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Luminex Lays Groundwork for Upcoming System, Assay Launches


NEW YORK (GenomeWeb) – Amid a sharpening focus on molecular diagnostics, Luminex officials this week said the firm remains on track to launch its Aries sample-to-answer system, along with its first assay, in the US before the end of the year.

In preparation for that, the company is taking an aggressive approach to establishing the system in the marketplace, applying more resources toward assay development and building out the sales team supporting the product line, Luminex President and CEO Nachum Shamir said on a conference call following the release of the firm's first quarter financial results.

Meanwhile, clinical testing of Luminex's NxTag Respiratory Pathogen Panel (RPP), which is based on a next-generation version of the firm's xTag universal tag system for multiplex nucleic acid assays, is on schedule, he said. That assay, which was launched earlier this year for research use only, is expected to receive US Food and Drug Administration approval around year-end and help the company regain customers who stopped using the test's predecessor.

Unveiled in 2013, Aries is designed as a lower-throughput alternative to the company's higher-throughput infectious disease panels for use by clinical labs. Luminex had originally planned to launch the system in the US this year, introducing assays for Clostridium difficile, herpes simplex virus (HSV) I and II, combined influenza A/influenza B/respiratory syncytial virus, norovirus, and group B Streptococcus.

In October, however, the company said that it had pushed back this timeline in order to run clinical trials for certain assays and to make system changes based on early-access customer feedback.

Last month, Luminex announced that it had completed clinical testing of the Aries HSV 1 and 2 assay, with submission of both the test and platform to the FDA expected by late summer. The firm said it has also begun a study on the C. difficile assay, with a planned FDA submission in the fourth quarter.

Both assays are expected to be available in the US and Europe around the end of the year.

And while Luminex expects to have the other Aries assays approved and launched in the US by mid-2016, Shamir said that the company is "trying to accelerate this timeline" in order to get a foothold in the market as soon as possible.

In addition to shifting additional resources onto assay development, Luminex is also planning on adding seven to 10 new employees to its US molecular diagnostics sales force, which currently has about 17 dedicated staffers, he said.

"We believe … that will give us a good coverage going into [2016] and almost until the end of [2016]," Shamir noted, adding that Luminex is still evaluating whether it needs to expand its sales team in Europe and the Far East.

Also expected to benefit from the company's ramp up of its molecular diagnostics sales efforts is NxTag RPP, which is designed to simultaneously detect 22 respiratory pathogens in a single closed tube and runs on the company's existing bead array systems.

With minimal hands-on time and no upstream reagent preparation, NxTag RPP is being positioned as a replacement for the xTag Respiratory Virus Panel introduced in 2008.

During the conference call, Luminex CFO Harriss Currie said that in addition to current xTag RVP users, NxTag RPP is expected to attract customers that moved away from xTag RVP because of its complexity.

"We believe there is a significant opportunity to recapture customers that left because of … other products that are easy to use," even though they may lack the throughput of Luminex's offering, he said, adding that the number of steps required with xTag RVP has "historically … been one of the highest-level complaint issues of the product."

"Our advantage remains the throughput that our product and our technology provides," he said. With the simplified workflow of NxTag RPP, "we are excited about the opportunities that product provides."