US FDA grants approval for Luminex’s NxTAG respiratory pathogen panel

20 December 2015 (Last Updated November 22nd, 2018 11:20)

Luminex has secured approval from the US Food and Drug Administration (FDA) for its NxTAG respiratory pathogen panel that is capable of detecting simultaneously 20 clinically relevant viral and bacterial respiratory pathogens.

Luminex

Luminex has secured approval from the US Food and Drug Administration (FDA) for its NxTAG respiratory pathogen panel that is capable of detecting simultaneously 20 clinically relevant viral and bacterial respiratory pathogens.

The closed-tube respiratory pathogen panel detects atypical bacteria such as Chlamydophila pneumoniae and Mycoplasma pneumonia.

Its tube-strip design enables laboratories to manage variable sample demand by processing a single sample or up to 96 samples per run, without wasting consumables or reagents.

The NxTAG respiratory pathogen panel employs Synct Software, which enables it to integrate easily into any laboratory by providing data analysis and reporting.

Using this panel, laboratories can accommodate changes in throughput to respond to seasonal changes in demand, such as flu season.

Luminex president and CEO Homi Shamir said: "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 NxTAG respiratory viral panel.

"The NxTAG respiratory pathogen panel offers clear advantages when compared with other respiratory panels on the market."

"With advantages such as minimal hands-on time, fast time to results, and target masking for panel customisation, the NxTAG respiratory pathogen panel offers clear advantages when compared with other respiratory panels on the market."

The panel does not require any upstream reagent preparation and it detects pathogens in less time. It allows direct addition of extracted samples to pre-plated and lyophilised reagents.

The tubes are then sealed to undergo closed-tube amplification and subsequent detection using the Luminex Magpix instrument.

Earlier in October this year, the company received CE-IVD mark approval for the respiratory pathogen panel.


Image: NxTAG respiratory pathogen panel detects 20 clinically relevant viral and bacterial respiratory pathogens. Photo: courtesy of Luminex Corporation.