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Verigene II, New Assay Launches Anticipated to Revivify Luminex Revenues in 2020

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NEW YORK – Booking less business with Laboratory Corporation of America has curbed Luminex growth in recent quarters, but the Austin, Texas-based company believes product launches this year will lead to a revivification of its business.

The firm announced full-year 2019 revenues on Monday of $334.6 million spurred in part by 12 percent year-over year-growth in its fourth quarter. However, Luminex has more ambitious revenue targets in mind, as its CEO Nachum Shamir said that the firm anticipates $500 million per year in revenues in "the next few years."

On a conference call to discuss its financial results Monday, Shamir and other Luminex executives described new products in the pipeline expected to boost future revenue growth, including the Verigene II multiplex system, which has been in development for several years. In Q4, Luminex applied for marketing clearance to the US Food and Drug Administration for Verigene II and the first assay for the system, a gastrointestinal panel, and it expects both to launch in mid-2020. Next week, it expects to submit a second Verigene II panel, for respiratory conditions, to the agency.

Shamir said that as the firm moves through 2020 with the launch of the Verigene II product, it estimates "that sample-to-answer revenues will be up approximately 25 percent for the year."

"Many improvements that come with the Verigene II system should make for a compelling offering over both the current system and competitive products," he said.

Apart from being full automated, the system has room temperature storage and a reduced footprint over its predecessor, while achieving equivalent throughput, he said. Luminex is designing the new system's assays to enable labs to pay only for what they need, he said, features that "give us confidence that our current growth trajectory in sample-to-answer solution will continue to be strong."

The introduction of Verigene II and its assays could provide a boost to Luminex's MDx portfolio, whose revenues remained unchanged year over year at $38.8 million for Q4 2019, and were down 16 percent year over year for full-year 2019.

Throughout 2019, the company blamed the discontinuation of LabCorp revenues as a headwind to year-over-year comparisons, and for the full year, the lost LabCorp revenues had an impact of about $32 million, the company said.

Q1 2020 revenues are expected to be between $82 million and $84 million, which accounts for a reduction from prior-year booked LabCorp revenue by approximately $4.5 million.

Harriss Currie, the firm's CFO, said on the conference call that the firm's first quarter will be the last that LabCorp's women's health will drag on Luminex's revenues, though "we will continue to be affected by [LabCorp's cystic fibrosis-related] declines of approximately $2 million per quarter until the end of the year."

Declines in cystic fibrosis product demand "are purely the result of the timing of contractual commitments, but we anticipate LabCorp CF revenues will increase in 2021 compared to 2020," he added.

Another product that the firm anticipates launching in the middle of this year stems from a deal completed at the beginning of last year — the purchase of MilliporeSigma's flow cytometry portfolio for $75 million.

With the flow cytometry business came MilliporeSigma's Guava portfolio of products, which leverages microcapillary technology for cell-based analysis.

The Guava Next-Gen System is mainly a software update to an existing Guava system, expected to strengthen the firm's position as a leader in the benchtop flow cytometry space. "We think that [the new product] will help us further establish ourselves as a player in the mid-level flow cytometry business," Currie said.

Luminex also anticipates rolling out the next generation of its xMap system, formerly named Sensiplex, under a new name, xMap Intelliflex. The xMap system combines advanced fluidics, optics, and digital signal processing with microsphere technology to deliver multiplexed assay capabilities.

During the past 20 years, Luminex has placed about 17,000 xMap systems. The new xMap Intelliflex "provides a modern enhancement" to the xMap platform, Shamir said, adding initial marketing and sales efforts for the system will be focused on the proteomics research space.

Luminex has also completed product development targeted at the novel coronavirus, 2019-nCoV, that so far has infected about 45,000 individuals, the overwhelming majority in China. Last week, the company applied to the National Medical Products Administration for emergency use authorization of its NxTag Respiratory Pathogen Panel (RPP). Further, a few weeks ago, it completed "a large clinical trial in China" associated with the RPP test and has plans to apply soon for marketing clearance with the NMPA, Shamir said. 

The FDA-cleared NxTag RPP test has 20 targets of which four are associated with coronaviruses but not the 2019-nCoV coronavirus first identified in Wuhan, China. However, the product can help rule out respiratory infections not associated with the new coronavirus, Shamir said.

He added that the Chinese Center for Disease Control and Prevention has requested that Luminex "create a small panel" based on the NxTag chemistry. The firm has developed a multiplex panel to detect 2019-nCoV, as well as the severe acute respiratory syndrome (SARS) virus and the Middle East respiratory syndrome (MERS) virus. It expects to ship the panel to the China CDC for testing within a few weeks, Shamir said.

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