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Reimbursement Uncertainty, Nanosphere Success Give Luminex Pause in Commercial Plan for Next Instrument

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NEW YORK (GenomeWeb) – Luminex reported strong quarterly financial results on Monday, but said it is delaying until further notice the start of clinical trials for Verigene 2, an automated multiplex instrument that the firm is developing for infectious disease testing.

Luminex acquired Verigene 2 when it acquired Nanosphere in 2016. When it did, the firm halted development of Aries 2, its own higher plex instrument, in favor of developing the Verigene 2 product, also called Atlas.

Several factors led to the delay in developing Verigene 2, including issues around cassette failure rates and test reimbursement uncertainty, Luminex CEO Homi Shamir said during a conference call with analysts on Monday while discussing financial results.

Analysts were caught off guard by the announcement to halt Verigene 2 clinical trials.

Chief among the reason for the delay is the success of Verigene 1 in the marketplace, which has exceeded the firm's expectations, Shamir said. The system — cleared for sale in the US, Europe, and elsewhere — is used with gram-positive and gram-negative blood culture tests; C. difficile, and enteric assays; and respiratory pathogen flex tests that provide a broad respiratory panel.

To date, Verigene 1's accumulated sales exceed $100 million, and the firm is receiving positive feedback from customers who like the system's flexibility, Shamir said.

As far back as 2007, Nanosphere received US Food and Drug Administration clearance for the Verigene platform and a warfarin metabolism nucleic-acid test. However, sales did not begin to accelerate until Luminex purchased the company.

Shamir said he believes that this is being driven by the stability of Luminex and the speed with which it integrated Nanosphere. Additionally, he said that Luminex continues to invest in Verigene, and that it has expanded its manufacturing capabilities to accommodate growth. There are "many things that Nanosphere could not afford to do because of financial stress, but we could afford it," he said. 

Shamir noted that apart from the boost given to Luminex's growth by its current Verigene product, the firm's decision to halt clinical trials for the new system was influenced by uncertainty created by a non-coverage draft recommendation by Medicare contractor Palmetto GBA. The recommendation could impact reimbursements for certain multiplexed panels used in outpatient testing, according to industry analysts.

Shamir noted that Palmetto, which often provides a path that other Medicare contractors follow, "has created some uncertainty about what will happen in pricing and reimbursement, and how to approach it." He said that clinical trials at 12 sites to validate the instrument with an enteric assay was expected to cost $5 million.

But he also said that he believed that the Palmetto recommendation would benefit Luminex because of its test portfolio flexibility, including lower- and higher- plexed tests. "The overall solution is helping us to be extremely competitive in the market," Shamir said.

Brian Weinstein, an analyst with William Blair, wrote that he suspects that between 20 and 30 percent of testing may be at risk if all payors issued non-coverage decisions that impacted testing of outpatient samples, which he believes is unlikely. While Luminex's "flexible panel approach in respiratory testing may be beneficial, our understanding is the Palmetto recommendation would affect all outpatient respiratory panels, and, as a result, would be problematic for Luminex in the same way it is for other companies who offer broader panels," he said.

Issues related to reimbursement for higher plex tests are likely to remain unresolved for a while. Several professional organizations have communicated with Palmetto arguing against a cut in outpatient reimbursement and we should get a final statement on this in the coming months, Weinstein said.

And while Luminex takes a wait-and-see approach to the uncertainty created by the Palmetto draft recommendation, it is simultaneously considering altering its earlier strategic objective to first obtain FDA clearance for just one assay, the enteric test, on the Verigene 2 platform.

It might be "worthwhile to wait and launch it with two or three assays together," Shamir said, adding that with one assay on a platform, a customer does not have the opportunity to "use the platform to its full extent."

Luminex also has some internal development issues related to Verigene 2, he added. "Our target for the failure rate of the [Verigene 2] cassette is less than 5 percent," Shamir said, adding that "We are in the range of 8 to 9 percent, and I would like to push it below 5 percent before we start the clinical trial." The cassette consists of hybridization reagents needed for a single test and captures waste materials generated during testing.

He said that he believes that other diagnostic companies might start clinical trials with the failure rates Luminex is currently experiencing, "but because we don't have a gun to our heads…we are not in a rush to start it."

"We are in the business of making money, and we need to make sure that we launch a product where we can make money almost from the beginning," he added.

The firm is looking to assay and system sales — and particularly its sample-to-answer products revenues — to offset headwinds in other business segments. In Q2, revenues from the firm's consumables business was flat due to timing issues, after growing by 30 percent year over year in Q1. For the full year 2017, the firm expects that consumables revenues will be flat year over year, because its business will be impacted by funding challenges related to a bulk-bead contract with a life science customer.

In Q2, royalty revenues were down 5 percent year over year because of the timing of revenue recognition, said the firm's CFO Harriss Currie.

The firm expects that it will need to offset a $30 million revenue headwind in 2018, as LabCorp is likely to end a contract for genetic assays.

Weinstein said that the investment bank remains concerned about the coming influx of competition for the Nanosphere core microbiology business, which represents somewhere between 50 percent and 65 percent of revenue, and respiratory assays.

Piper Jaffray analyst William Quirk wrote in a note this week that it is maintaining a Neutral rating on Luminex, also due to long-term competitive concerns, but to their credit, he said, Luminex management is "executing well with existing assets."

Greater certainty in Japan is offsetting reimbursement uncertainty in the US for Luminex. The firm said that in Q2 it received reimbursement approval in Japan for its Verigene gram-positive and gram-negative blood culture assays. Shamir said that Japan has about 1,000 hospitals that could use the system. He noted that at first the firm will focus on achieving system placements and later it will drive reagent sales there. He added that Hitachi "is looking like a strong partner to do business there" by distributing Luminex blood culture assays, and that the firm expects to see results from those initiatives during the next couple of years.

He noted that the firm had more than $100 million in cash and short-term investments on its books at the end of Q2, and with the Nanosphere integration complete, it continues to evaluate companies within and outside of its molecular segment with a view to acquiring them.