Luminex Corporation Submits VERIGENE® II Respiratory Flex Assay for FDA Clearance

Luminex reports this assay, along with the Gastrointestinal (GI) Flex Assay, both run on Luminex’s new VERIGENE II system. The GI Flex Assay is an automated test for the detection and identification of enteric bacteria, viruses, parasites, and toxins in stool samples. Both are now under review with the FDA, and Luminex anticipates launching the new VERIGENE II assays mid-year.

“We are delivering on our strategy and our promise to expand the menu of clinically relevant, high-value tests that accelerate and simplify diagnostic testing,” said Homi Shamir, President, and CEO of Luminex. “We’re also demonstrating once again the cost-effectiveness of rapid testing on a Luminex platform. The flexibility of the automated VERIGENE II System uniquely allows clinical laboratories to select, test and pay for only the targets ordered for each patient. This is a game-changer for many laboratories.”

The VERIGENE II System is a benchtop molecular diagnostic system that uses advanced automation and specialized chemistry to enable rapid, sample-to-result detection. The RSP Flex Test is performed on this system utilizing reverse transcription, polymerase chain reaction, and array hybridization to detect specific respiratory viral and bacterial pathogen nucleic-acid gene sequences.

“By expanding the foundational assays on our next-generation VERIGENE system to a wider variety of common viruses and bacteria, we are helping laboratories deliver fast, accurate results and are streamlining the process of sample testing,” said Shamir.

When targeted therapies depend on clinical test results, testing of nasopharyngeal samples for specific pathogens is highly useful, especially given that respiratory tract infections (RTIs) are among the three most common acute illnesses evaluated in outpatient care.1 Children are particularly vulnerable to RTIs, with an average of six per year.2 If these illnesses are not diagnosed accurately or quickly enough, they can lead to more serious illness and, in severe cases, to increased childhood mortality. The VERIGENE II RSP Flex Assay delivers a critical test that is designed to address this widespread and costly challenge.

Hot this week

Recor Medical Reports: CMS Grants Distinct TPT Device Code and Category to Recor Medical for Ultrasound Renal Denervation

The approval of TPT offers incremental reimbursement payments for outpatient procedures performed with ultrasound renal denervation for Medicare fee-for-service beneficiaries. It becomes effective January 1, 2025, and is expected to remain effective for up to three years notes Recor Medical.

Jupiter Endovascular Reports | 1st U.S. Patient Treated with Jupiter Shape-shifting Thrombectomy Device

“Navigation challenges during endovascular procedures are often underappreciated and have led to under-adoption of life-saving procedures, such as pulmonary embolectomy. We have purpose-built our Endoportal Control technology to solve these issues and make important endovascular procedures accessible to more clinicians and their patients who can benefit from them,” said Carl J. St. Bernard, Jupiter Endovascular CEO. “This first case in the U.S. could not have gone better, and appears to validate the safety and performance we are seeing in our currently-enrolling European SPIRARE I study.”

Avery Dennison Medical Introduces Ipdated SilFoam Lite: Sustainability, MDR Certification & Performance Improvements

The newly enhanced SilFoam Lite delivers superior efficiency and reliability, bringing improved fluid handling capabilities and improved tack. These improvements make the product ideal for customers seeking quality, high-performance solutions in wound care notes Avery Dennison Medical.

Voluntary Recall Notifying Medtronic Insulin Pump Users of Potential Risks of Shortened Pump Battery Life

Medtronic plc voluntarily issued a field action starting on July 31, 2024, notifying global customers of its MiniMed™ 600 series or 700 series insulin pumps to follow their pump's built-in alerts and alarms for battery status and to contact Medtronic if they observe changes in the battery life of their pump

Medtronic Expands AiBLE Spine Surgery Ecosystem with New Technologies and Siemens Healthineers Partnership

New advancements in the AiBLE Spine Surgery ecosystem build upon the company's commitment to procedural innovation and execution