Luminex Snags FDA Approval for NxTAG Respiratory Pathogen Panel

December 18, 2015 |

5 min read

Luminex Receives FDA Clearance for NxTAG Respiratory Pathogen Panel

AUSTIN, Texas, Dec. 18, 2015 /PRNewswire/ -- Luminex Corporation (NASDAQ: LMNX) today announced that it has received FDA clearance for its NxTAG® Respiratory Pathogen Panel that detects 20 clinically relevant viral and bacterial respiratory pathogens, including the atypical bacteria Chlamydophila pneumoniae and Mycoplasma pneumonia. The panel is the only respiratory assay that enables laboratories to easily and simultaneously detect 20 respiratory pathogens in a single closed tube system in a format that scales to accommodate changes in throughput needed to respond to seasonal changes in demand, especially during flu season. FDA clearance, which was received less than 90 days from submission, follows the CE Mark received for the panel in October.

NxTAG Respiratory Pathogen Panel is an assay that detects relevant viral and bacterial respiratory pathogens, including the atypical bacteria Chlamydophila pneumoniae and Mycoplasma pneumonia.

“We are excited to bring this next generation respiratory pathogen panel to market,” said Homi Shamir, President and CEO of Luminex. “The NxTAG Respiratory Pathogen Panel incorporates extensive user feedback, delivers expanded panel coverage, features a simple closed tube workflow, and is combined with the throughput and quality of results established by the xTAG® Respiratory Viral Panel. With advantages such as minimal hands-on time, fast time to results, and target masking for panel customization, the NxTAG Respiratory Pathogen Panel offers clear advantages when compared with other respiratory panels on the market. In conclusion, 2015 has been a busy year with multiple product development milestones achieved, of which the FDA clearance of NxTAG Respiratory Pathogen Panel follows closely the FDA clearance of the ARIES sample to answer molecular system. These new products should position Luminex well for accelerating growth.”

The NxTAG Respiratory Pathogen Panel requires only minutes of hands-on time, with no upstream reagent preparation. A simplified workflow allows extracted samples to be added directly to pre-plated, lyophilized reagents. The tubes are then sealed and ready for closed-tube amplification and subsequent detection using the Luminex MAGPIX® instrument. The innovative tube-strip design offers laboratories the flexibility to manage variable sample demand by processing a single sample or up to as many as 96 samples per run, without wasting consumables or reagents. Total turnaround time is only about three hours for 96 samples, excluding extraction.

In addition, the accompanying SYNCT Software provides a comprehensive approach to data analysis and reporting, and enables the NxTAG Respiratory Pathogen Panel to integrate easily into any laboratory. Any of a number of targets can be selected by laboratories to customize their testing panel.

To learn more or request a demo, visit: www.luminexcorp.com/nxtag

Why Test for Respiratory Pathogens?

Many commonly encountered respiratory pathogens (viral and bacterial) have similar clinical presentation, making diagnosis based on symptoms alone very difficult. Influenza viruses commonly cause respiratory illness, but many other pathogens may cause significant impact on patient health as well. Respiratory syncytial virus (RSV), as one example, is the most common cause of severe respiratory illness in young children, as well as a leading cause of death from respiratory illness in those aged 65 years and older.¹

A clinician needs to accurately detect the respiratory pathogen causing illness in the patient in order to effectively prescribe treatment and control the spread of infection. Laboratories need respiratory assays that can rapidly and efficiently detect these relevant pathogens with minimal hands-on time and no post-PCR handling to meet laboratory, physician, and patient needs.

Reference

1. Seasonal Influenza & Other Respiratory Viruses. Centers for Disease Control (Internet). Cited 2015 March. Available from: http://www.cdc.gov/flu/about/qa/other.htm.

About Luminex Corporation
Luminex is committed to applying its passion for innovation toward creating breakthrough solutions to improve health and advance science. The company is transforming global healthcare and life-science research through the development, manufacturing and marketing of proprietary instruments and assays utilizing xMAP® open-architecture multi-analyte platform, MultiCode® real-time polymerase chain reaction (PCR), and multiplex PCR-based technologies, that deliver cost-effective rapid results to clinicians and researchers. Luminex’s technology is commercially available worldwide and in use in leading clinical laboratories, as well as major pharmaceutical, diagnostic, biotechnology and life-science companies. Luminex is meeting the needs of customers in markets as diverse as clinical diagnostics, pharmaceutical drug discovery, biomedical research including genomic and proteomic research, personalized medicine, biodefense research and food safety. For further information on Luminex Corporation and the latest advances in multiplexing using award winning technology, please visit http://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 development and testing progress of our pipeline products, and the regulatory approvals thereof. 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.

Contacts
Luminex Investor Contact
Harriss Currie
Sr. Vice President of Finance and CFO
512.219.8020
hcurrie@luminexcorp.com

Luminex Media Contact
Christine Valle
Sr. Manager, Global Marketing
512.219.8020
cvalle@luminexcorp.com