“This is only the beginning of building our portfolios for CE-marked IVD products“ says CEO Meijie Tang. “pGOLD™ slides are the foundation for Nirmidas Multiplexed Assay Kits, like the Zika/Dengue and IgG Avidity Assay. They’re used in our 5-year supply and service agreement with a CLIA lab for the development of clinical testing.”
pGOLD™ slides are produced in a manufacturing lab in compliance with ISO13485 regulations. The production follows rigorous work instructions and quality control procedures. They ensure consistent performance and stability for use in research and development, and clinical tests in the near future.
Nirmidas has brought plasmonic gold technology (pGOLD™), an innovative signal amplifying platform, from scientific research to use in diagnostic assays (Research Use Only). pGOLD™ slides are a critical component in highly sensitive fluorescence enhanced multiplex assays.
Looking forward, Nirmidas is “working on building partnerships in the European Market and beyond. We see great potential for growth in diagnostic product development”. In addition, Nirmidas is seeking FDA clearance for its assay kits using the pGOLD™ slides.