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Luminex Delays Commercial Launch of Aries MDx System to Address Early-Access Feedback


NEW YORK (GenomeWeb) — Luminex executives this week informed investors that the company has pushed back the commercialization timeline of Aries, the sample-to-answer molecular diagnostics system it has been developing for lower-throughput clinical laboratories as a complement to its higher-throughput infectious disease panels.

Specifically, company officials noted that the platform, which was targeted for a European launch later this year and a US launch in early 2015, will now undergo clinical trials in the first half of next year in anticipation of a mid-summer 2015 European CE mark and late 2015 US Food and Drug Administration approval.

Luminex executives discussed Aries, among other items, during a conference call yesterday following release of the company's third quarter 2014 earnings. For the three months ended Sept. 30, the Austin, Texas-based molecular diagnostics firm tallied $56.7 million in revenues, compared to $50.8 million in the year-ago period. This included a 1 percent uptick in system sales and a 37 percent increase in assay revenue. Notably, the company's consumables sales deteriorated 6 percent year over year, which the company chalked up to seasonal "lumpiness" related to bulk consumable orders from customers.

A full recap of Luminex's earnings can be found here.

Luminex officially unveiled the Aries system last November at the Association for Molecular Pathology annual meeting, along with its plans to commercially launch assays for Clostridium difficile, herpes simplex virus I and II, and combined influenza A/influenza B/respiratory syncytial virus. Since that time, the company has also revealed plans to launch assays for norovirus and group B Streptococcus on the platform.

In addition to running the aforementioned commercial assays, the system will enable users to create laboratory-developed tests using their own analyte-specific reagents or those sold by Luminex. Aries combines real-time PCR chemistry Luminex acquired in 2012 along with EraGen Biosciences with the sample-to-answer molecular testing instrument it acquired along with startup GenturaDx that same year, and the company has been positioning the platform as a higher-throughput, target-specific option for small- to mid-sized labs.

This complements the company's existing respiratory and gastrointestinal pathogen panels that use the relatively lower throughput but more highly multiplexed xTag and next-generation NxTag assays and thus are ideal for larger-volume labs — a key point underscored by CFO Harriss Currie during yesterday's call.

"The ability to offer both targeted testing on an Aries system along with syndromic panels through our xTag and NxTag product lines will provide Luminex with a unique strategic advantage, positioning us as the only company in the marketplace offering laboratories a complete testing solution," Currie said.

Currie also noted that the market for the Aries launch menu alone represents "a major revenue opportunity that we believe is growing at strong double-digit rates." As such, the company has been pouring R&D dollars into the platform — and has been placing it with early-access users to gather and incorporate feedback.

"Today, the bulk of our R&D investment is directed at the Aries platform, which is our largest opportunity to date," Currie said.

Given this opportunity, however, Luminex has decided to take a step back to make sure it gets things rights, Currie and new CEO Nachum Shamir noted during the call.

"Given the significance of this initiative to the company, we began a comprehensive review of the program six months ago, considering a number of factors, including product design, customer requirements, and launch schedule," Currie said, adding that Luminex decided not to update investors on this review during the company's second quarter earnings call "given that we were in the middle of this important strategic review."

Shamir, who recently replaced longtime Luminex CEO Patrick Balthrop, said during the call that the company now anticipates beginning clinical trials near the end of Q1 2015, followed by a 510(k) submission to FDA in the late summer — coinciding with the company's planned launch of the platform as an RUO product in the US.

"Therefore, we are targeting IVD clearance in the US of the system and [the herpes simplex virus] assay during the fourth quarter of 2015, pending the review of the submission by the FDA," Shamir said. "Shortly thereafter, we expect to receive clearance for the remaining launch assays with all five assays cleared by the second quarter of 2016. We are confident in our ability to execute the timeline announced today and I look forward to providing an update on future calls."

Further justifying the commercialization delay, Currie noted during the call that the company has encountered "challenges" and "opportunities" over the past six months that have helped "hone our understanding of customer requirements to ensure that the developed product most appropriately met the needs of the customers, and we had the opportunity to tweak it a little bit and to add some of those features."

As a result, Currie added, "the final product … will be even better-accepted in the marketplace than it would have been [had we] not been able to make those adjustments. We really get only one chance to get this right with the system like this. And so, it's very important that we do it right the first time so we can get a great start out of the gate with a system … that we believe is a game changer."

Neither Currie nor Shamir disclosed specifics about the types of changes Luminex is making to the Aries system in response to customer feedback.