Luminex Corporation announced the company recently began clinical studies for the Gastrointestinal (GI) Assay on the VERIGENE II System, its new sample to answer benchtop molecular diagnostic system in development. The VERIGENE System enables clinicians to rapidly identify the pathogens responsible for some of the most complex, costly, and deadly human infectious diseases. The system offers automated, cost-effective multiplex capabilities that accurately detect infectious pathogens and drug resistance markers, without relying on time-consuming culture methods. The VERIGENE II System contains the same core nanoparticle chemistry as the current VERIGENE System, while consolidating four individual consumables into a single cartridge within a closed system for a much simpler workflow.
The new fully automated system will support ambient temperature storage and up to six modules for random access testing at any given time. “The VERIGENE II System is an excellent example of our commitment to innovation and to simplifying complexity in diagnostic testing,” said Homi Shamir, President and Chief Executive Officer of Luminex. “The VERIGENE II System is extremely easy to use, reduces hands-on time, and offers users a great deal of flexibility. We anticipate this GI panel study will be the first of many IVD assay clinical studies to be conducted on this next-generation platform. We are also on track to begin clinical trials on our VERIGENE II Respiratory Assay later this year, followed by panels for blood culture and meningitis.” The VERIGENE II GI Assay is an automated test for the detection and identification of enteric bacteria, viruses, parasites, and toxins in stool samples.
The panel has been built to include the targets identified in the recently updated Infectious Diseases Society of America (IDSA) guidelines. With less than two minutes of hands-on time and fast overall turnaround time, the GI Assay is designed to provide rapid results on a wide breadth of clinically relevant analytes for comprehensive coverage of idiopathic GI disease. The GI panel will also feature Flex testing – a unique feature of the VERIGENE System – enabling clinicians to test and pay for only the relevant pathogens they are interested in for specific patients and geographical regions. Additional results not initially reported after test completion can be reflexed instantly at an extra cost without running an additional test. Luminex’s Flex Pricing approach was designed, in part, to help customers manage through pricing pressures, such as those resulting from the Centers for Medicare and Medicaid Services’ Protecting Access to Medicare Act (PAMA) and Palmetto reimbursement cuts.
The clinical study is being conducted at approximately twelve sites in the US Following a successful trial, the company expects to submit the GI Assay, the first IVD test for use on the VERIGENE II System, for CE marking and FDA clearance next year. The VERIGENE II is part of Luminex’s growing portfolio of sample to answer molecular diagnostic solutions, which also includes the ARIES Systems. The Luminex portfolio for gastrointestinal diagnostics includes the ARIES C. difficile Assay, the VERIGENE Enteric Pathogens Test (EP), and the xTAG Gastrointestinal Pathogen Panel (GPP), which offers the ability to mask targets and create custom panels for patient populations. The VERIGENE II System is under development and not currently FDA cleared or CE Marked for IVD use. – Medical Buyer Bureau