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GenMark Provides New Details on NexGen System Launch; Nanosphere Readies Enteric Panel

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NEW YORK (GenomeWeb) – GenMark Diagnostics and Nanosphere, two firms that sell molecular diagnostics platforms based on multiplexing technologies, recently provided updates on plans to expand their respective test menus and to develop next-generation instruments.

GenMark Diagnostics is inching closer to commercializing its automated, sample-to-answer NexGen system, and anticipates a small number of placements in Europe later this year ahead of a planned 2015 product launch in the US.

CEO Hany Massarany provided an update on the NexGen system and its initial menu of tests during a first quarter earnings call with investors last week. GenMark currently offers a number of US Food and Drug Administration-cleared assays for use on its semi-automated eSensor XT-8 System: its Respiratory Viral Panel, its Warfarin Sensitivity Test, its Thrombophilia Risk Test, and its Cystic Fibrosis Genotyping Test. The company also offers a number of research-use-only assays, such as its HCV Genotyping Test.

According to Massarany, GenMark is planning an "extensive test menu" for the NexGen platform, with an initial focus on infectious disease. He discussed seven assays on the call: a respiratory viral panel, a gastrointestinal infection panel, an HCV genotyping panel, a panel for central nervous system infections, gram-positive and gram-negative sepsis panels, and a panel for pathogens associated with invasive fungal infections.

"The rate of invasive fungal infections is increasing, and delays in appropriate diagnosis and therapy initiation increases the length of hospital stay and is associated with increased mortality rates and healthcare costs," Massarany said of the new test. "A NexGen panel addressing invasive fungal infections and providing rapid sample-to-answer performance will address a critical unmet clinical need, and we're very pleased to have begun work on this assay," he said.

Massarany noted on the call that the market for such a test is between $50 million and $60 million globally, and said the test is "an important panel to have in conjunction with the others that we're developing."

GenMark intends to file all of the NexGen assays with the FDA for clearance in the first part of next year. Massarany said that all of them, save the HCV genotyping panel, will be 510(k) submissions. For its part, the HCV panel will most likely require pre-market approval, a regulatory review process for devices that the agency deems to be of higher risk.

Massarany said that GenMark is investing in its commercial organization ahead of the planned launches in Europe and the US. He said that the company currently has a commercial team of about 40 people worldwide, most of whom are sales representatives, but that the company will need more than 50 sales people to support the roll out of NexGen over the next year.

Though its main focus in coming months will be on NexGen, GenMark will not neglect its XT-8 customers, Massarany noted.

"The XT-8 will continue to be an area of focus for us since we're not replacing many of the tests," Massarany said. "We will focus NexGen on infectious disease, and we expect to continue to support XT-8 and our XT-8 customers for other tests that they're using today," he said.

Nanosphere readies enteric panel

Nanosphere is betting on US Food and Drug Administration-clearance of its Enteric Pathogens Test to drive revenue growth this year. The company in February forecast 2014 revenues of between $19 million and $21 million, roughly double the $10 million it generated in 2013.

In January, the Northbrook, Ill.-based firm submitted its enteric panel to the FDA for clearance. The assay tests for a wide spectrum of organisms associated with food poisoning that are treated with various antibiotics and other drug therapies.

CFO Roger Moody said on Nanosphere's first-quarter earnings call last week that regulatory clearance of the enteric panel will "nearly double our revenue opportunity from our current menu." The company also sells FDA-cleared gram-positive and gram-negative sepsis tests, and sales of its gram-positive sepsis test generated most of its $3.3 million in Q1 revenues. Nanosphere has projected mid-year clearance for the test.

The company is also developing a new version of its Verigene instrument that will "allow for a number of customer-driven improvements" and enable it to compete against firms with similar test menus, including GenMark Diagnostics, Luminex, and BioFire Diagnostics.

According to President and CEO Michael McGarrity, Nanosphere is seeking to make the Verigene system more user friendly.

"I would say that our focus historically was on conversion from an original genetic approach to testing and ... not necessarily on the best customer interface," McGarrity said. "We are confident that we can execute on the key improvements that will put us in [a] competitive situation against those platforms with our menu," he added.

Nanosphere already has two instruments in the marketplace: it's Verigene System, which it refers to as the Verigene OP, or original processor; and its sample-to-answer Verigene SP, which incorporates sample preparation. Both rely on its gold nanoparticle probe multiplexing technology. According to the company's 10-Q, it is referring to its new instrument in development as the Verigene SP+.

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