnson, Mayo Clinic, NASA and the FDA. MicroGenDX has published more than 35 clinical trials and is the most experienced molecular diagnostic laboratory with nearly 1.5 million samples processed.
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SOURCE MicroGen DX