Luminex Initiates Clinical Trials for VERIGENE® II Gastrointestinal Assay
Published: Jun 13, 2018
Luminex Corporation (NASDAQ: LMNX) today 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 & Medicaid Services' Protecting Access to Medicare Act (PAMA) and Palmetto reimbursement cuts.
The clinical study is being conducted at approximately twelve sites in the U.S. 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. For more information, visit https://www.luminexcorp.com/clinical/instruments/the-verigene-system/ or http://info.luminexcorp.com/request-information.
About Luminex Corporation
At Luminex, our mission is to empower labs to obtain reliable, timely, and actionable answers, ultimately advancing health. We offer a wide range of solutions applicable in diverse markets including clinical diagnostics, pharmaceutical drug discovery, biomedical research, genomic and proteomic research, biodefense research, and food safety. We accelerate reliable answers while simplifying complexity and deliver certainty with a seamless experience. To learn more about Luminex, please visit us at www.luminexcorp.com.
Statements made in this release that express Luminex's or management's intentions, plans, beliefs, expectations or predictions of future events are forward-looking statements. Forward-looking statements in this release include statements regarding the available market and customer acceptance for the VERIGENE® II System, future revenue growth anticipated for our VERIGENE ® products, and the development, clinical trial and other testing and regulatory approval progress of our pipeline products, including VERIGENE ® II related assays. The words "believe", "expect", "intend", "anticipates", "confident", "will", "could", "should", and similar expressions are intended to further identify such forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. It is important to note that the Company's actual results or performance could differ materially from those anticipated in such forward-looking statements. Factors that could cause Luminex's actual results or performance to differ materially include risks and uncertainties relating to, among others, our ability to launch products on time, the timing of regulatory approvals, the outcome of clinical trials as well as the risks discussed under the heading "Risk Factors" in Luminex's Reports on Forms 10-K and 10-Q, as filed with the Securities and Exchange Commission. The forward-looking statements contained herein represent the judgment of Luminex as of the date of this press release, and Luminex expressly disclaims any intent, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in Luminex's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
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SOURCE Luminex Corporation
Company Codes: NASDAQ-NMS:LMNX